UK to face short term delay in delivery of Pfizer vaccine

Overall number of doses delivered between January and March will remain the same, the firm says

The UK is set to face short-term delays in delivery of the Pfizer/BioNTech coronavirus vaccine as the pharmaceutical company upgrades its production capacity.

Pfizer is upscaling production at its plant in Puurs, Belgium, in efforts to produce more doses than originally planned for 2021 – temporarily reducing deliveries to all European countries.

Continue reading…

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.

The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.

Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.

The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.

The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.

J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

The post J&J single-shot COVID-19 vaccine shows early promise appeared first on .

PharmaShots’ Key Highlights of Fourth Quarter 2020

  • The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
  • Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ’s COVID-19 vaccine. Meanwhile, AZ’s AZD1222 met its primary endpoint in preventing COVID-19
  • Our team at PharmaShots has summarized and complied with the insights of Q4’20

Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Date – Oct 01, 2020

Product – Tetraxim

  • Sanofi’s Tetraxim combines four vaccines into one and provides protection against four diseases – Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
  • Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
  • Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of 60mg with Palynziq (pegvaliase-pqpz) for PKU

Date – Oct 08, 2020

Product – Palynziq (pegvaliase-pqpz)

  • The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
  • The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels ≤120 μmol/L @2yrs. 75%, 66% & 48% had a blood Phe ≤600, 360, and 120 μmol /L, respectively @3yrs. of treatment
  • Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU

AbbVie Reports Results of Skyrizi (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Date – Oct 08, 2020

Product – Skyrizi (risankizumab)

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

 Date – Oct 09, 2020

 Product – REGN-COV2

  • Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
  • The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
  • REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

 Date – Oct 29, 2020

 Product – BI 764198

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

Date – Oct 30, 2020

Product – Tecentriq + Avastin

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

 Date – Oct 30, 2020

 Product – Keytruda

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 study for Moderately to Severely Active Crohn’s Disease

 Date – Oct 30, 2020

  Product – Tremfya

  • The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
  • @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
  • @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Date – Nov 02, 2020

Product- BNT162b2

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Date – Nov 02, 2020

Product- Crestor

  • Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
  • The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
  • Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Date – Nov 02, 2020

Product- Xolair

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Date – Nov 03, 2020

Product – CT-P17(biosimilar,adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Date – Nov 03, 2020

Product – FPI-1434

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Date – Nov 03, 2020

Product- HMR59

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasi

Date – Nov 04, 2020

Product- Deucravacitinib

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Date – Nov 04, 2020

Product- amivantamab

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Merck to Acquire VelosBio for $2.75B

Date – Nov 05, 2020

Product- VLS-101

  • Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
  • The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
  • In Oct’2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Date – Nov 05, 2020

Product- N/A

  • Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program
  • The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO
  • Iktos’ AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Date – Nov 05, 2020

Product- NVX-CoV2373

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Date – Nov 07, 2020

Product- Hemlibra

  • The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
  • Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
  • Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Date – Nov 09, 2020

Product – CT-P59

  • The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
  • Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
  • Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Date – Nov 10, 2020

Product- Calquence (obinutuzumab)

  • The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
  • ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
  • Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Date – Nov 12, 2020

Product- Abrocitinib

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

Date – Nov 13, 2020

Product – Handl Therapeutics

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma

Date – Nov 16, 2020

Product- HLX15  

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Date – Nov 20, 2020

Product- BNT162b2

  • collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
  • Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
  • Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Date – Nov 23, 2020

 Product – AZD1222

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Date – Dec 15, 2020

Product- Cobas PIK3CA Mutation Test

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Date – Dec 16, 2020

Product- SARS-CoV-2 IgG II Quant test

  • Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
  • The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
  • The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Date – Dec 15, 2020

Product- COVID-19 vaccine

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Related Post: PharmaShots’ Key Highlights of Third Quarter 2020

The post PharmaShots’ Key Highlights of Fourth Quarter 2020 first appeared on PharmaShots.

Second shots of Covid vaccine could be delayed further in England

Evidence growing that spacing doses of Pfizer vaccine improves effectiveness

Second shots of coronavirus vaccine could be delayed even further amid growing evidence that spacing out the doses improves their effectiveness.

The NHS vaccination programme aims to immunise about 14 million people at greatest risk of Covid by mid-February with second doses due to be given up to 12 weeks later.

Related: Vaccine supply is holding back jabs programme, says Matt Hancock

Continue reading…

Australia’s chief medical officer defends AstraZeneca’s Covid vaccine amid efficacy concerns

Australia has secured 54m doses of the vaccine some experts say is inferior to Pfizer’s mRNA vaccine, which Australia has bought just 10m doses of

  • Covid hotspots Victoria; NSW hotspots; Queensland hotspots
  • NSW and Sydney trend map: where cases are rising or falling
  • Follow the Australia coronavirus live blog
  • Australia’s chief medical officer Professor Paul Kelly and infectious diseases experts have defended securing 54m doses of a Covid-19 vaccine made by Oxford University and pharmaceutical company AstraZeneca, amid concerns the vaccine will not be effective enough to achieve herd immunity.

    The president of the Australian and New Zealand Society for Immunology, Prof Stephen Turner, told Nine media that Australia should halt the AstraZeneca vaccine rollout because it has “lower efficacy”.

    Related: Australia’s Covid vaccines: everything you need to know

    The choice we have is not whether to use one or the other, it is whether to use what we have

    Related: ‘How dare you leave’: confusion remains for some Victorians stranded interstate

    Continue reading…

    EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

    The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month.

    The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting on 29 January, and if all goes well it could be authorised on that day, according to the regulator.

    The European Commission will then fast-track its decision-making process, says the EMA, with a view to granting a conditional marketing authorisation “within days”, a timeframe which was welcomed by Commission President Ursula von der Leyen.

    AZ’s AZD1222 shot – which was developed with Oxford University – was cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December, and since then it has also been given emergency approval in several other countries including India.

    The filing comes as the EU is facing criticism for the slow roll-out of its coronavirus vaccination programme as infection rates soar in the 27 member states.

    While individual EU countries make the decisions about who to vaccinate, the Commission is coordinating the acquisition and allocation of supplies, and there have been complaints the process is taking too long.

    The US and Britain have both vaccinated 1%-2% of their populations, according to an Economist report citing figures from the Our World in Data website, while Israel is leading the field at 16%. In contrast, Germany has managed just 0.4%, France didn’t cross the 1,000 threshold until 4 January, and the Netherlands only started vaccinating until 6 January.

    So far the EMA has conditionally approved two coronavirus vaccines – Pfizer/BioNTech’s Comirnaty last month and Moderna’s candidate last week – and swift approval of the AZ vaccine should allow an acceleration in vaccination rates in the EU.

    As it stands, the UK has vaccinated more people than the entirety of the EU combined, with the latest government figures indicating 2.3 million people have now received the first of two required doses, saying it plans to immunise all adults in the country by the autumn.

    So far the effect of vaccination is imperceptible, however, as the UK recorded more than 46,000 new cases of COVID-19 yesterday, and 529 deaths, with NHS capacity creaking under the weight of over 32,000 people hospitalised with the infection.

    The EU has 400 million doses of the AZ vaccine on order, part of a procurement programme that so far extends to 2.3 billion doses.

    Last week the Commission said it intended to order an additional 200 million doses of the BioNTech/Pfizer, with the option to acquire another 100 million doses, taking its total to 600 million doses.

    It has also agreed deals for the supply of 160 million doses of the Moderna shot, 400 million apiece for candidates in testing at Johnson & Johnson and CureVac, and 300 million of a Sanofi/GlaxoSmithKline candidate that has been delayed by clinical trial snags.

    The post EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January appeared first on .

    AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

    Shots:

    • The companies collaborated to evaluate the use of immunoSEQ T-MAP, for which Adaptive will receive quarterly payments + sequencing and data mapping fees
    • AstraZeneca to provide cancer patients’ biological samples while Adaptive will sequence the samples & deliver TCR-antigen mapping data using its clinical immunomics database of 58B+ immune cell receptors and antigens
    • AstraZeneca gets an option to enter into an agreement with Adaptive for the development & commercialization of a CDx or therapeutic application based on T-MAP data. ImmunoSEQ T-MAP combines the sequencing and mapping capabilities of Adaptive to map TCRs to antigens, across AZ’s oncology portfolio

    Click here ­to­ read full press release/ article | Ref: Adaptive | Image: Glassdoor

    The post AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer first appeared on PharmaShots.

    Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

    Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes.

    The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.

    Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs used to treat type 2 diabetes, driving blockbuster sales for the brand.

    It was the top-selling drug in the SGLT2 inhibitor class in 2019, with sales of almost $3 billion, helped by side-effect problems that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson.

    However its rivals – which also include AstraZeneca’s Farxiga (dapagliflozin)  – have moved more swiftly into areas like heart failure and chronic kidney disease (CKD) which have made large numbers of new patients eligible for treatment with the class.

    The new FDA review – covering Jardiance as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) in patients with and without diabetes – is Lilly and Boehringer’s first chance to fight back.

    Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million. AZ picked up EU approval for the same indication the following November.

    Lilly and Boehringer will be hoping for a swift FDA review so that Jardiance will not fall too far behind its competitor in the heart failure category, and that looks likely as the benefit in HFrEF increasingly appears to be an SGLT2 class effect.

    GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

    It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF this year. The bulk of those sales will come from HFpEF, however,  as in this form of heart failure there is a huge unmet need and no approved therapies.

    Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

    Meanwhile, EMPEROR-Reduced also showed a slowdown in the rate of decline in kidney function among patients with HFrEF, an effect that Lilly and Boehringer are exploring in the CKD patient population in the EMPA-KIDNEY trial due to generate results in 2022.

    Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease. After a couple of years of declining sales due to concern about a risk of lower limb amputation, Invokana managed a 25% gain to $224 million in third-quarter 2020.

    Farxiga meanwhile has already been filed for CKD on the back of the DAPA-CKD trial, with a verdict due in the second quarter.

    The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on .

    PharmaShots Weekly Snapshot (Jan 4-8, 2020)

    Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

    Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies

    Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD   

    Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD

    PerkinElmer to Acquire Oxford Immunotec for ~$591M

    Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M

    Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

    Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD

    Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

    Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy

    Bayer Collaborates with CureVac for CVnCoV Against COVID-19

    Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19

    Hologic to Acquire Biotheranostics for ~$230M

    Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M

    Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

    Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology

    Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

    Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities,  Vaccines, Treatments, Diagnostics

    Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

    Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies

    Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

    Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension

    Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

    Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy

     Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test    

    Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test

    AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

    Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease

    AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

    Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis

    Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD

    Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202

    Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

    Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones

    Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology

    Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology

    Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

    Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development

     Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

    Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013

    aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

    Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19

    Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

    Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer

    Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

    Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)

     Hologic to Acquire Somatex for ~$64 M   

    Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M

    Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D  

    Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D

    Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms

    Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms

    Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

    Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil

     Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea     

    Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea

    AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

    Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India

    RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

    Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19

    Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

    The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.

    Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

    As COVID-19 vaccines are hastily deployed in the UK for priority groups, a debate rages over the government’s controversial strategy to delay time between vaccine doses.

    When the UK announced the approval of the Pfizer-BioNTech and Oxford/AstraZeneca COVID-19 vaccines, it marked an exciting moment for the nation.

    After months of turbulent lockdown measures, the dawn of approved vaccinations signalled hope COVID-19 could finally be under control.

    Sadly, the chaos is continuing as the UK grapples with the emergence of a new variant of SARS-CoV-2, estimated to be up to 70% more transmissible than the previous form of the virus.

    As cases surge, the UK’s decision to delay second doses of the vaccine beyond the 3-4 weeks tested and approved during Phase III clinical trials is causing widespread concern. Many believe the strategy is too risky – prioritising political expediency over science and using the British public as laboratory subjects during an already severe crisis.

    The advice, which first came from the UK’s Joint Committee on Vaccination and Immunisation (JCVI), stated a maximum interval of 12 weeks should take place between the first and second doses of both Pfizer and AstraZeneca’s vaccines.

    JCVI said this is likely to have a greater public health impact in the short term and reduce the number of preventable deaths from COVID-19.

    “The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity,” said the committee.  “An extended interval between vaccine doses together with initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier.”

    The advice has been endorsed by the UK’s four chief medical officers but has been met with backlash from the medical community. Many healthcare workers have aired grievances on Twitter protesting the changes.

    The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”.

    “The Government must see that it’s only right that existing bookings for the oldest and most vulnerable members of our society are honoured, and it must also as soon as possible publish a scientifically-validated justification for its new approach,” said the BMA.

    “As doctors, we believe this can and should be done even as practices and the wider NHS step up the COVID-19 vaccination programme to deliver initial doses of vaccination to other vulnerable people, including frontline healthcare professionals – many of whom still have not even received their first vaccination.”

    ‘Erosion of public trust’’

    The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why.

    “We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorised dosing schedule for each COVID-19 vaccine”

    “Protecting frontline staff from infection is vital to help them care for patients with COVID, as well as delivering the vaccination programme,” said NHS Confederation director Layla McCay.  “However, there has been concern about changes to the vaccination schedule, which were announced at short notice and led to confusion and anxiety for patients and could lead to an erosion of public trust in healthcare providers. As always, NHS teams will pull out all the stops to respond to changing guidance, but the government must do more to explain the rationale for this change.”

    Internationally, the decision has been met with scepticism. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccines to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

    “We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”

    In a joint statement Pfizer and BioNTech warned there was no data to demonstrate that protection after the first dose is sustained after 21 days. “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” said the companies.

    Industry support

    The Oxford-AstraZeneca vaccine trial did include difference spacing between doses and showed longer gaps (two to three months) yielded a greater immune response. The combined trial results published in the Lancet showed that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).

    Andrew Pollard, head of the Oxford Vaccine Group and chief trial investigator vaccine told the BMJ that extending the gap between doses made sense.

    “Generally, a longer gap between vaccine doses leads to a better immune response, with the second dose causing a better boost. (With HPV vaccine for girls, for example, the gap is a year and gives better responses than a one-month gap.) From the Oxford vaccine trials, there is 70% protection after the first dose up to the second dose, and the immune response was about three times greater after the second dose when the second dose was delayed, comparing second dose after four weeks versus second dose after two-three months.”

    Akiko Iwasaki, professor of immunobiology at Yale Medical school also tweeted support for the changes, stating the new SARS-CoV-2 variant as the deciding factor.

     

    “I am still a proponent of two-dose vaccine but given the urgency, we can delay the seconnd dose until more vaccines become available. I know many others have been saying this all along, but it was the B.1.1.7 variant transmission rate that did it for me,” said Iwasaki.

    David Grainger, chief scientific advisor at life sciences investment firm Medicix, also expressed confidence in the strategy, referring to modelling by the University of Toronto that predicts increasing the number of people protected, by limiting individuals to a single dose, reduces severe COVID events (ICU stays and death) by between 30-40% over a 6-month period. This could amount to over 20,000 lives saved.

    “The vaccine only must be 50% effective in two people to reduce the overall risk of infection that is achieved with 95% protection in one person,” said Grainger. “If I protect 10,000 people out of a population of 20,000 with 1% risk of infection at 95% efficacy, I get five cases from the protected subgroup and 95 cases in the unprotected subgroup for a total of 100 infections; if I protect all 20,000 people with 50% efficacy, again I get 100 infections. The existing data strongly suggests that a single dose will deliver at least 50% protection for at least a few months.”

    He added that during the pandemic, decisions often needed to be made in the absence of proper data. “It teaches us that we cannot just ‘follow the science’ because that pathway is way too conservative (at least if that means only do things for which there is clear, direct evidence).

    “This is why we should have scientific advisors, but not rely on scientists to make decisions. It is why scientists rarely make good investors or businessmen – too many decisions need to be made in the absence of much information.”

    The post Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy appeared first on .

    UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

    The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.

    With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

    The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.

    As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

    Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.

    The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.

    US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.

    Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.

    The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.

    There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.

    After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.

    Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.

    Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.

    In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion

    The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.

    But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.

    Questioned by pharmaphorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.

    However Moderna said separately that it is in talks with the MHRA to get the vaccine approved.

     

     

     

    The post UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine appeared first on .

    Britain could be mass-producing its Covid shot. Shame we junked our industrial base | Aditya Chakrabortty

    The dire state of UK manufacturing has left us dependent on other nations. We may soon find out why some call this a ‘national security risk’

    Everything now hinges on a vaccine: how many more Britons die, whether the NHS finally breaks, how long the UK stays locked down. All depends on how fast the country can get vaccinated against this plague. Yet we’re in this position in large part because of government failure. When the prime minister imposes lockdowns late and with a sulky grumble; when we haven’t fixed our £22bn test-and-trace system (which, by the way, now bankrolls more outside consultants and contractors than the Treasury has actual civil servants); and when the Dominics and Stanleys are allowed to carry on as if rules are for the little people. If Boris Johnson blunts every political instrument he can lay his pale and meaty hands on, pretty soon a syringe is the only resort.

    Vaccines were always going to be how the world limped out of this pandemic; but as Taiwan and New Zealand show, even without inoculation it is possible to drive the number of Covid cases significantly down. Compare their record with the UK – which is on course to hit 100,000 Covid-related deaths before January is out, and where a staggering one in 30 Londoners is today infected. The lecterns from which Johnson and his top advisers gave their press conference this week read “Stay Home. Protect the NHS. Save Lives” – exactly as they did at the start of all this last March, as if to confirm how little progress they have made in almost a year.

    Related: For mRNA vaccines, we should stick to the schedule | Angela Rasmussen and Ilan Schwartz

    Continue reading…

    UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens

    The UK government has promised a “massive uplift” in the number of coronavirus vaccinations carried out this week, while conceding a target of 13.9 million jabs offered by the end of February will be “challenging”.

    As the number of daily recorded cases in the country exceeded 60,000 for the first time, vaccine minister Nadhim Zahawi told BBC Radio 4’s today programme: “My absolute focus is to get to 13.9 million…offered a vaccine by the middle of February.

    “That is my target and I’m confident the NHS has a plan and we will meet that target.”

    The number of vaccinations will continue to rise, he promised, adding that a quarter of over-80s had already been vaccinated.

    Zahawi stopped short of saying when the government would reach the 300,000 vaccinations a day required to meet the goal.

    More than a million people are thought to be infected with virus at the moment and hospitals across in the worst-affected areas are running at full capacity because of the disease.

    All of the country is now in a strict lockdown, with mixing indoors banned and people instructed to stay except to get exercise and other essential tasks such as buying food.

    According to reports elsewhere there are a number of backlogs that are causing delays to the roll-out of the vaccine from AstraZeneca, which will be offered to the majority of patients.

    The UK has ordered 100 million doses of the vaccine and AZ has reportedly manufactured around 3.5 million doses in addition to the half million or so shots that are already available.

    But Sky News reported that the extra doses are still waiting to be batch tested by the country’s regulator, the Medicines and Healthcare Products Regulatory Agency.

    Sky reported that the MHRA is working in parallel with AstraZeneca’s own batch testing system to speed up a process that usually takes up to three weeks.

    There are also issues with Pfizer/BioNTech vaccine, which is not manufactured in the UK like the AZ shot but in Belgium.

    It has already been placed into glass vials by the time it arrives in the country, but a worldwide shortage of these means that five million doses have been delivered.

    This is less than half the number that should have been because of the problems with manufacturing including the fill-and-finish process, according to the BBC.

    Feature image courtesy of NIH/Rocky Mountain Laboratories

     

    The post UK promises ‘uplift’ in COVID-19 vaccinations as crisis deepens appeared first on .

    No data to support UK delay of vaccines’ second dose, says WHO

    Move to postpone second jab by up to 12 weeks is not supported by scientific evidence, experts find

    There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.

    The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.

    Continue reading…

    FDA and doctors warn against extending COVID-19 vaccine dose gap

    Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots.

    The regulator made its comments after the UK announced a policy of stretching the gap between doses of the vaccine to up to 12 weeks to ensure maximum coverage of vulnerable groups.

    The UK’s Joint Committee for Vaccines and Immunisation (JCVI) has recommended prioritising the first shot of the vaccines from Pfizer/BioNTech and AstraZeneca – but said that the follow-up booster dose can be delayed by up to 12 weeks.

    According to the UK’s drug regulator the Pfizer/BioNTech vaccine doses should be taken at least 21 days apart while AZ vaccine’s booster doses should be given between four and 12 weeks apart.

    But the FDA has issued a statement warning against such a strategy and reminded the public about the importance of receiving their second dose on time.

    In the US, the Pfizer and BioNTech vaccine and a rival from Moderna is approved with a four-week gap between doses, but the AstraZeneca vaccine is not.

    The FDA said it had been monitoring discussions and news reports about the policy and concluded that extending the time between doses, changing the dose and mixing and matching vaccines are “reasonable questions” to consider and evaluate.

    But in a strongly-worded statement it said that changing the vaccine schedule without evidence could “undermine the historic vaccination efforts to protect the population from COVID-19.”

    There are concerns elsewhere that the extended dosing schedule could also lead to resistant forms of the virus taking hold at a time when there is a new and highly infectious variant spreading through the UK.

    In the US, doctors pointed out that the slow roll-out of the vaccines is due to logistical challenges rather than supply and urged authorities to focus on this rather than delaying the dosing schedule.

    In the meantime, the UK government has pushed ahead with plans to vaccinate everyone in the four highest-priority groups by mid-February.

    This will require the NHS to start delivering at least two million shots a week from next week.

    AZ’s chief executive Pascal Soriot said it would be possible to manufacture the required vaccines, although it remains to be seen whether output will be increased in time to hit the target.

    The government said it already has a batch of 530,000 doses and a further 450,000 are reportedly due to be available by the end of week according to Oxford University’s regius professor of medicine Sir John Bell.

    Several million more doses of the vaccine are understood to have been manufactured but have not yet been bottled in vials.

    The post FDA and doctors warn against extending COVID-19 vaccine dose gap appeared first on .

    AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

    Shots:

    • India has granted the emergency use approval for AstraZeneca and the Oxford University’s COVID-19 vaccine developed by a day after an advisory panel of CDSCO issued its recommendation
    • Covishield would be the first vaccine to be given the go-ahead by drug regulators in India. SII and AstraZeneca have partnered up to manufacture and distribute the vaccine in India and several other countries
    • Discussion for the EUAs are underway for Bharat Biotech’s COVAXIN, Zydus Cadila’s ZyCoV-D, and Russia’s Sputnik-V. India plans to inoculate 300M of its 1.35B people in the first six to eight months of 2021

    Click here ­to­ read full press release/ article | Ref: Hindustan Times | Image: The Economic Times

    The post AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19 first appeared on PharmaShots.

    Analysis: is it wise for England to mix and match Covid vaccines?

    US experts warn against plan to give different second jab if supplies run low

    The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks like public health pragmatism rather than strict adherence to evidence.

    Britain is the first country in the world to approve and use the Oxford/AstraZeneca vaccine, just as it was first with Pfizer/BioNTech’s. In a further trailblazing decision, it is giving everyone a first shot of either of those vaccines, with the second shot delayed to 12 weeks afterwards instead of the three- or four-week interval in the trials.

    Continue reading…

    How is the Oxford Covid vaccine being deployed in England?

    With jab to be administered to public for first time, we look at key questions about its rollout

    The biggest vaccination programme in the UK’s history will receive a major boost on Monday, with the first use of the Oxford/AstraZeneca Covid vaccine. We answer some key questions around how it will be deployed in England.

    Related: UK hospitals receive Oxford/AstraZeneca Covid vaccine for Monday rollout

    Continue reading…

    The Oxford Covid jab is delivered this week. But when will vaccines bring results?

    Fall or rise in coronavirus cases will not initially be a good measure of efficacy, say scientists devising ways to audit progress

    People in Britain are set to get their first shots of the Oxford/AstraZeneca vaccine on Monday, with millions of doses being given over the next few months. The mass vaccination of the UK’s population should bring an end to the country’s Covid-19 misery, but how long will it take for this immunisation programme to make a difference to our lives – and what will be the first signs that salvation is on the way?

    These key issues will be anxiously pursued as the battle against Covid proceeds and daily cases involving the new virus variant continue to spread. However, scientists have warned that simply waiting for a reduction in new cases it not the way to tell whether the vaccine is starting to have an impact.

    Related: Symptomless cases in schools could be key driver in spread of Covid-19

    Related: Why is Britain delaying second doses of Covid vaccines?

    Continue reading…

    What difference will Oxford/AstraZeneca vaccine make in UK?

    We look at how the introduction of a new vaccine in the fight against Covid will work

    The Oxford/AstraZeneca vaccine is central to the government’s plans for ending social distancing in the UK and returning to some sort of normality. It has invested in seven different vaccines, but the biggest order is for 100m doses of the AstraZeneca jab, most of which will be manufactured in the UK. While the prime minister was jubilant that the UK was first in the world to approve the Pfizer/BioNTech vaccine, he is now able to claim a British triumph. More to the point is the ease of use of the AstraZeneca vaccine. Unlike Pfizer’s, it does not have to be kept in the long term at -70C. Pfizer’s vaccine can be stored in a fridge for five days, but AstraZeneca’s can be kept for months at fridge temperature, which is 2-8C and will be easy to take to care homes to administer to residents, the first priority group for vaccination.

    Related: BioNTech criticises EU failure to order enough Covid vaccine

    Related: World leaders urged to make Covid vaccine available to millions of refugees

    Continue reading…

    PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

    Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

    Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm

    Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

    Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex

    The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

    Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA

    Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

    Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission

    Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

    Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine

    Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

    Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs

    Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

    Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila

    Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

    Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial

    AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

    Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK

    Skyhawk Collaborates with Vertex to Discover and Develop Novel Small Molecules Modulating RNA Splicing for Serious Diseases

    Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex

    Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

    Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D

    Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

    Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA

    Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

    Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits

    Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

    Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA’s

    Biocon has Launched Tacrolimus Capsules in the US

    Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US

    Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

    Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women

    Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

    Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission

    Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

    Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab

    Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

    Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports

    Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

    Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

    Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

    Published: Dec 23, 2020 | Tags: Amyrt’s, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA’s

    Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

    Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine

    Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent Glioblastoma

    Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA

    Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

    Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA’s Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno

    Related Post: PharmaShots Weekly Snapshots (Dec 21-23, 2020)

    The post PharmaShots Weekly Snapshots (Dec 28- 31, 2020) first appeared on PharmaShots.

    PharmaShots’ Most Read News of 2020

    “Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.

    1. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the US

    • Dare to receive up front, $20M as option exercise fee, $310M as commercial milestones, royalties on sales of the product along with access to Bayer’s clinical and market capabilities and remain responsible for development & regulatory activities of Ovaprene
    • Bayer to get exclusive right to commercialize Ovaprene in the US, once approved by the FDA. Dare is expected to file IDE for the therapy in H1’20 and the initiation of its clinical study in H2’20 following FDA’s review and clearance of the IDE
    • Ovaprene is an investigational hormone-free monthly vaginal contraceptive, currently in development for the prevention of pregnancy and if approved, will be the first monthly non-hormonal contraceptive therapy

    2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

    • Theramax acquires commercialization rights of Zoely, allowing it to commercialize the therapy in 50+ countries globally. Earlier, Theramax has right to commercialize Zoely in eleven countries in the EU while MSD retains rights in the US and Canada
    • The acquisition of further rights of Zoely expands Theramex global footprints by providing innovative therapies to maintain the healthcare of women
    • Zoely is a combined oral contraceptive therapy consisting of two steroid hormones: 17-beta estradiol and nomegestrol acetate

    3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs

    • Rockfeller to receive up front, milestones plus royalties on sales and will retain rights to perform non-clinical and early-stage clinical research on the portfolio of HIV Abs. Gilead to get exclusive rights to develop and commercialize Rockefeller’s full portfolio of HIV bNAbs
    • The focus of the agreement is to enhance Gilead’s HIV pipeline and will advance academic programs into potential future products
    • 3BNC117 and 10-1074 are clinical-stage products with the ability to be used as HIV long-acting therapies for treatment and prevention

    4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

    • Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system
    • CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & is compatible with various imaging modalities. It automatically engages with white light or LCI mode to improve the accuracy of lesion detection
    • CAD EYE is customized detection support used with the ELUXEO system, aimed to improve lesion detection in the colon at the expert level and is expected to be available with EX-1 in Mar’2020

    5. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

    • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
    • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
    • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

    6. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Receives the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

    • The approval is based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
    • The study resulted in well-tolerated data and lowered LDL-C by 38%, when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
    • Nexlizet is an oral qd, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

    7. AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

    • The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries
    • The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the second arm (Imfinzi + tremelimumab) did not meet its 1EPs of OS. The safety profile of each therapy is consistent with the known safety profiles
    • Imfinzi (durvalumab) is mAb targeting PD-L1, acts by blocking the interaction of PD-L1 with PD-1 & CD80 and is currently under review in combination with etoposide and carboplatin/cisplatin as 1L treatment for ES-SCLC in the US, EU and Japan with its anticipated PDUFA date in 2021

    8. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

    • Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both)
    • The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label change for use in insulin infusion pumps is based on Health Canada’s review of data from 5 clinical studies which demonstrated the efficacy of Fiasp used in insulin infusion pumps in adults with diabetes
    • Fiasp is the first and only fast-acting mealtime insulin injection, administered at the beginning of a meal or within 20 minutes after starting a meal and has received FDA’s approval as an IV infusion or SC MDI in adults with diabetes

    9. Merck KGaA’s ERBITUX (cetuximab) Receives NMPA’s Approval as a 1L treatment for Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

    • The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN, prior not treated with any systemic therapy in China
    • The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.), ORR (50% vs 27%) with no new safety findings
    • ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

    10. Bausch Health to Initiate Clinical Study Evaluating Virazole (Ribavirin for Inhalation Solution, USP) in Patients with COVID-19 in Canada

    • The clinical study will evaluate the safety and efficacy of Virazole + SOC in hospitalized patients aged ≥18yrs. with respiratory distress due to COVID-19
    • The clinical study has been approved by Health Canada and is expected to initiate within the next few weeks. The company is working with multiple health authorities including the US FDA regarding additional studies to assess Virazole as a treatment for COVID-19 infection
    • Virazole (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. The Bausch Foundation is working with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in hospitals

    11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19

    • Adaptive to expand its platform for selection of B cell receptors of recovered patients from COVID-19. Amgen will utilize its Ab engineering and drug development capabilities to select and develop Abs designed to bind and neutralize SARS-CoV-2. Additionally, Amgen ‘s subsidiary DeCODE Genetics located in Iceland, will provide genetic information from patients infected with COVID-19
    • The focus of the collaboration is to combine expertise to discover and develop fully human neutralizing Abs for SARS-CoV-2 virus to treat COVID-19 where Adaptive’s immunological medicine platform will help in identification of virus neutralizing Abs
    • Additionally, the Abs can be used to treat patients with COVID-19 and can be administered to patients with who are at increased risk of exposure to SARS-CoV-2

    12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

    • The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US
    • The dose-escalation portion of the P-I/II study will include ~200 healthy participants aged 18-55yrs. and will target a dose range of 1-100 µg, focusing on determining the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine
    • The study will evaluate the effects of repeated vaccination following a prime injection for 3 vaccine candidates that contain uRNA or modRNA. The fourth vaccine candidate contains saRNA will be evaluated following a single dose of vaccine. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct clinical studies

    13. Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany

    • Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec’s will market the biosimilar therapy
    • Last year, Fresenius Kabi launched IDACIO in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
    • Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab

    14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478

    • Idorsia to receive $45M upfront in cash, $365M for development & regulatory milestone, one-time sales threshold and royalties on sales. Additionally, will receive $7M in funding to discover, identify and develop additional novel T-type calcium channel blockers
    • Neurocrine exercises its option to license rights for ACT-709478 (post IND acceptance from the US FDA on Apr 30, 2020) for rare pediatric epilepsy. In 2019, Neurocrine and Idorsia signed a preclinical research collaboraion for ACT-709478 to treat rare pediatric epilepsy
    • ACT-709478 is an selective, orally-active and brain penetrating T-type calcium channel blocker also received the US FDA’s Rare Pediatric Disease designation for rare pediatric epilepsy with completion of P-I in 2019 and expected P-II initiation in in H2’20

    15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

    • The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020
    • The focus of the collaboration is to enable the manufacturing of mRNA-1273 up to 1B doses/year and anticipates the manufacturing of the first batches of mRNA-1273 at Lonza US site in Jul’2020, assuming the currently expected dose of 50µg
    • Manufacturing operations at Lonza US site is covered by Moderna’s agreement with BARDA under which BARDA will support late-stage clinical development programs of mRNA-1273. On Apr 27, 2020, Moderna has submitted IND to the US FDA for P-II studies with its expected initiation in Q2’20

    16. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

    • The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
    • In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
    • Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019, the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

    17. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

    • The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s Remedisvir called CIPREMI
    • Cipla has received DCGI’s approval for restricted emergency use in India as part of the accelerated approval process. Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a P-IV clinical trial on Indian patients
    • As per ACTT-1 study, 1063 patients were treated with Remdesivir vs PBO over 60 centers across the US, EU and Asia demonstrated faster time to clinical recovery in hospitalized patients with the mortality rate as (7.1% vs 11.9%)

    18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

    • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
    • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
    • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

    19. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside the Japan

    •  Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
    • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
    • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production

    20. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

    • The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
    • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively
    • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

    21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

    • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
    • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
    • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patient

    22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

    • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
    • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
    • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

    23.  Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

    • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of an update to the Beovu prescribing information globally
    • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
    • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) that enhances tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors, and mitigation of AEs

    24. Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

    • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
    • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
    • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

    25. Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

    • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
    • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
    • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

    26. Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

    • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
    • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
    • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

    27. AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

    • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
    • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
    • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

    28. Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

    • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
    • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
    • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

    29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

    • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
    • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
    • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

    30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

    • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
    • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
    • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

    Related Post: PharmaShots’ Most Read News of 2019

    The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.

    Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

    Shots:

    • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
    • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
    • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

    Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Money Control

    The post Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine first appeared on PharmaShots.

    Questions hang over UK’s rollout of Oxford/AstraZeneca jab

    Analysis: regulator surprises by approving 12-week gap between first and second shots of vaccine as well as Pfizer/BioNTech shot

    It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in the shortest possible time. The answer that government advisers have come up with is to give them all – more than 20 million of them – a single shot of the Oxford/AstraZeneca vaccine so that they have some protection and postpone the second dose to three months afterwards, when hopefully there will be plenty of vaccine available for boosters.

    Related: How well does the Oxford vaccine work? What we know so far

    Related: The vaccine miracle: how scientists waged the battle against Covid-19

    Continue reading…

    AZ COVID-19 vaccine cleared in UK, dosing to start next week

    The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.

    The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.

    The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.

    The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.

    Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.

    He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”

    The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.

    AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.

    Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”

    He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.

    In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.

    The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.

    Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.

    The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.

    The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.

    The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.

    “It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.

    “We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”

    The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.

    EU orders another 100m doses of Comirnaty

    The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.

    Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.

    The post AZ COVID-19 vaccine cleared in UK, dosing to start next week appeared first on .

    AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

    Shots:

    • The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses administered with an interval of between 4 & 12wks
    • The authorization is based on independent advice from its CHM following a rolling review of trial data that included an interim analysis of the P-III program led by the University of Oxford
    • AstraZeneca aims to supply millions of doses in Q1 as part of an agreement with the government to supply ~100M doses in total. The company will continue the regulatory interactions across the globe for the next approvals

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Express Pharma

    The post AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK first appeared on PharmaShots.

    Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel

    Amazon, AstraZeneca, Pfizer, Merck to Build $10M Digital Health Innovation Lab in Israel
    Rehovot Science Park

    What You Should Know:

    – Pfizer, AstraZeneca, Merck, and Teva, and Amazon Web Services (AWS) has been selected by the Israel Innovation Authority to establish an innovation lab in the fields of digital health and computational biology.

    – The innovation lab located in the Rehovot Science Park will
    receive a government budget of $10M over the next five years and is slated to
    start operations in 2021.


    Pfizer, AstraZeneca, Merck, and Teva, as well as the Israel Biotech Fund and tech giant
    Amazon Web Services (AWS)— to establish an innovation lab in the fields of digital health
    and computational biology. The companies were selected from a competitive bid process
    conducted by the Israel Innovation
    Authority
    together with the National Digital Israel Initiative at the
    National Digital Ministry.

    The group will establish the Lab at the Rehovot Science Park
    and invest in building a wet computational lab infrastructure in order to
    assist early-stage entrepreneurs and startups to meet the challenges of the
    healthcare industry, from the ideation stage to attaining proof of concept. The
    Lab, scheduled to open in 2021, will be joining existing innovation labs as
    part of the Israel Innovation Authority’s Innovation Lab Program.

    $10M Operational Budget Over Next 5 Years

    The innovation lab will operate on a government budget of
    NIS 32 million ($10M USD), as well as additional funding from the partner companies.
    The group will operate over the next five years, during which the Innovation
    Authority, together with the National Digital Ministry, will finance 85% of a
    total NIS 3 million budget for each startup that joins the lab, enabling them
    to reach significant milestones in their technological development. The
    Innovation Authority and National Digital Ministry will also participate in the
    operating costs and in setting up the lab’s infrastructure.

    Innovation Lab Focus Areas

    The purpose of the Lab is to assist in the establishment and advancement of new startups developing innovative AI-based computational technologies aimed at discovering personalized solutions and treatments. The Lab will also help its startups — with the assistance of the lab partners and access they provide to their unique scientific know-how and leading experts — in developing groundbreaking medications and treatments. 

    “This last year proved that the healthcare sector is rapidly transitioning to development and use of advanced technologies integrating engineering and biology, which has already led to more accurate results within a shorter time framework. This lab is part of the ‘Bio-convergence Strategy’ promoted by the Innovation Authority over the last year, aimed at establishing a successful, innovative ecosystem in the healthcare sector, which will serve as a proper basis for establishing innovative companies based on groundbreaking academic research performed in these areas in Israel. The expertise and vast experience of the lab partners will enable these companies to establish a significant, trailblazing industry in Israel,” said Aharon Aharon, CEO of the Innovation Authority.

    Vulnerable should all get COVID-19 shot before summer, says NHS chief

    NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers.

    The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.

    There are around 25 million people classed as vulnerable due to their age or health conditions, and hitting that target will likely rely on the much-anticipated approval of the AstraZeneca/University of Oxford COVID-19 vaccine, said to be coming this week.

    The UK has ordered 100 million doses of the AZ vaccine, which unlike the Pfizer/BioNTech shot can be stored and transported at normal temperatures, making it easier to distribute. Around 40 million doses are due to be delivered before the end of March. A third shot from Moderna isn’t expected to be available in the UK until well into next year.

    The Pfizer/BioNTech vaccine – which was approved by the EU last week – is being delivered via a network of more than 80 hospital hubs and over 500 GP-led vaccination centres, as well as in care homes in the UK.

    That will likely have to be expanded even further if the AZ vaccine is approved and as the immunisation programme gathers pace.

    Stevens’ forecast – delivered to staff at a vacciination centre – came alongside a warning that NHS workers are “back in the eye of the storm”, with the number of coronavirus patients in hospitals higher than at the peak of the first wave.

    There were around 20,500 hospitalised cases as of this morning, above a peak of just under 19,000 as the first wave hit in April. The UK also recorded a record number of lab-confirmed new cases yesterday at more than 41,000, although that figures reflects a higher level of testing nationally.

    At the same time, the new, more transmissible variant of SARS-CoV-2 that was first identified in the UK has been detected in more than 20 other countries around the world, including several EU member states, India, Canada, Japan and Hong Kong.

    The leading vaccine developers have said there is no reason their shots will not work against the new variant.

    So far there is little evidence of “anti-vaxxer” resistance to the vaccine in the UK. However, in Spain – where more than a quarter of people said they would not take the vaccine in a recent survey – the health ministry has suggested it will set up a registry of people who refuse to be vaccinated and share it with other EU members.

    The European Commission has said it expects to deliver 200 million doses of the Pfizer/BioNTech vaccine to EU countries by September 2021.

    Novavax vaccine starts US phase 3

    Meanwhile, another COVID-19 vaccine has entered the late-stage testing phase in North America. US biotech Novavax has started a phase 3 trial of its recombinant protein-based shot NVX-CoV2373 in the US and Mexico, adding to an ongoing phase 3 trial that started in the UK that is due to read out next year.

    The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

    The post Vulnerable should all get COVID-19 shot before summer, says NHS chief appeared first on .

    NHS doctors ‘scrabbling’ to get vaccine amid alarm at Covid variant

    Many medics ‘frustrated’ about low priority given to frontline staff at high risk of infection

    Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised.

    A new survey reveals that almost two-thirds of medics who responded to it have still not had the vaccine, half believe its delivery to the NHS frontline has been “ad hoc” and a third have no idea when they will be offered it. They fear the government’s decision to prioritise over-80s and care home staff above health workers has left them at risk of catching the disease, especially given the emergence of the coronavirus variant, which is 70% more transmissable.

    Continue reading…

    UK scientists trial drug to prevent coronavirus infection leading to disease

    Exclusive: antibody therapy could confer instant immunity against Covid-19 to at-risk groups

    British scientists are trialling a new drug that could prevent someone who has been exposed to coronavirus from going on to develop the disease Covid-19, which experts say could save many lives.

    The antibody therapy would confer instant immunity against the disease and could be given as an emergency treatment to hospital inpatients and care home residents to help contain outbreaks.

    Continue reading…

    PharmaShots Weekly Snapshots (Dec 21-23, 2020)

    Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer

    Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment

    AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy

    Published: Dec 22, 2020 | Tags: AMO Pharma, AMO-02, Initiation, REACH-CDM, Treatment of Congenital Myotonic Dystrophy

    Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

    Published: Dec 22, 2020 | Tags: (dexamethasone ophthalmic insert), Dextenza, Ocular Itching, Ocular Therapeutix, reports, sNDA Submission, Us FDA

    Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

    Published: Dec 21, 2020 | Tags: Autoleucel (cilta-cel), BLA, Initiates, Janssen, Multiple Myeloma, Rolling, Submission, Us FDA

    Voyager Therapeutics Provides Update on NBIB-1817(VY-AADC) Program to Treat Parkinson Disease

    Published: Dec 22, 2020 | Tags: (VY-AADC), NBIB-1817, Parkinson Disease, Provides, Update, Voyager Therapeutics

    Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma

    Published: Dec 22, 2020 | Tags: (daratumumab), DARZALEX, Health Canada Approval, Janssen, Multiple Myeloma, receives, Treatment

    AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

    Published: Dec 22, 2020 | Tags: Asthma, AstraZeneca, Corticosteroid, Dependent, Oral, P-III, patients, reports, results, Severe, SOURCE, Tezepelumab, Trial

    Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

    Published: Dec 21, 2020 | Tags: (BNT162b2), BioNTech, Comirnaty, Conditional Marketing Authorization, COVID-19, EC, Pfizer, receives

    Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS

    Published: Dec 21, 2020 | Tags: (peginterferon beta-1a), Biogen, European Commission, Marketing Authorization, Plegridy, receives, Relapsing-Remitting MS

    Servier to Acquire Agios’ Oncology Business for ~$2B

    Published: Dec 21, 2020 | Tags: $2B, Agios, Agreement, business, Its, Oncology, Royalties, Sell, Servier, Signs

    Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

    Published: Dec 21, 2020 | Tags: Diabetic, Edema, Faricimab, Global, Macular, P-III, reports, results, Roche, Studies, Two

    AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

    Published: Dec 21, 2020 | Tags: (osimertinib), approval, AstraZeneca, Early-Stage, EGFR-mutated Lung Cancer, receives, Tagrisso, US FDA’s

    Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

    Published: Dec 18, 2020 | Tags: Against, COVID-19, EUA, Moderna, mRNA-1273, receives, US, Us FDA

    Ultragenyx Signs a License Agreement with Mereo for Setrusumab in Osteogenesis Imperfecta

    Published: Dec 17, 2020 | Tags: Agreement, Imperfecta, Mereo BioPharma, Osteogenesis, Setrusumab, Signs, Ultragenyx

    ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV

    Published: Dec 21, 2020 | Tags: EC Marketing Authorization, Edurant Receives, HIV-1 Infection, Rekambys, ViiV Healthcare, Vocabria (cabotegravir)

    Philips to Acquire BioTelemetry for ~$2.8B

    Published: Dec 18, 2020 | Tags: Acquires, BioTelemetry, Philips

    Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

    Published: Dec 18, 2020 | Tags: Agreement, Candidates, Develop, Drug, Engager, Immuno, Janux Therapeutics, Merck, Novel, Oncology, Signs, T Cell, technology, Using

    GSK Signs a License Agreement with Sosei Heptares Targeting Immune Disorders of the Digestive System

    Published: Dec 21, 2020 | Tags: Digestive System, Global License Agreement, GPR35, GSK, Immune Disorders, Signs, Sosei Heptares

    Related News: PharmaShots Weekly Snapshots (Dec 14-18, 2020)

    The post PharmaShots Weekly Snapshots (Dec 21-23, 2020) first appeared on PharmaShots.

    UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

    The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days.

    If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian “Tier 4” restrictions due to the emergence of as more infectious variant.

    Latest figures show that there were nearly 40,000 cases recorded yesterday, the highest since mass testing began, although it’s thought infection rates were higher during the first wave of the virus in spring when tests were not readily available.

    The Medicines and Healthcare products Regulatory Agency (MHRA) began a fast-track rolling review of the vaccine in November and reports point towards a decision between Christmas and New Year.

    The UK has ordered 100 million doses of the vaccine, which is based on an adenovirus vector and is easy to handle than rivals from Pfizer/BioNTech and Moderna.

    AZ’s vaccine, dubbed AZD1222, is stored at normal refrigerator temperatures while the Pfizer/BioNTech and Moderna shots need to be kept at around -70C and -20C respectively to maintain the integrity of their RNA structure.

    According to health secretary Matt Hancock, the full dossier of trial evidence is now with the regulator, which is poised to make a decision in the coming days.

    AZ’s vaccine is safe and effective, according to the data publicly available so far, although it seems that giving a half-dose shot first following a second full dose is more effective.

    Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

    With two full doses, efficacy is around 62%, according to findings released towards the end of last month based on data from nearly 9,000 patients in the UK and Brazil.

    Efficacy rose to around 90% in just over 2,700 patients given the low dose-high dose formulation, which was stumbled on by mistake because of a manufacturing error.

    Quite what the MHRA will make of this is not clear, nor is it known whether the regulator has more up-to-date figures than those announced at the end of November.

    Professor Sir John Bell, the government’s life sciences tsar and Regius Chair of Medicine at the University of Oxford, told BBC Radio 4’s Today programme yesterday:  “We are getting to be about prime time now.

    “I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.

    “And I have no concerns whatsoever, the data looks better than ever.”

    The post UK prepares for decision on AZ/Oxford vaccine as COVID cases soar appeared first on .

    NICE backs AZ’s Forxiga for heart failure

    Just a few weeks after its EU approval for heart failure, AstraZeneca’s Forxiga has been backed by NICE for this use by the NHS in England and Wales.

    Forxiga (dapagliflozin) – originally developed as a type 2 diabetes drug – is the first SGLT2 inhibitor to be approved for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without diabetes.

    It got a green light for this use in the EU in early November and in the US in May, with the new indication helping to drive third-quarter sales up by a third to $525 million.

    Approval for Farxiga was based on positive results from the phase 3 DAPA-HF trial, which showed Farxiga achieved a statistically significant and clinically meaningful 26% reduction of death or hospitalisation for heart failure compared with placebo.

    Today, NICE issued draft guidance which recommends Forxiga as an option for treating symptomatic HFrEF in adults if used as an add-on to standard drugs, which would make around 260,000 additional people eligible for treatment with the drug.

    Novartis’ Entresto (sacubitril/valsartan) is also used to treat HFrEF, an indication which propelled it to sales of almost $2 billion last year.

    According to NICE, while there are no head-to-head trials comparing Entresto and Forxiga, AZ’s drug “is likely to be as effective as [Entresto] at reducing the risk of death from heart disease

    AZ’s rivals Eli Lilly and Boehringer Ingelheim meanwhile are also attempting to develop their SGLT2 inhibitor Jardiance (empagliflozin) for heart failure. They suffered a setback a year ago when the drug failed to improve exercise ability in two phase 3 studies, but bounced back with the results of the EMPEROR-Reduced study in July.

    GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population. It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF in 2021.

    AZ is also putting Forxiga through its paces in heart failure in combination with other drugs, including its mineralocorticoid receptor modulator AZD9977 and selective endothelin A antagonist zibotentan (also known as AZD4054), with mid-stage trials on the go.

    Meanwhile, heart failure is just one area into which AZ is hoping to expand Forxiga before its patents start to expire in the coming years. It’s also looking at chronic kidney disease (CKD), and has picked up a breakthrough designation from the FDA for this indication.

    Forxiga was the first medicine to significantly prolong survival in patients with CKD, either with or without diabetes, in the DAPA-CKD trial.

    The post NICE backs AZ’s Forxiga for heart failure appeared first on .

    AMA Adds 3 Additional CPT Codes for AstraZeneca’s COVID-19 Vaccine

    AMA Adds 3 Additional CPT Codes for AstraZeneca's COVID-19 Vaccine

    What You Should Know:

    – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine.


    The American Medical Association (AMA) today announced that
    the Current Procedural Terminology (CPT®) code set is
    being updated by the CPT Editorial Panel to include immunization and
    administration codes that are unique to the COVID-19 vaccine under development
    by AstraZeneca and University of Oxford.

    The new CPT codes will be effective for use on the condition
    that the AstraZeneca vaccine receives approval or emergency use authorizations
    from the Food and Drug Administration (FDA). The AMA is publishing the new CPT
    codes now to ensure electronic systems across the U.S. health care
    system are updated and prepared for the prospect of FDA approval or
    authorization for the AstraZeneca vaccine.

    Growing List
    of CPT Codes to Support COVID-19 Vaccines

    The AstraZeneca vaccine joins two other COVID-19 vaccines that were previously issued unique CPT codes to report vaccine-specific immunizations once FDA approval or authorization has been granted. On Nov. 10, the AMA announced that COVID-19 vaccines developed by Pfizer and Moderna had been issued unique CPT codes to clinically distinguish each vaccine for better tracking, reporting, and analysis that supports data-driven planning and allocation

    AstraZeneca COVID-19 Vaccine CPT Codes Overview

    The new
    Category I CPT code and long descriptor for the AstraZeneca vaccine are:

    91302: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage, for intramuscular use

    In addition to the new vaccine-specific product CPT code, the AstraZeneca vaccine has been issued vaccine administration CPT codes that are distinct to its two-dose immunization schedule. These CPT codes report the actual work of administering the vaccine, in addition to all necessary counseling provided to patients or caregivers and updating the electronic record.

    For quick reference, the new vaccine administration CPT codes and long descriptors for the AstraZeneca vaccine are:

    0021A: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, DNA, spike protein, chimpanzee adenovirus Oxford 1 (ChAdOx1) vector, preservative-free, 5×1010 viral particles/0.5mL dosage; first dose 

    0022A: second dose

    In addition to the long descriptors, short and medium descriptors for all the new vaccine-specific CPT codes can be accessed on the AMA website, along with several other recent modifications to the CPT code set that have helped streamline the public health response to the SAR-CoV-2 virus and the COVID-19 disease.

    “A mass vaccination effort with the first available COVID-19 vaccines presents enormous logistical challenges,” said AMA President Susan R. Bailey, M.D. “The ability to correlate each COVID-19 vaccine with its own unique CPT code provides analytical and tracking advantages that ensures optimal vaccine distribution and administration, especially for patients who will need to complete the two-dose immunization schedule.”


    AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial

    AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme.

    The new study – called SOURCE – was supposed to back up the encouraging readouts from the phase 3 NAVIGATOR trial and phase 2b PATHWAY, which found that the antibody benefited asthma patients whose symptoms were so bad they needed oral corticosteroid (OCS) therapy.

    SOURCE has changed the script however by missing its primary objective, proving unable to significantly reduce the daily dose of OCS needed by patients in the 150-subject trial, although AZ and Amgen still think the drug is approvable based on the “totality of evidence”.

    AZ and Amgen have only released the top-line data, so it could be a while before an explanation for the failure emerges, although AZ’s head of biopharmaceuticals R&D Mene Pangalos suggested it may have resulted from flaws in the trial design.

    Just a month ago, AZ and Amgen trumpeted the result of the NAVIGATOR trial of tezepelumab, a first-in-class inhibitor of the cytokine thymic stromal lymphopoietin (TSLP) that analysts have said could have blockbuster potential if approved, perhaps reaching as much as $2.5 billion in annual sales.

    NAVIGATOR found that the antibody reduced the asthma exacerbations compared to placebo when added to standard care, and crucially also seemed to have a positive impact on patients with low levels of white blood cells called eosinophils.

    Biologics like GlaxoSmithKline’s Nucala (mepolizumab) and AZ’s Fasenra (benralizumab) – both IL-5 inhibitors – and Sanofi/Regeneron’s IL-4 and IL-13 blocker Dupixent (dupilumab) are already approved to treat severe eosinophilic asthma but treatment options are limited for patients with non-eosinophilic forms.

    Tezepelumab claimed a breakthrough designation in non-eosinophilic asthma from the FDA in 2018, on the promise that it could provide an option for these patients, who account for around a third of all severe asthma cases.

    The drug acts further upstream in the inflammatory cascade than its rivals and so could be effective for a broader range of patients, according to its developers.

    AZ and Amgen say they still plan to press ahead with plans for regulatory filings for tezepelumab next year, and will prevent detailed results from NAVIGATOR and SOURCE at a future medical conference.

    The two partners started working together on tezepelumab in 2012, and was one of five drugs covered by that alliance. It has previously failed a mid-stage study in atopic dermatitis, but is still in development for that indication as well as chronic obstructive pulmonary disease (COPD).

    The post AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial appeared first on .

    AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

    Shots:

    • The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks.
    • The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma control, the safety profile was consistent with previous trials. The therapy’s other efficacy parameters were similar to those observed in previous trials, including the P-III NAVIGATOR trial
    • Tezepelumab is a human mAb targeting TSLP, being developed in collaboration with AstraZeneca and Amgen

    Click here ­to­ read full press release/ article | Ref: AstraZeneca  | Image: Physicians Practice

    The post AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma first appeared on PharmaShots.

    AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

    Shots:

    • The approval is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated
    • Results: reduction in the risk of disease recurrence (83%); DFS results in the overall trial population in reducing the risk of disease recurrence (80%); @2 yrs. disease-free and alive patients (89% vs 52%)
    • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases and has received the US FDA BTD for patients in the early-stage disease setting. The therapy is under PR in China and regulatory review in the EU

    Click here ­to­ read full press release/ article | Ref: BusinessWire  | Image: Marketwatch

    The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.

    AZ’s Tagrisso gets new early lung cancer use in US

    AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA in a new lung cancer indication that extends its use to a group of patients with early-stage disease.

    The new use covers adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after a potentially curative operation.

    Patients must be tested to for the presence of the mutation to check they are eligible to receive the oral drug.

    Up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery.

    But disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.

    Based on the findings of the phase 3 ADAURA study this could change, as Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in a primary analysis of patients with Stage II and Stage IIIa NSCLC with EGFR mutations.

    This was also seen in the overall trial population of patients with Stage 1B-IIIA disease, the secondary endpoint of the trial.

    Findings showed that Tagrisso cut the risk of disease recurrence by 83% compared with placebo in the trial that was stopped early because of the high efficacy shown in the treatment arm.

    The ADAURA results were showcased as the last set presentation at this year’s virtual American Society of Clinical Oncology conference, rather like the headline performer at a rock festival.

    Results dazzled the oncologists who described the findings as a “home run” and the new indication will also have beneficial side-effect on AZ’s finances, adding substantially to the blockbuster revenues already generated by Tagrisso.

    The results also suggest further uses for the drug in early disease and more revenues to come from one of the company’s biggest success stories from the last decade.

    Tagrisso was first approved in 2015 to counter a single amino acid mutation known as T790M that nearly always occurs after about 10 months of treatment with tyrosine kinase inhibitor drugs, making tumours resistant.

    But after approval in later stage disease, AZ found that the drug outperforms rival tyrosine kinase inhibitors as a first-line treatment in the FLAURA trial, leading to a second FDA indication two years ago.

    Tagrisso is already a blockbuster bringing in revenues of more than $3.1 billion in the first nine months of this year, and the new indication will add further momentum to AZ’s biggest selling drug.

     

    The post AZ’s Tagrisso gets new early lung cancer use in US appeared first on .

    FDA gives nod to Moderna vaccine for Covid-19

    The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

    PharmaShots Weekly Snapshots (Dec 14-18, 2020)

    Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

    Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz

    Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

    Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, Us FDA

    NOWDiagnostics Receives CE Mark for its ADEXUSDx COVID-19 Antibody Fingerstick Test

    Published: Dec 17, 2020 | Tags: ADEXUSDx COVID-19, Antibody Fingerstick Test, COVID-19, Launches, NOWDiagnostics

    GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

    Published: Dec 17, 2020 | Tags: (belimumab), Active, Benlysta, GSK, Lupus Nephritis (LN), Recieves, US, US FDA’s Approval

    GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

    Published: Dec 17, 2020 | Tags: Commercialize, Develop, Exclusive License Agreement, GSK, Signs, SRF813, Surface Oncology

    Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

    Published: Dec 17, 2020 | Tags: Advisory, Against, Committee, COVID-19, EUA, Moderna, receives, Supporting, US, Us FDA, vaccine, Vote

    Novartis to Acquire Cadent Therapeutics for ~$770M

    Published: Dec 17, 2020 | Tags: $770M, Acquire, Cadent, Novartis, therapeutics

    Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

    Published: Dec 16, 2020 | Tags: (KTE-X19), EC’s Conditional Marketing Authorization, Europe, Kite, receives, Relapsed or Refractory Mantle Cell Lymphoma, Tecartus, ZUMA-2 Study

    Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

    Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA

    Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

    Published: Dec 16, 2020 | Tags: approval, Health Canada, Novartis, One-Time Gene Therapy, receives, Spinal Muscular Atrophy (SMA), Zolgensma

    Novo Nordisk to Initiate a P-lll Study of Semaglutide to Treat Alzheimer Disease

    Published: Dec 16, 2020 | Tags:  Alzheimer Disease, Novo Nordisk, P-lll Development, Semaglutide, Start

    Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

    Published: Dec 15, 2020 | Tags: Advisory, Committee, Entresto, HFpEF, Novartis, patients, Positive, receives, Recommendation, Treat, USFDA

    Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

    Published: Dec 15, 2020 | Tags: Abbott, antibody, Blood, CE Mark, COVID-19, IgG, Quantitative, receives, Test

    Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

    Published: Dec 15, 2020 | Tags: Antigen, COVID-19, Ellume, EUA, receives, Test, Us FDA

    Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

    Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration

    Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

    Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance

    Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

    Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval

    Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

    Published: Dec 15, 2020 | Tags: Agreement, Commercialization, Development, Filgotinib, Galapagos, Gilead, Jyseleca, Signs

    Lilly to Acquire Prevail Therapeutics for ~$1.04B

    Published: Dec 15, 2020 | Tags: ~$1.04B, Acquire, Lilly, Prevail Therapeutics

    EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

    Published: Dec 15, 2020 | Tags: approval, AstraZeneca, CHMP, EU, Imfinzi, NSCLC, Recommended, Unresectable

    CureVac Commences P-llb/lll Trial of CVnCoV for COVID-19

    Published: Dec 14, 2020 | Tags: Commences, COVID-19, CureVac, CVnCoV, P-llb/lll Trial

    Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

    Published: Dec 15, 2020 | Tags: Advanced, breast, Cancer, Cobas, Launch, Metastatic, Mutation, patients, PIK3CA, Roche, Test

    Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

    Published: Dec 14, 2020 | Tags: (Denosumab), Initiates, P-Ill Study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

    Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

    Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License

    Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

    Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA

    Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

    Published: Dec 11, 2020 | Tags: approval, AstraZeneca, breast, Cancer, CHMP, Daiichi Sankyo, Deruxtecan, EU, HER2, Metastatic, Positive, Recommended, trastuzumab

    Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

    Published: Dec 14, 2020 | Tags: COVID-19, Novartis, P-lll, reports, results, RUXCOVID Study, ruxolitinib

    AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

    Published: Dec 14, 2020 | Tags: AstraZeneca’s, China, EU’s Approval, Japan, moderate to severe chronic obstructive pulmonary disease (COPD), receives, Trixeo Aerosphere, US

    Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

    Published: Dec 10, 2020 | Tags: Agreement, Alvotech, Biosimilar, Commercialization, Extends, Four, Fuji Pharma, Japan, Medicines

    Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

    Date: Dec 11, 2020 | Tags: BioNTech, BLA, BNT162b2, COVID-19, EUA, files, Pfizer, Prevent, receives, Us FDA

    AstraZeneca to Acquire Alexion for $39B

    Published: Dec 12, 2020 | Tags: $39B, Acquires, Alexion, AstraZeneca

    Related News: PharmaShots Weekly Snapshots (Dec 7-11, 2020)

    The post PharmaShots Weekly Snapshots (Dec 14-18, 2020) first appeared on PharmaShots.

    MacroGenics’ HER2 breast cancer drug Margenza approved in US

    MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease.

    Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of therapy.

    One of the talking points at the American Society of Clinical Oncology (ASCO) in 2019, Margenza is a tweaked version of Roche’s Herceptin (trastuzumab), which dominated the HER2-mutated breast cancer market for years until the recent launch of cut-price biosimilar competitors.

    MacroGenics has altered the “Fc” part of the antibody – the tail of the ‘Y’-shaped molecule – so that it interacts more efficiently with the immune system when engaged with a cancer cell.

    This has produced a small but significant benefit in progression-free survival, with the phase 3 SOPHIA study showing a 24% reduction in the risk of disease progression or death with Margenza plus chemotherapy, compared with trastuzumab plus chemo.

    The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy.

    The difference was more marked in patients carrying a genetic variation called CD16A 158F, where PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months).

    Response rate was also improved with the Margenza regimen at 22%, compared with 16% in those treated with the Herceptin regimen.

    A final overall survival analysis is expected in the second half of 2021, after a planned launch in March next year.

    No price has been officially decided but the company said it plans to price it at the low end of the price range seen in other HER2 metastatic breast cancer therapies.

    Those competing therapies include Seagen’s Tukysa (tucatinib), which was approved in May for advanced HER2-positive disease in combination with trastuzumab and capecitabine after treatment with at least one HER2-targeted drug.

    AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) was approved a year ago for HER2-positive breast cancer after two or more previous HER2 regimens and Puma’s Nerlynx (neratinib) is another FDA-backed option in this indication.

    The post MacroGenics’ HER2 breast cancer drug Margenza approved in US appeared first on .

    Hospitals sue drug companies over discount program

    The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.

    Tensions mount over handling of UK Covid vaccine rollout

    With overall costs for vaccinating the UK population at £12bn, the public accounts committee flags ‘highly unusual’ arrangements

    Vaccinating the population against Covid-19 will cost up to £12bn, Whitehall’s spending watchdog has disclosed, amid details of tensions between health bodies over the rollout.

    The National Audit Office said the government would spend up to £11.7bn on purchasing and manufacturing Covid-19 jabs for the UK before deploying them in England.

    Related: Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

    Related: Kate Bingham: well-connected but under-fire UK vaccines chief

    Continue reading…

    EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

    Shots:

    • AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT
    • The CHMP opinion is based on P-III PACIFIC trial that supported the 2wk, weight-based dosing of 10mg/kg q2w already approved in LA, unresectable NSCLC & the P-III CASPIAN trial which used fd, q4w during maintenance treatment in ES-SCLC
    • The option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: EORTC

    The post EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC first appeared on PharmaShots.

    FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

    Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist

    Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its commercialization in the market.

    At present, there are no approved therapies for NASH. The present NASH treatment market is dominated and supported by off-label therapies. DelveInsight estimated that the coming future for NASH market is expected to experience entry of more such off-label therapies unless an approved cure arrives.

    The US FDA decision to grant FTA to ASC42 depicts the potential of the therapy in addressing the unmet medical needs for NASH patients. ASC42 is an oral fatty acid synthase (FASN) inhibitor that has managed to significantly reduce the liver fat in Phase II clinical trial (FASCINATE-1).

    Gannex has two additional drug candidates as well that are at the clinical stage in its NASH pipeline, ASC40 and ASC41.

    Incyte’s Ruxolitinib failed to meet Primary Endpoint in the Phase 3 RUXCOVID Study for COVID-19 Associated Cytokine Storm

    Incyte announced the results from the Phase III RUXCOVID study investigating the safety and efficacy of ruxolitinib (Jakafi®) for patients 12 years and older with COVID-19 associated cytokine storms.

    Ruxolitinib is an orally administered inhibitor of the JAK 1 and JAK 2 tyrosine kinases. The Phase III RUXCOVID study tested ruxolitinib on top of standard of care or SoC therapy compared to SoC treatment alone in patients with COVID-19.

    The initial data from the trial demonstrated no statistically significant reduction in the number of hospitalized COVID-19 patients receiving ruxolitinib plus SoC therapy who experienced severe complications including death, mechanical ventilation or ICU care by Day 29, compared to SoC treatment alone.

    The drug, Ruxolitinib, is commercialized by Incyte in the US; and is licensed to Novartis outside the U.S. Sold under the name Jakafi, it is FDA-approved for the treatment of polycythemia vera (PV) in adults.

    Pfizer, BioNTech COVID-19 Vaccine rolls out in a watershed moment

    In a historic first, the US FDA issued an Emergency Use Authorization (EUA) to the COVID-19 mRNA, BNT162b2, vaccine candidate for COVID-19 of Pfizer-BioNTech. The duo plans to accumulate additional data and file for Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

    COVID-19 still continues to ravage human society turning the economy upside down. And, the EUA is a pivotal move in the quest to turn back things to normal. The vaccine is the first-ever mRNA vaccine to get to the EUA and is developed in record-time low.

    The decision of the regulatory agency was based on the results from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine. The data depicted the efficacy rate of the vaccine of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

    The U.K. was the first to give its nod to the vaccine followed by Bahrain, Canada, Saudi Arabia and now, the U.S.

    In a rare move for rare portfolio, AstraZeneca buys Alexion for USD 39B cash/stock deal

    AstraZeneca is ready to dish-out USD 39 Billion to acquire rare disease stalwart Alexion. It seems a global oncology performer, AZ is now taking interest in the rare disease landscape.

    Not long ago, another pharma titan, Gilead acquired Immunomedics by shelling-out USD 21 Billion in one of the most expensive and bold moves. However, AstraZeneca has outwon Gilead with even a large one with a prime focus on rare disease portfolio.

    After the acquisition, the companies plan to strengthen a spectrum of domains, technologies, and therapeutic areas to bring innovative therapies to people. The duo will also have an expanded coverage across primary, speciality and highly specialised care and increased geographical reach.

    The combined entity will put forward two rapidly converging, patient-centric models of care delivery with combined strengths in immunology, biologics, genomics and oligonucleotides to drive future medicine innovation

    Welcome the new entrant in Gene therapy market: InnoSkel

    Elvire Gouze, a scientist, entrepreneur, and an expert in skeletal disorders, has come up with another startup company, InnoSkel, with an aim to move forward in developing innovative gene therapy platform for a wide variety of life-threatening skeletal diseases.

    The company is officially launched with €20 million ($24 million) in first-round financing led by Jeito Capital alongside Vida Ventures and the Turenne Group to advance the platform. InnoSkel is Jeito’s third investment in the past four months, after SparingVision and Neogene.

    Earlier the scientist has sold her first biotech, Therachon, to Pfizer for a hefty USD 810 million. In similar lines with Therachon, InnoSkel is also committed to focusing on diseases that cause dwarfism, however, this time the approach towards treatment is different.

    The proceeds from the financing are expected to be consumed in advancing InnoSkel’s asset pipeline from its dedicated gene therapy platform, including a group of rare and life-threatening skeletal disorders collectively known as type 2 collagenopathies, the most severe being, a neonatal presenting skeletal disorder called Spondyloepiphyseal Dysplasia congenita (SEDc).

    The post FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel appeared first on DelveInsight Business Research.

    Ministers would be wise to play for time before ordering Sizewell C | Nils Pratley

    Dashing ahead with a nuclear power station that’s modelled on Hinkley Point C would be reckless

    This is the government’s problem as it reopens talks on a proposed nuclear power station at Sizewell C in Suffolk: it is contemplating ordering a replica of Hinkley Point C before the Somerset original has produced a single megawatt of electricity.

    That is not a small point. Developer EDF’s pre-Hinkley version of its European pressurised reactor at Flamanville in Normandy is about a decade behind schedule. What’s more, EDF wants UK taxpayers or bill-payers to bear more of the construction risks at Sizewell, a less-than-compelling offer when you remember that Flamanville is also €9bn (£8.2bn) over budget.

    Continue reading…

    AstraZeneca shares slump after it agrees $39bn Alexion buyout

    Britain’s biggest drugmaker offers 45% premium for shares of US rare diseases specialist

    AstraZeneca shares fell sharply after it agreed to a $39bn (£29bn) takeover of the US rare diseases specialist Alexion, the biggest deal in its history if it goes ahead.

    Investors sold off shares in the Anglo-Swedish drugmaker over fears it was paying too much for Alexion in the stock-and-shares deal. The offer price of $175 a share represents a 45% premium on Alexion’s closing price before the deal was announced. To finance the deal, AstraZeneca has secured a $17.5bn bridging loan.

    Continue reading…

    Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

    Shots:

    • The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine
    • The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with the P-I trial
    • EC will review the CHMP’s positive opinion to grant MAA for the therapy in the EU. Trastuzumab deruxtecan is a HER2 directed ADC

    Click here ­to­ read full press release/ article | Ref: Business wire | Image: GlassDoor

    The post Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer first appeared on PharmaShots.

    Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancer

    Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster.

    At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients with unresectable or metastatic HER2-positive breast cancer, who have been previously treated with other anti-HER2 drugs.

    Enhertu has already been approved for third-line use in HER2-positive breast cancer in the US at the end of 2019 and in Japan earlier this year, based on the results of the phase 2 DESTINY-Breast01 trial in 184 patients, which revealed that the drug shrank tumours in 61% of recipients.

    Revenues from the drug  in the first nine months of 2020 came in at $136 million – including $60 million in the third quarter.

    Sales were recorded by Daiichi Sankyo, with AZ pocketing $63 million in profit sharing, and according to AZ the drug is now the most prescribed medicine in the third-line and fourth-line settings of HER2-positive metastatic breast cancer.

    Enhertu consists of the antibody used in Roche’s blockbuster HER2 antibody Herceptin (trastuzumab), linked to a topoisomerase inhibitor that is toxic to cancer cells. Around one in five patients with breast cancer are considered HER2 positive, which is associated with aggressive disease, a high recurrence rate, and an increased risk of dying.

    It works by latching on to HER2-positive cancer cells and delivering a payload to kill them, while ignoring healthy cells, in patients who have failed to respond to Roche’s HER2-targeting cancer drugs Herceptin, Perjeta (pertuzumab), and ADC Kadcyla (trastuzumab emtansine).

    Kadcyla was once tipped to become the go-to treatment HER2-posiitve breast cancer when first line drugs like Herceptin/Perjeta had failed, but failed to meet the mark in pivotal trials, truncating its sales growth although it still managed to break into the $1 billion-plus bracket.

    Daiichi Sankyo is confident Enhertu can top Roche’s ADC, and also expand the use of HER2 drugs into new cancers like HER2-positive gastric cancer – an indication that is under review by the FDA with a verdict due early next year – and HER2-positive non-small cell lung cancer (NSCLC).

    The intention is to gradually position the drug for earlier-line use in breast, gastric and lung cancer, and eventually to try to expand its use into certain low HER2-expressing tumours.

    If all the pieces fall into place it reckons peak sales could reach $4.5 billion, and there are plenty of analysts predicting that the drug could quickly breach the $2 billion-a-year threshold.

    AZ’s confidence in the potential of Enhertu is evidence from the terms of its late 2019 licensing deal with Daiichi Sankyo, which included a hefty $1.35 billion upfronting a deal that could be worth up to $6.9 billion if all the ADC’s development and sales objectives are achieved.

    The post Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancer appeared first on .

    AstraZeneca to Acquire Alexion for $39B

    Shots:

    • Alexion to receive $60M in cash and 2.1243 ADSs (each ADS represents ½ ordinary share of AstraZeneca) for each Alexion share. The deal values Alexion at $175/ share with a 45% premium to the closing price on Dec 11, 2020
    • Alexion will own ~15% of the combined company. The acquisition will bolster AstraZeneca’s footprints in rare disease and enhance its presence in immunology
    • The duo will work together to build Alexion’s pipeline of 11 molecules across 20+ clinical- programs in rare diseases and beyond. The new company will lead to a WW expansion of Alexion’s portfolio and is expected to deliver double-digit average annual revenue growth through 2025

    Click here ­to­ read full press release/ article | Ref: Businesswire | Image: San Diego Business Attorney

    The post AstraZeneca to Acquire Alexion for B first appeared on PharmaShots.

    Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table

    Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.

    The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.

    The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.

    Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.

    Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.

    It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

    Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

    The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.

    While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.

    In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.

    Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

    Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.

    Meanwhile, AZ will also picks up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.

    AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.

    Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.

    Along with  new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.

    That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).

    “Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.

    “This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”

    The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.

    The post Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table appeared first on .

    Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table

    Alexion has routinely featured among lists of top biopharma takeover prospects in the last couple of years, and that was a good call – AstraZeneca has just swooped in with $39 billion cash-and-stock takeover offer.

    The deal – the largest in the pharma sector since the start of the pandemic – bolsters AZ’s immunology franchise with $4 billion blockbuster Soliris (eculizumab) and longer acting follow-up Ultomiris (ravulizumab), plus a pipeline of 11 drugs for rare and autoimmune diseases.

    The transaction values Alexion at $175 per share, a sizeable 45% premium on its closing price on Friday, the day before the deal was announced.

    Alexion shareholders will receive $60 in cash, plus 2.12 of AZ’s US-listed shares for each share they hold, ending up owning around 15% of the combined company.

    Analysts at SVB Leerink said that while the offer is fair at that price, Alexion is a “scarce and high-quality asset,” which could prompt an offer from another company. In the past, Novartis, Roche, Pfizer and Amgen have all been mentioned as potential suitors.

    It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

    Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

    The threat of biosimilar competition to its cash cow has weakened Alexion’s share price, providing an opportunity for AZ, which has been rumoured to be angling for a large acquisition for several months.

    While the first biosimilars to Soliris have already reached the market in some countries like Russia, Alexion cut a settlement deal with Amgen in the summer that prevents the latter’s biosimilar version of Soliris from entering the US market until 2025, avoiding a near-term cash cliff.

    In the meantime, Ultomiris has been gathering momentum, fuelled by intravenous dosing every eight weeks, rather than every two weeks with Soliris. It racked up $340 million in sales last year, and added another $763 million in the first nine months of this year, backing up its blockbuster credentials.

    Soliris was the first drug to become available for each of its approved indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

    Ultomiris is already approved for PNH and aHUS and in late-stage development for NMOSD, which could lend further momentum.

    Meanwhile, AZ will also picks up three other drugs – Strensiq (asfotase alfa) for hypophosphatasia, Kanuma (sebelipase alfa) for lysosomal acid lipase deficiency (LAL-D) and anticoagulant reversal agent Andexxa (andexanet alfa) – that collectively brought in almost $675 million in the first nine months of 2020.

    AZ is taking on debt to fund the deal but should pay that off quickly given Alexion should book double-digit growth in the coming years, which could be enhanced by AZ’s broader footprint in Europe and Asia.

    Alexion has been working hard to flesh out is pipeline as well, snapping up Achillion Pharma, Syntimmune, Wilson Therapeutics and Portola and forging an alliance with gene-silencing specialist Dicerna focusing on complement diseases.

    Along with  new indications for its existing drugs, the Swiss biopharma has four more drugs in phase 3 development that could benefit from the increased financial and development muscle that AZ will bring to the table.

    That includes ALXN1840 for genetic disorder Wilson disease, with results due in the first half of next year, as well as CAEL-101 for light chain amyloidosis, AG10 for ATTR cardiomyopathy and ALXN2040 or PNH patients with extravascular haemolysis (EVH).

    “Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AZ’s chief executive Pascal Soriot.

    “This acquisition allows us to enhance our presence in immunology,” he added. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.”

    The combined company will be able to carve around $500 million a year off its cost base, and will deliver double-digit growth average annual revenue growth through 2025, providing cash flow to reinvest in R&D, said the two companies in a statement.

    The post Alexion finally has a buyer – and it’s AstraZeneca with $39bn on the table appeared first on .

    PharmaShots Weekly Snapshots (Dec 7-11, 2020)

    Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

    Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

    Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

    Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

    Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

    Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

    Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

    Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

    Gilead to Acquire MYR for ~$1.4B

    Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

    Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

    Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

    Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

    Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

    Google Launches Health Research App Focusing on Respiratory Illnesses

    Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

    Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

    Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

    Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

    Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

    Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

    Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

    Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

    Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

    Elsevier Acquires Shadow Health

    Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

    Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

    Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

    Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

    Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

    Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

    Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

    AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

    Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

    Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

    Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

    RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

    Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

    Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

    Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

    Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

    Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

    Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

    Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

    Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

    Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

    AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

    Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

    Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

    Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

    Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

    Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

    AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

    Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

    Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

    Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

    Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

    Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

    Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

    Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

    Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

    The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

    Covid vaccines: US regulator sceptical over AstraZeneca model

    Vaccine developed in Oxford criticised by FDA with efficacy rates and trials delaying official take-up

    For a man presenting landmark results from trials of a vaccine that it is hoped will save the world from a devastating pandemic, Sir Menelas Pangalos did not look cheerful on Wednesday.

    Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca, and his colleagues are undoubtedly exhausted, having been working round the clock on the coronavirus vaccine with Oxford University since April. But they are now dealing with a sizeable new headache – the doubts of the US regulator.

    Continue reading…

    CLL patients in England to get AZ’s Calquence after okay from NICE

    NHS England is to grant immediate access to AstraZeneca’s cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it in first draft recommendations.

    NICE recommended regular NHS funding for Calquence in CLL who are considered high-risk due to 17p deletion or TP53 mutations.

    It is also recommended for adults with CLL who have had at least one previous treatment and only if AbbVie and Janssen’s class rival Imbruvica (ibrutinib) is their only suitable treatment option.

    NHS England is granting access via an interim funding arrangement with AstraZeneca, which will end 30 days after publication of positive final guidance, after which treatment will be funded by routine commissioning budgets.

    However the guidance has rejected Calquence for a third group of patients with untreated, non-high risk CLL who are unsuitable for treatment with chemotherapy.

    AZ said it will provide further data analyses for continued discussions with NICE about this group of patients.

    Calquence was approved in CLL by the EMA last month as monotherapy or in combination with Roche’s Gazyvaro (obinutuzumab).

    In CLL, too many blood stem cells in the bone marrow become abnormal white blood cells, and these have difficulty in fighting infections.

    As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.

    B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the essential growth pathways for CLL.

    In B-cells, BTK signalling results in the activation of pathways necessary for growth: proliferation, trafficking, chemotaxis, and adhesion.

    Calquence binds selectively to BTK, inhibiting its activity.

    This is the second recommendation of a therapy for CLL in the space of a month – in November it recommended AbbVie/Roche’s chemotherapy-free option of Venclyxto (venetoclax) and Gazyva.

    NICE’s decision allows for a 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.

    The post CLL patients in England to get AZ’s Calquence after okay from NICE appeared first on .

    Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps

    Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck.

    The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention.

    In severe cases, polyps recur, so patients have to undergo multiple operations that according to GSK progressively become less effective and more risky.

    The anti-IL-5 antibody is already approved by the FDA for severe asthma and two other conditions – hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis – and is one of GSK’s top growth products with sales rising 28% to more than $930 million in the first nine months of this year.

    If approved, it will be the first biologic challenger to Dupixent (dupilumab) – which has a different mechanism of action targeting IL-4 and IL-13 – and would also keep Nucala ahead of IL-5 class rivals like Teva’s Cinqair (reslizumab) and AstraZeneca’s Fasenra (benralizumab) that are challenging it in asthma.

    The FDA’s review centres on the SYNAPSE trial, which involved 400 patients with a history of previous surgery who were in need of another procedure due to growing polyps and severe symptoms.

    The drug improved both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52, compared to placebo when added to standard of care, and extended the time to surgery by 57%.

    Standard care for CRSwNP consists of corticosteroids in the nose, after surgery and systemic corticosteroids, but these often lack efficacy.

    AZ reported positive results with Fasenra in CRSwNP in September, so may not be far behind with its own regulatory filings, and has also started to catch up with first-to-market Nucala in sales terms, growing 34% to $666 million in the first three quarters of 2020.

    Regeneron meanwhile said last month that CRSwNP has been helping to drive increased sales of Dupixent, with a “strong uptick” in prescribing for this indication this year as well as a good performance in other uses like atopic dermatitis that drive it to more than $1.1 billion in global sales in the third quarter alone.

    The post Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps appeared first on .

    Nine out of 10 in poor nations to miss out on inoculation as west buys up Covid vaccines

    Billions unlikely to get jabs as rich countries secure 53% of most promising vaccines

    Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said.

    As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.

    Continue reading…

    The vaccine miracle: how scientists waged the battle against Covid-19

    We trace the extraordinary research effort, from the discovery of the virus’s structure to the start of inoculations this week

    In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread?

    Related: ‘I worked so hard in the lab. I cried when the news came’

    What Zhang did was critical … Without the information he provided no one could have started working on vaccines

    Related: Team behind Oxford Covid jab start final stage of malaria vaccine trials

    Related: NHS staff no longer at front of queue for Covid vaccine after rethink

    Continue reading…

    Covid vaccines offer chance for big pharma to improve its image

    They make life-saving medicines, but no one likes them. Could this year be a turning point?

    Never before has the world awaited a new medicine with such bated breath. A vaccine for Covid-19 has the potential to unlock society and save millions of people from death and serious disease, and the hero of the hour is an industry that is often regarded with disdain.

    “Traditionally and historically, public trust in pharma has been comparable to the trust they put in their broadband provider,” said Alex Davies, a healthcare PR expert at Hanover Communications, which counts many drug companies as clients.

    Continue reading…

    4th Antigen Specific Immune Tolerance Summit

    The 4th Antigen Specific Immune Tolerance Digital Summit (ASIT) brings together industry representatives from the fields of autoimmunity, allergy, immuno-oncology and transplantation to tackle the complexities behind autoimmune disorders head on. With momentum building for antigen specific immunotherapies, ASIT 2021 will be the only antigen-specific summit offering thought-leading content to drive the field towards a more precise and ethical antigen-specific approach to drug development.

    This is the industry’s definitive antigen specific drug development forum.

    Across 3 packed days, thought leaders from NovartisImCyseHarvard Medical SchoolToleranziaToralgen will reveal insight, data, and lessons learned from the last 12 months to enable you to hurdle the roadblocks preventing the development of clinically safe and effective antigen-specific immunotherapies for autoimmune and immune mediated disorders.

    Access the official agenda for more information.

    The post 4th Antigen Specific Immune Tolerance Summit appeared first on .

    J&J files lung cancer bispecific amivantamab for FDA approval

    Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC).

    J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.

    Janssen has ambitions to expand the use of the drug into the larger EGFR inhibitor market, which at the moment, is led by AstraZeneca’s fast-growing EGFR tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib).

    Amivantamab (formerly JNJ-6372) is a bispecific or double-headed antibody, combining an EGFR-binding domain at one end with one targeting mesenchymal epithelial transition (MET) factor, which is a common resistance mechanism that can reduce the activity of EGFR drugs.

    That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).

    Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use.

    EGFR mutations are some of the most common mutations in NSCLC, and that has driven sales of Tagrisso – the standard of care for previously-untreated EGFR-positive NSCLC – to more than $3 billion last year.

    The Exon 20-mutated population is fairly large in its own right, as these mutations are the third most prevalent primary EGFR mutation. That said, they often go undetected, so J&J will have to develop ways to identify suitable patients if amivantamab is to make headway in the market.

    In the summer, the drugmaker signed partnered with Guardant Health to seek regulatory approval of a companion diagnostic for amivantamab that will be used to identify suitable patients.

    Along with the marketing approval submission, J&J has also set up an expanded access programme, which would allow patients at need to use the drug while the FDA review is underway.

    Patients with exon 20 insertion mutations have a median survival of less than 17 months, around half that of patients with other EGFR mutations.

    Amivantamab has been filed for approval based on the phase 1 CHRYSALIS study which showed that the drug shrank tumours in 36% of all patients in the study, and 41% of those previously treated with chemo. The median durations of response were 10 months and seven months, respectively.

    CHRYSALIS also included an arm that combined amivantamab with lazertinib, an experimental EGFR TKI that J&J licensed from South Korea’s Yuhan in 2018, which showed a 100% ORR with the combination in previously-untreated EGFR-mutant NSCLC.

    That result prompted J&J to start a phase 3 trial comparing the duo to Tagrisso directly in treatment-naïve patients. Called MARIPOSA, it will compare Tagrisso to lazertinib alone as well as the combination.

    Meanwhile, J&J is also exploring the use of amivantamab in patients who have failed TKI therapy and only have chemo as an option.

    Both lazertinib and amivantamab – which was developed using technology from Danish biotech Genmab –  have blockbuster sales potential, according to the company.

    The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on .

    Insights+ Key Biosimilars Events of November 2020

    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

    Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

    Published: Nov 03, 2020

    Product: CT-P17 (biosimilar, adalimumab)

    • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
    • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
    • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

    Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

    Published: Nov 06, 2020

    Product: FYB201 (biosimilar, ranibizumab)

    • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
    • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
    • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

    Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

    Published: Nov 09, 2020

    Product: FYB202 (biosimilar, ustekinumab)

    • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
    • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
    • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

    Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

    Published: Nov 09, 2020

    Product: Biosimilar

    • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
    • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
    • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

    Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

    Published: Nov 13, 2020

    Product: Proposed Bevacizumab Biosimilar

    • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
    • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
    • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

    Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

    Published: Nov 11, 2020

    Product: Tuznue (biosimilar, trastuzumab)

    • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
    • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
    • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

    Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

    Published: Nov 11, 2020

    Product: SB16 proposed biosimilar to Prolia

    • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
    • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
    • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

    Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

    Published: Nov 11, 2020

    Product: HLX14 (denosumab, biosimilar)

    • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
    • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
    • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

    Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

    Published: Nov 11, 2020

    Product: Xlucane (biosimilar, ranibizumab)

    • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
    • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
    • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

    Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

    Published: Nov 16, 2020

    Product: HLX15 (biosimilar, daratumumab)

    • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
    • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
    • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

    Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

    Published: Nov 16, 2020

    Product: SB11 proposed biosimilar to Lucentis

    • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
    • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
    • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

    Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

    Published: Nov 18, 2020

    Product: SB11 proposed biosimilar to Lucentis

    • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
    • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
    • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

    The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

    Published: Nov 19, 2020

    Product: Biosimilar

    Shots:

    • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
    • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
    • The draft guidance is to be published in the Federal Register on Nov 20, 2020

    Alvotech Reported the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

    Product: Nov 20, 2020

    Product: AVT02, a proposed biosimilar to Humira

    • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
    • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
    • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

    Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

    Published: Nov 20, 2020

    Product: HLX04 (biosimilar, bevacizumab)

    • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
    • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
    • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

    Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

    Published: Nov 20, 2020

    Product: SAIT101 (biosimilar, rituximab)

    • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
    • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
    • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

    The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

    Product: Nov 20, 2020

    Product: Nyvepria (biosimilar, pegfilgrastim)

    • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
    • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
    • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

    Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

    Product: Nov 23, 2020

    Product: Byvasda (biosimilar, bevacizumab)

    • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
    • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
    • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

    Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

    Published: Nov 23, 2020

    Product: Sulinno (biosimilar, adalimumab)

    • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
    • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
    • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

    Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

    Product: Nov 25, 2020

    Product: Biosimilar

    • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
    • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
    • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

    Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

    Product: Nov 26, 2020

    Product: BAT1706 (a proposed biosimilar to Avastin)

    • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
    • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
    • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

    Related Post: Insights+ Key Biosimilars Events of October 2020

    The post Insights+ Key Biosimilars Events of November 2020 first appeared on PharmaShots.

    AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

    Shots:

    • Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
    • The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
    • Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries

    Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Wikipedia

    The post AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~0M first appeared on PharmaShots.

    AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

    Shots:

    • The P-IIb study will evaluate three dose levels of ION449 (once a month, SC) vs PBO and will enroll ~108 patients aged 18-75yrs., who have LDL-C levels b/w 70-190 mg/dL and are receiving moderate/ high-intensity statin therapy
    • The P-I study results demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90% and ~70% respectively
    • AstraZeneca granted $20M as a milestone to Ionis for the initiation of the P-II study. ION449 is antisense therapy designed to reduce blood cholesterol levels in patients with dyslipidemia by targeting PCSK9

    Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The New York Times

    The post AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol first appeared on PharmaShots.

    AstraZeneca sells rights to cholesterol drug Crestor to Grunenthal

    AstraZeneca is to sell European rights to its cholesterol drug Crestor (rosuvastatin) to Germany’s Grunenthal.

    Crestor is a statin and at its peak generated annual revenues of more than $7 billion but it lost patent protection in the US four years ago and sales have tumbled.

    Grunenthal will pay $320 million up front for rights to Crestor and associated medicines in over 30 countries in Europe, except for the UK and Spain.

    The German pharma could also make milestone payments of up to $30 million and the deal is expected to be completed in the first quarter of 2021.

    AZ will continue to manufacture and supply Crestor to Grunenthal during a transition period. AstraZeneca will also continue selling the medicine in other countries, including those in North America, Japan, China and other emerging markets.

    AZ has a strategy of selling off its older drugs and reinvesting the proceeds in its research pipeline.

    This has helped the company overcome one of the worst patent cliffs in the industry as Crestor and several other blockbusters encountered generic competition.

    Income arising from the upfront and future payments will be reported in AstraZeneca’s financial statements within other operating income and expense.

    The divestment will not impact the company’s financial guidance for 2020.

    Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, said: “This agreement supports the management of our mature medicines to enable reinvestment into the pipeline and bringing new, innovative treatments to patients.

    “Grunenthal previously acquired the rights to several established AstraZeneca medicines and is well placed to ensure continued access to Crestor for patients across Europe.”

    Crestor is a lipid-lowering medicines and is used to treat blood disorders and to prevent cardiovascular events such as heart attacks and strokes.

    It produces its lipid modifying effects in two ways: it blocks an enzyme in the liver causing the liver to make less cholesterol, and it increases the uptake and breakdown by the liver of cholesterol already in the blood.

    The post AstraZeneca sells rights to cholesterol drug Crestor to Grunenthal appeared first on .

    AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

    Shots:

    • The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D
    • The study demonstrated reduced the risk of the composite outcome by 26% along with a reduction in the risk of CV death or worsening of HF events, including hospitalization for HF
    • Additionally, Forxiga is currently being tested for HFpEF in the P-III DELIVER trial with data readout anticipated in the H2’21

    Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: ABC News

    The post AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure first appeared on PharmaShots.

    Different age groups may get different Covid vaccines, experts say

    Oxford/AstraZeneca planning new trial of lower-dose jab to see how well it works in older people

    Concerns around the efficacy of the Oxford University/AstraZeneca coronavirus jab in older people could lead to different age groups being given different vaccines, experts have said.

    The partners announced last week that the vaccine had a 70% efficacy overall. For most trial participants – given two full doses, spaced a month apart – the efficacy was 62%, but for 3,000 participants mistakenly given half a dose for their first jab, the efficacy was 90%. No participants, regardless of dosing, developed severe Covid or were hospitalised with the disease.

    Continue reading…

    AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review

    AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data.

    The shot, known as AZD-1222, developed in partnership with Oxford University, has dominated the pharma news agenda this week after it hit efficacy targets but appeared short of rivals from Pfizer and BioNTech.

    With an overall efficacy of 72%, below the 95% seen with rivals, AZ’s vaccine would have been even weaker had it not been for a stronger potency seen in patients accidentally treated with a half dose followed by a full dose.

    Now CEO Pascal Soriot wants to conduct a new test to confirm the 90% efficacy rate of the lower dose regimen, which was stumbled upon because of a manufacturing mistake.

    The companies did not disclose the error at the time and there are concerns over their transparency, Bloomberg news reported.

    Soriot told Bloomberg: “Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study.”

    This will likely be another international study but could be faster as it will require fewer patients due to the higher efficacy seen with the revised dosing regimen.

    The additional trial is unlikely to hold up regulatory approvals in the UK and EU, according to Soriot.

    Health secretary Matt Hancock has asked the UK’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA) to begin its review of the vaccine.

    The Department of Health and Social Care said the UK could be one of the first in the world to receive the vaccine if authorised.

    AZ is set to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March.

    The government also has pre-ordered 40 million doses of the Pfizer/BioNTech vaccine, which could be more than 90% effective but is harder to store and distribute as it needs to be kept extremely cold to retain its integrity.

    The post AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review appeared first on .

    Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

    AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with the highest efficacy– but the revelation has drawn a mixed response from commentators.

    The company’s share price has tumbled since the announcement of the trial results from AZD-1222 at the beginning of the week, reflecting an overall loss of confidence in the company’s handling of the trial.

    This was also reflected in numerous press reports that called into question the strength of the findings, particularly in the smaller group of patients who were given the lower dose.

    As pointed out by the New York Times, there were fewer than 2,800 volunteers who got the more effective dose, which was accidentally given at half strength followed by a full strength dose 28 days later.

    There were more than 23,000 participants in the data from the UK and Brazil, and the numbers used to calculate efficacy are lower than those used by rivals such as Moderna and Pfizer/BioNtech to calculate efficacy.

    Pfizer tested its vaccine on more than 43,000 people and Moderna based its findings on more than 30,000 patients.

    And then there’s the question of the deviation from the trial protocol that AZ’s research chief Mene Pangalos admitted to earlier this week.

    After realising several thousand volunteers had accidentally received the wrong dose, Oxford University academics running the trial decided to press on regardless with the weaker dosing regime, breaking with the predetermined design.

    As pointed out by Canada’s CBC, the change was okayed by regulators but nevertheless the stronger effect could still be a statistical quirk.

    There was another confounding factor in that none of the people in the low-dose group were more than 55 years old.

    Younger people would tend to produce a stronger immune response than older people, which could account for the differing results.

    The decision to pool results and give a composite figure from the two dose strengths is another factor that is causing concern.

    Moncef Slaoui, who leads the US COVID-19 vaccine programme Operation Warp Speed has told reports that his team are trying to determine what immune response the vaccine produced.

    A separate study being conducted in the US may be modified to include the half-dose followed by a full strength booster, said Slaoui, who used to be GlaxoSmithKline’s vaccines chief.

    Many reports point out that AZ’s shot has an advantage in that it can be stored in fridges instead of at the ultra-cool temperatures required by those from Moderna and Pfizer.

    But trial results from these mRNA-based rivals seem to be much cleaner and could pave the way to faster decisions from regulators, which could be due in the next few days.

    The post Concerns emerge after AZ’s lucky vaccine trial ‘mistake’ appeared first on .

    A vaccine revolution | podcast

    Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, production and distribution, is the end of the pandemic within reach?

    After a gruelling year of successive waves of Covid-19 infections and national lockdowns there has been a burst of good news this month, with three separate vaccine candidates performing extremely well in clinical trials.

    First, Pfizer and Moderna announced that their vaccines were testing at an efficacy of around 95%. Then came the news that the AstraZeneca vaccine (the one pre-ordered in bulk by the UK government) was hitting 90%. It marks not just a new phase in the Covid-19 pandemic but potentially a revolution in vaccine technology itself.

    Continue reading…

    Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’

    The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.

    Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.

    Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).

    That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.

    AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

    Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”

    At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.

    The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.

    Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

    “Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.

    Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

    Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.

    Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.

    So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.

    The post Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’ appeared first on .

    AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

    The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

    Vaccine results bring us a step closer to ending Covid, says Oxford scientist

    Latest breakthrough comes as PM says he hopes most at-risk could be immunised by Easter

    The world is moving a step closer to ending the coronavirus pandemic, the scientist behind Britain’s first vaccine has declared, as Boris Johnson said he hoped the majority of those most at-risk could be immunised by Easter.

    Successful trial results for the Oxford University/AstraZeneca vaccine, suggesting it could protect up to 90% of people, are the third set of promising findings in as many weeks. Before this year, there had never been a vaccine for a coronavirus.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

    Continue reading…

    Why AstraZeneca’s reward for Covid vaccine is a share price slump | Nils Pratley

    Despite the promising trial data, a viable – and profitable – vaccine is still some way off

    The stock market is cruel. AstraZeneca’s reward for unveiling promising data for its “vaccine for the world”, developed in partnership with Oxford University, was a 3.8% fall in its share price. No gratitude there – just a decline of roughly £4bn in the company’s value.

    Investors have to react somehow, but the strong response looks odd. AstraZeneca, remember, has pledged to distribute the vaccine at cost during the course of pandemic. For the purposes of that pledge, it’s a little vague who decides when the pandemic is over. But it has always been reasonably clear that AstraZeneca won’t make profits from the initial orders that have been received from governments and international bodies. So the day when the company can move to a for-profit model (with supplies to poorer nations remaining at cost) is still some way off.

    Continue reading…

    Oxford/AstraZeneca vaccine ‘likely first to be widely used in UK’

    Experts say Pfizer/BioNTech product faces more logistical challenges and obstacles

    The Oxford vaccine is likely to be the first Covid jab that large numbers of Britons receive, despite Pfizer’s candidate already being analysed by the medicines regulators, experts say.

    The fact that the Oxford vaccine can be kept in normal fridges, whereas Pfizer’s product has to be stored at -75C , may see it enter widespread usage ahead of the latter.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

    Continue reading…

    ‘It’s a great day’: Oxford coronavirus vaccine volunteers on trial data

    Trial participants react to news that Oxford AstraZeneca Covid vaccine has up to 90% efficacy

    Dan McAteer describes his reaction more as a sense of relief than elation when his phone pinged on Monday morning with a push alert reporting that the Oxford AstraZeneca vaccine has up to 90% efficacy.

    Several months on from becoming one of thousands of volunteers in trials of the Covid-19 vaccine, the 23-year-old student is trying to comprehend the news that people could be vaccinated as early as next month

    Related: Oxford AstraZeneca Covid vaccine: everything we know so far

    Continue reading…

    AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

    Shots:

    • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
    • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
    • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NBC News

    The post AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19 first appeared on PharmaShots.

    Oxford AstraZeneca results open up Covid vaccine to developing countries

    Jab can be kept in fridge and is part of global initiative to distribute doses at limited cost

    The efficacy of the Oxford University/AstraZeneca vaccine opens the way for a cheap and more easily transportable vaccine to be made available to some of the world’s poorest countries.

    Unlike the Pfizer-BioNTech vaccine, AstraZeneca’s experimental vaccine is already a part of Covax, the global initiative which hopes to distribute some 2bn doses to 92 low- and middle-income countries at a maximum cost of $3 a dose.

    Related: Latest vaccine success is good news but high price may restrict access

    Continue reading…

    AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

    AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective.

    AZ made the announcement as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

    Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

    Another regimen of the vaccine codenamed AZD1222, given to 8,895 patients showed 62% efficacy when given as two full doses at least one month apart.

    The combined analysis shows efficacy of 70% and the company said there were no serious safety events confirmed as related to the vaccine.

    AZ said the trial has therefore met its main efficacy goal and will immediately prepare filings to regulators around the world to allow early approval.

    It will also seek an Emergency Use Listing from the World Health Organization to make the shot quickly available in low income countries.

    AZ made no further reference to the safety scare that caused trials of the vaccine to be halted for several weeks in September.

    The AZ vaccine also has a considerable convenience advantage over RNA-based vaccines from Pfizer and Moderna.

    The AZ shot can be stored at refrigerator temperatures making distribution much easier, while the vaccines from Pfizer and Moderna require ultra-cool temperatures to prevent their active ingredients from breaking down.

    AZD-1222 is based on a weakened cold virus that causes the disease in chimpanzees, which has been modified so that it causes the body to code for the “spike” protein seen on the surface of the SARS-CoV-2 coronavirus that causes COVID-19.

    The body produces antibodies against the protein, which neutralise the coronavirus in the event of an infection.

    AZ announced the news as reports suggested the UK could approve Pfizer’s rival by the end of the week.

    Citing a gated report from the Daily Telegraph, Reuters said the Medicines and Healthcare Products Regulatory Agency could have concluded its review of the shot developed by Pfizer and BioNTech by the end of the week.

    This would allow distribution of the vaccine to begin during the first week in December.

    Feature image courtesy of Rocky Mountain Laboratories/NIH

    The post AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival appeared first on .

    Regeneron’s COVID-19 antibody cocktail gets US emergency licence

    Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available.

    The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues.

    Formerly known as REGN-COV2 or REGEN-COV2, the cocktail can be used for mild to moderate COVID-19 in adults and children at least 12 years of age and weighing at least 40 kg.

    Doctors now have another option to choose from to combat the disease, following EUAs for drugs such as Eli Lilly’s baricitinib and Gilead’s Veklury (remdesivir).

    To be eligible for Regeneron’s combination, patients must have received positive results of direct SARS-CoV-2 viral testing and be considered at high risk for progressing to severe COVID-19 and/or hospitalisation.

    Clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

    As part of the Operation Warp Speed project to rapidly develop therapies and vaccines against the disease, the US government and Regeneron a supply agreement for the cocktail, which was famously used to treat president Donald Trump after he became infected.

    Regeneron will coordinate with state authorities to allocate the cocktail on a weekly basis, based on prevalence of the disease in each state.

    The first 300 doses will be provided at no cost to patients, although hospitals and clinics may add their own fees.

    AmerisourceBergen will be the first national distributor to begin delivering the therapy.

    Earlier this month, Regeneron had to modify a trial protocol for the therapy after independent safety experts said it should not be given to high-risk patients after an undisclosed safety issue emerged in testing.

    In late October, Eli Lilly said it wouldn’t resume a trial of its rival antibody therapy in hospitalised patients after National Institutes of Health researchers said it wouldn’t help.

    AstraZeneca is developing a long-acting antibody therapy combination in the US and other countries to prevent infection happening and as a therapy for those already infected.

    Regeneron’s antibodies were designed to combat SARS-CoV-02 using the company’s proprietary genetically modified mice, which have been engineered to have a human immune system.

    The antibodies bind non-competitively to the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

    The post Regeneron’s COVID-19 antibody cocktail gets US emergency licence appeared first on .

    The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

    Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed

    In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could stop their spread.

    Their insights have in turn been taken up by health professionals. Hearsay can be useful, helping to catch disease outbreaks. It can also be deadly. Though vaccine hesitancy is as old as vaccines themselves, it has risen sharply in many countries in recent years. Unfounded scare stories about the safety of immunisation programmes have contributed to growing scepticism and outright refusal, with fatal consequences. In her new book Stuck: How Vaccine Rumours Start – and Why They Don’t Go Away, Prof Heidi Larson notes the paradox: we have better vaccine science, more safety regulations and processes than ever before, yet a doubting public.

    Continue reading…

    Trials to begin in UK for Covid antibody cocktail drug treatment

    Scientists say jab could be used to protect those who cannot be given vaccines

    Major trials will begin this weekend of an antibody cocktail that scientists hope will protect people against Covid-19 and could be swiftly used in care homes or on cruise ships in the event of an outbreak.

    A UK volunteer will be given the first dose of a drug that is expected to give vulnerable people immediate protection. The jab into the muscle of the arm takes effect straight away and could last for six months to a year. If it works as well as scientists predict, it could be used to protect those who cannot be given vaccines because of their state of health.

    Continue reading…

    Encouraging data from AZ/Oxford coronavirus shot

    The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found.

    The phase 2/3 trial results published in The Lancet about the UK-developed shot follow more detailed findings from Pfizer/BioNTech showing that their vaccine protected 94% of adults over 65 years old.

    Although both vaccines are not yet approved by regulators, the results are encouraging as older people seem to be most at risk from the virus.

    The results from the UK-developed vaccine, codenamed AZD1222, come from a trial in 560 healthy adult volunteers.

    Results from the phase 2 component of the trial were published ahead of phase 3 data expected in the coming days or weeks, which will provide a much clearer picture about the vaccine’s safety and efficacy.

    Those taking part were assessed to see if they were fit and healthy enough to take part before being assigned to receive either an intramuscular injection of the coronavirus vaccine or a control vaccine.

    Booster regimes were given 28 days apart and dosing regimen varied according to age group.

    Findings showed that the vaccine, which is based around a weakened chimpanzee cold virus, produced a similar immune response across all age groups and was better tolerated in older adults than in younger adults.

    Regulators in the UK and Europe have begun rolling reviews of several coronavirus vaccines, including the Oxford vaccine, but these results will not be enough for them to fully assess its safety and efficacy.

    The data needed for that will come from the larger phase 3 trial, which will be reviewed quickly by the regulators in real-time under the rolling review to hasten a decision.

    Separate results published by Pfizer yesterday show the vaccine it is developing with Germany’s BioNTech protect around 94% of adults over 65 years old.

    The trial involved 41,000 people worldwide, half of whom received the vaccine, with the remainder given a placebo.

    These latest figures from the older age group are an improvement on the 90% overall efficacy figures announced in top-line results earlier this month.

    Pfizer is reportedly close to filing results with the FDA for an Emergency Use Authorization after gathering the required amount of safety data.

     

    The post Encouraging data from AZ/Oxford coronavirus shot appeared first on .

    Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley

    While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out

    A second coronavirus vaccine candidate was always likely to struggle to match the excitement of the first, at least in stock market terms. Sure enough, Moderna’s promising trial results merely added to the generally bullish mood in markets without generating the same sense of wild relief, and 5% rise in the FTSE 100 index, that Pfizer and BioNTech achieved a week ago.

    But, actually, the key difference with Moderna’s version looks significant. It’s the fact the company says its vaccine can be transported and stored for up to six months at -20C and will then remain stable for 30 days at fridge temperatures. By contrast, Pfizer and BioNTech spoke about -75C in storage and then only five days of stability in conventional fridges.

    Continue reading…

    Moderna vaccine’s effectiveness bodes well for Oxford/AstraZeneca jab

    Phase 3 success rate of 95% for US firm’s treatment is promising for UK vaccine trial

    Hopes are rising for the Covid jab being developed by Oxford University, after Moderna became the second company to reveal impressive results from its vaccine trials.

    Interim results from phase 3 clinical trials of the Covid vaccine from US company Moderna has revealed it to be almost 95% effective at preventing the disease. The news followed an announcement last week from Germany-based Pfizer and BioNTech that their vaccine was more than 90% effective.

    Continue reading…

    Where will poorer countries stand in the queue for a Covid-19 vaccine? | Clare Wenham and Mark Eccleston-Turner

    The lion’s share of the potential Pfizer vaccine is already claimed by high-income nations

    The news that joint efforts by the US pharmaceutical company Pfizer and the German biotech company BioNtech have produced a vaccine that is 90% effective at protecting people from Covid-19 has been understandably applauded – in spite of the caveats. Pfizer states that it can manufacture up to 50m doses by the end of 2020 and up to 1.3bn doses in 2021.

    Given the desire to get life back to normal, these doses will be in incredibly high demand. Some governments around the world, including the UK, have already begun to indicate to their populations that they will receive a vaccine by Christmas. But how will the distribution of this finite number of vaccines work when we only have enough for one seventh of the global population?

    Related: Pfizer and BioNTech’s vaccine poses global logistics challenge

    Clare Wenham is assistant professor of global health policy at the LSE. Mark Eccleston-Turner is a lecturer in Global Health Law at Keele University

    Continue reading…

    AZ drug hunter Garry Pairaudeau joins AI specialist Exscientia

    Drug discovery firm Exscientia has beefed up its leadership team with the appointment of former AstraZeneca scientist Dr Garry Pairaudeau as its chief technology officer.

    Pairaudeau – who will report directly to Exscientia chief executive Prof Andrew Hopkins – has been at AZ for 25 years, most recently as head of hit discovery with a brief covering high-throughput screening and virtual screening, computational chemistry, machine learning, and DNA-encoded libraries.

    He also served as chair of AZ’s Global Chemistry Leaders Network, with responsibility for implementing strategic initiatives and collaborations, and championed developments in artificial intelligence (AI), machine learning,  physics-based computation and automation.

    Pairaudeau joins Exscientia at a fertile time for the UK biotech, which specialises in applying artificial intelligence to the drug discovery process and reckons its approach can carve up to 75% off the time it takes to find preclinical candidates.

    The company hit the headlines earlier this year when it started clinical trials of the first drug molecule invented entirely using AI – a potential treatment for obsessive-compulsive disorder (OCD) partnered with Sumitomo Dainippon Pharma.

    It then built on that success with a $60 million third-round financing in May – led by Novo Holdings – which is being used to build out its drug pipeline.

    At Exscientia, Pairaudeau will be responsible for making sure Exscientia becomes “the most efficient drug discovery organisation in the world.”

    Among his past achievements was the Malcolm Campbell award from the Royal Society of Chemistry (RSC), which he shared with other scientists for the discovery of Brilinta (ticagrelor), AZ’s blockbuster antiplatelet medication which is used with aspirin to lower a patient’s chance of having another heart attack, stroke or blood clot.

    “Garry has forged a long-standing impressive career that has combined real-life drug hunting with cutting edge computational and AI techniques as well as robotics”, said Hopkins.

    He added that the new CTO “has the rarest of talents of both a deep understanding of the problems of drug discovery and a drive to lead the development of new AI and automation approaches to solve those problems.”

    Interest in using AI and machine learning to boost efficiency of drug discovery and development has been rising as the biopharma industry is facing declining returns on investment, and desperately needs more efficient R&D methods to boost productivity.

    The global market for AI in healthcare was worth $2.1 billion in 2018, with exponential growth to $36 billion predicted by 2025, at a combined annual growth rate of 50.2%, according to a recent report by finnCap.

    The post AZ drug hunter Garry Pairaudeau joins AI specialist Exscientia appeared first on .

    AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

    Shots:

    • The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS
    • Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall population. The study also met 1EPs in patients with low levels of eosinophils i.e. <300 & 150 cells/microlitre
    • Tezepelumab is mAb that inhibits the action of TSLP and has received US FDA’s BT designation in Sept’2018 for patients with severe asthma, without an eosinophilic phenotype

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

    The post AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma first appeared on PharmaShots.

    With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

    Finish line ahead

    The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

    AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

    Shots:

    • The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days
    • Results demonstrated a reduction in the rate of the composite 1EP of stroke & death by 17%, risk of severe bleeding events (0.5% vs 0.1%). Regulatory submissions to expand the approved indication are under regulatory review in China and the EU
    • Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. The approval follows the US FDA’s PR designation granted in Jul’2020

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pinterest

    The post AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack first appeared on PharmaShots.

    AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

    Shots:

    • The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
    • Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
    • Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020

    Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

    The post AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer first appeared on PharmaShots.

    AZ’s Q3 results disappoint – but COVID19 vaccine trial is still on track

    AstraZeneca has posted an uninspiring set of quarterly results as it gears up for results from its closely watched coronavirus vaccine trial.

    AZ said in its third quarter results statement that it is on track to meet its guidance for the year, with total revenue expected to grow by 8%-12% and core earnings per share increasing by 15%-19%.

    In the three months to the end of September AZ’s revenue increased by 3% to $6.6 billion, with products sales up 6%.

    Earnings per share fell to $0.94, missing analysts’ estimates of $1, as some patients held off treatments for ailments unrelated to COVID-19.

    AZ has pursued a strategy of selling off its older or unwanted drugs and has been benefiting from “collaboration revenue” from these deals as development partners reach certain milestones.

    This revenue fell by 79% to $58 million compared with the same quarter last year, although the company said that this was down to a strong performance in last year’s Q3.

    The company suggested that collaboration revenue may be higher in the next quarter as this income tends to come in chunks as various research projects reach fruition or sales targets are met.

    At the same time the company also grabbed two new European approvals – for Lynparza in castration-resistant prostate cancer and for Forxiga for a form chronic heart failure.

    The company’s coronavirus vaccine is perhaps the company’s most eagerly-watched pipeline asset, although AZ is unlikely to make much money from it – at least until the worst of the pandemic is over.

    As reported by pharmaphorum earlier this week, AZ expects results from its late-stage trial by the end of the year despite a safety scare in September, setting up approval by regulators early in 2021.

    AZ has pledged to sell the vaccine at cost price until a cut-off point expected midway through next year.

    But as the UK heads for another economically damaging month-long lockdown the company confirmed that it could have crucial phase 3 data from the vaccine by the end of the year.

    If approved the vaccine will do little for the company’s figures but will create huge goodwill as governments across the world seek an end to the spiral of death caused by the coronavirus.

    The post AZ’s Q3 results disappoint – but COVID19 vaccine trial is still on track appeared first on .

    Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs

    An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC).

    The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck drugs.

    The first trial, called Acclaim-1, will pair EGFR inhibitor Tagrisso (osimertinib) with Reqorsa as a second-line treatment for EGFR-mutated NSCLC patients whose cancer has progressed after first-line Tagrisso treatment.

    The Acclaim-2 trial meanwhile will add Reqorsa to PD-1 inhibitor Keytruda (pembrolizumab) in NSCLC patients with PD-L1 expression levels of 1% to 49%, according to the partners. Both studies are due to start in the first half of next year.

    Tagrisso is the top-selling EGFR inhibitor, with sales of almost $3.2 billion last year, while Keytruda dominates the market for cancer immunotherapies for NSCLC, accounting for a large chunk of its $11 billion-plus 2019 sales tally.

    If positive, the trials would allow Reqorsa to piggyback on that success – assuming it makes it to market. So far, Genprex only has data for the therapy from two phase 1 trials, and part of a phase 2 study showing preliminary evidence of safety as well as efficacy in NSCLC.

    Genprex’ therapy takes the form of a copy of the TUSC2 gene in a non-viral lipid nanoparticle formulation, delivered via an intravenous infusion, and was originally developed at the University of Texas’ MD Anderson Cancer Centre in the US.

    After infusion, the nanoparticles are taken up by tumour cells, says Genprex, and leads to the expression of the TUSC2 gene into a protein that reprograms them to die.

    In preclinical studies, the gene therapy also seems to block mechanisms involved in drug resistance, including TIM3, a bypass pathway that can lead to failure of PD-1-based therapy.

    The FDA awarded fast-track status to the Tagrisso/Reqorsa for the treatment of EHGFR-mutated NSCLC earlier this year, as nearly all patients receiving AZ’s drug eventually experience disease progression.

    According the company’s data, the median time to progression after first-line Tagrisso is about 18 months.

    Austin-based Genprex has been preparing for the Reqorsa clinical trials programme, over the last few months, ramping up its manufacturing capacity for the gene therapy via an agreement with contract manufacturing organisation (CMO) Aldevron.

    The post Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs appeared first on .

    AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

    Shots:

    • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
    • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
    • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

    Click here to­ read the full press release/ article | Ref: Fusion Pharmaceuticals | Image: Moffitt

    The post AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer first appeared on PharmaShots.

    UK could get COVID-19 vaccines early next year, ahead of European countries

    COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling reviews of shots from AstraZeneca and Moderna.

    AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the COVID-19 vaccine it developed in conjunction with Oxford University.

    This followed last week’s news that the MHRA has begun a parallel rolling review of a rival from Moderna.

    The rolling review allows for a real-time assessment of the clinical data from clinical trials, accelerating a process that normally takes around a year to complete using the centralised European regulatory system.

    Using the MHRA could allow the UK to make regulatory decisions on COVID-19 vaccines ahead of the European system, where medicines and vaccines are first reviewed by the CHMP scientific committee before being passed on to the European Commission.

    But a source close to process told pharmaphorum that it is “eminently possible” that the MHRA could reach its conclusions ahead of its European counterparts as the country reaches the end of the Brexit transition period.

    A spokesperson for the MHRA said that from 1st January, it will have new powers to approve medicines, including vaccines including “greater flexibility to do this faster, while maintaining the highest standards of safety, quality and effectiveness.”

    The spokesperson said: “The MHRA will evaluate the data rigorously on the quality, safety and effectiveness of COVID-19 vaccines to reach a scientifically robust independent opinion if an earlier authorisation is necessary before the EMA (European Medicines Agency) authorises a product.”

    “Patient safety is our top priority. The independent Commission on Human Medicines will advise the UK government on the safety, quality and effectiveness of any potential vaccine. No vaccine will be deployed in the UK unless stringent standards have been met through a comprehensive clinical trial programme”

    Representatives of the MHRA used to sit on the CHMP but no longer participate as a result of Brexit, leaving the UK to make its own decisions on medicines regulation should it choose to do so.

    According to the source, COVID-19 vaccines could be available in early January depending on the length of time it takes for trial data to be published and shared with regulators.

    COVID vaccines are being developed at warp speed, with the development and review process that normally takes up to a decade to complete compressed into less than a year after research began at the end of January.

    The MHRA’s approach to the AZ and Moderna vaccines also paves the way for similar fast reviews to rivals from the likes of Pfizer/BioNTech and Novavax, which the UK government also has on order and are reaching the end of the clinical trial process.

    The news comes as the country prepares for another national lockdown, which will disrupt business and limit people’s freedoms for at least another month.

    A vaccine is seen as a potential way out of the cycle of lockdowns that have already caused severe hardship across the UK, which is one of the countries worst hit by COVID-19.

    An AstraZeneca spokesperson told pharmaphorum: “Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted. It is then up to the regulatory bodies to review and make approval decisions based on this data, as quickly as possible.

    “The EMA announced in October that its CHMP had started a ‘rolling review’ of data for AZD1222, the first COVID-19 vaccine to be evaluated under these arrangements. We confirm the MHRA’s rolling review of our potential COVID-19 vaccine.”

     

    The post UK could get COVID-19 vaccines early next year, ahead of European countries appeared first on .

    PharmaShots’ Key Highlights of Third Quarter 2020

    The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.

    Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK

    Date – Sept 25, 2020

    Product – NVX-CoV2373

    • Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
    • Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
    • The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually

    J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine

    Date- Sept 24, 2020

    Product- JNJ-78436735

    • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
    • The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
    • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective

    Illumina Acquired GRAIL for ~$8B

    Date – Sept 22, 2020

    Deal Value – ~$8B

    • Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
    • GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
    • The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications

    Fitbit to Launch ECG App in the US and EU in October 2020

    Date – Sept 15, 2020

    Product – ECG App

    • Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
    • The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
    • Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel

    Novartis’ Beovu (brolucizumab) Received EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

    Date – Sept 15, 2020

    Product – Beovu (brolucizumab)

    • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
    • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
    • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of AEs

    Gilead Acquired Immunomedics for ~$21B

    Date – Sept 14, 2020

    Deal Value – ~$21B

    • Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
    • The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
    • Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21

    Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics

    Date – Sept 14, 2020

    Deal Value – ~$4.5B

    • Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
    • The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
    • Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory

    Novartis’ Kisqali (ribociclib) Received Highest Score on the ESMO Magnitude of Clinical Benefit Scale

    Date – Sept 11, 2020

    Product – Kisqali (ribociclib)

    • Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
    • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant  for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
    • New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively

    AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B

    Date – Sept 09, 2020

    Deal Value – ~$2B

    • I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
    • AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
    • The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity

    Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

    Date – Sept 07, 2020

    Product – Gavreto (pralsetinib)

    • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
    • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
    • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021

    AstraZeneca Expanded the Development of AZD1222 into P-III Study in the US Across All Adult Age Groups

    Date- Sept 01, 2020

    Product- AZD1222

    • AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
    • The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
    • The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia

    GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19

    Date- Sept 01, 2020

    Product- VIR-7831

    • The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
    • The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
    • Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21

    World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan

    Date – Aug 31, 2020

    Product – CureApp

    • On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
    • CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
    • The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app

    GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma

    Date – Aug 27, 2020

    Product – Blenrep (belantamab mafodotin-blmf)

    • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
    • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
    • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

    Novartis’ Kesimpta (ofatumumab) Received the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

    Date – Aug 21, 2020

    Product – Kesimpta (ofatumumab)

    • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
    • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
    • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

    Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B

    Date – Aug 19, 2020

    Deal Value – ~$6.5B

    • J&J acquires Momenta in all cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
    • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
    • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

    Sanofi Acquired Principia Biopharma for ~$3.68B

    Date – Aug 17, 2020

    Deal Value – ~$3.6B

    • Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
    • The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
    • The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases

    Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India

    Date – Aug 13, 2020

    Product – Remdesivir

    • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
    • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
    • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients

    Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

    Date – Aug 07, 2020

    Deal Value – ~$2.125B

    • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
    • The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
    • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs

    Siemens Healthineers Acquired Varian for $16.4B

    Date – Aug 04, 2020

    Deal Value – ~$16.4B

    • Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
    • The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
    • Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide

    Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

    Date – Aug 03, 2020

    Value – $2.1B

    • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
    • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
    • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

    Roche’s Actemra/RoActemra (tocilizumab) Failed to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

    Date – Jul 29, 2020

    Product – Actemra/RoActemra (tocilizumab)

    • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
    • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
    • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

    Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease

    Date- Jul 29, 2020

    Deal Value- ~$2B+

    • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
    • UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
    • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

    AstraZeneca Signed an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

    Date – Jul 27, 2020

    Deal Value – ~$6B

    • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
    • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
    • Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

    Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

    Date – Jul 10, 2020

    Deal Value – ~$2.1B

    • Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
    • Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
    • Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs

    Bausch Health Spun off its Eye Health Business

    Date – July 08, 2020

    Product – N/A

    • Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
    • The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
    • Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019

    Roche Signed a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

    Date – Jul 07, 2020

    Deal Value – ~$1B

    • Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
    • Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
    • Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020

    Merck KGaA and Pfizer’s Bavencio (avelumab) Received the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

    Date – Jul 01, 2020

    Product – Bavencio (avelumab)

    • The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
    • Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
    • Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

    The post PharmaShots’ Key Highlights of Third Quarter 2020 first appeared on PharmaShots.

    AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

    Shots:

    • The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries
    • The study demonstrated that Forxiga achieved a significant reduction in the composite EP of hHF or CV death. The trial confirmed the well-established safety profile of Forxiga
    • The NMPA’s label update follows the update to the EU MAA in Aug’2019 and the US FDA’s approval granted in Oct’2019

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

    The post AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study first appeared on PharmaShots.

    Oxford Covid vaccine works in all ages, trials suggest

    Vaccine being trialled by Oxford University and AstraZeneca offers hope for all age groups

    One of the world’s leading Covid-19 experimental vaccines produces an immune response in both older and young adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.

    The vaccine, developed by the University of Oxford, also triggers lower adverse responses among elderly people, said the British drug maker AstraZeneca, which is helping to manufacture the vaccine, on Monday.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Related: At 75, I’ve volunteered for a Covid vaccine trial. It could set people free

    Continue reading…

    Bayer data for kidney disease hope finerenone sets up filings

    Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial.

    Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the data under wraps other than to say the drug met the dual objectives of reducing renal and cardiovascular events in patients with type 2 diabetes and chronic kidney disease.

    Now, the 5,734-patient study has been presented at the Kidney Week 2020 congress and simultaneously published in the New England Journal of Medicine, and the data look solid.

    A second ongoing phase 3 trial – called FIGARO-DKD – is concentrating primarily on cardiovascular endpoints but also includes aptietnsd with earlier-stage kidney disease and has a read out due next year.

    Bayer is eyeing regulatory filings before the end of 2020 on the back of the FIDELIO-DKD results, which would set up a clash with SGLT2 inhibitors, drugs for diabetes that are also emerging as promising therapies for DKD.

    That includes Johnson & Johnson’s Invokana (canagliflozin) – already approved for diabetic kidney disease – as well as AstraZeneca’s Farxiga (dapagliflozin) which showed positive results in the DAPA-CKD trial in both diabetic and non-diabetic subjects just last week.

    Finerenone – billed as a first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist – reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy in FIDELIO-DKD.

    The drug also cut cardiovascular outcomes – including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke or hospitalisation for heart failure – by 14%.

    “Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, which represents an unmet medical need,” said lead investigator Prof George Bakris of University of Chicago Medicine.

    “The results with finerenone are highly relevant for these patients who currently have limited options,” he added.

    There is also a huge number of them. Diabetes is the leading cause of kidney failure, and there are estimated to be almost 850 million people worldwide with chronic kidney disease (CKD).

    If approved, finerenone would enter a market in which J&J is struggling to overturn the lingering impact of black-box warnings over amputation risks with Invokana that were dropped in the summer. The drugmaker sees kidney disease as its route to growth after a couple of years of declining sales, and is promoting the new use strongly.

    AZ meanwhile is on a roll with Farxiga, with the new data in CKD building on recent data for the drug in heart failure that is helping to drive sales growth, although patent expirations and the threat of generic competition are looming.

    Bayer is also eyeing a heart failure indication for finerenone, and now has a phase 3 trial in heart failure with preserved ejection fractions (HFpEF) in play that if successful would unlock a hitherto untapped market with no approved drugs.

    The post Bayer data for kidney disease hope finerenone sets up filings appeared first on .

    AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020

    Shots:

    • The P-lll DAPA-CKD study involves the assessing of Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ out T2D
    • Results of subgroup analysis : RRR & ARR (5.8% & 37%) for patients whose CKD was primarily driven by diabetic kidney disease; (25% & 2.2%) for high B.P.; (57% & 7.5%) for glomerulonephritis; (42% & 5.0%) for CKD of other or unknown causes (ARR = 5.0%) respectively. Also showed reduction in in all-cause mortality as secondary outcome
    • Farxiga (PO, qd) is a first-in-class SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy & combination regimen as an adjunct to diet and exercise to improve glycemic control and has received FDA’s BTD & CHMP’s recommendation in Oct’2020

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NPR

    The post AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020 first appeared on PharmaShots.

    AZ, J&J COVID-19 vaccine trials okay to restart in US

    US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.

    Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of  its coronavirus candidate JNJ-78436735, which has also suspended after one study subject fell ill.

    AZ confirmed the FDA’s move in a statement, saying that regulators in the US, UK, Brazil, South Africa and Japan have now said that trials of the Oxford University-partnered shot are safe to continue.

    The FDA took a lot longer to reach its conclusion however, as recruitment into studies restarted just a few days after the halt elsewhere.

    AZ chief executive Pascal Soriot said: “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

    On 6 September, AZ said it had put trials of AZD1222 on temporary hold because of a potential safety issue involving one patient in the UK, who had become ill after taking the vaccine with what at the time was reported to be transverse myelitis – an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.

    “It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” said AZ, which hasn’t confirmed the nature of the adverse reaction.

    A report in the Wall Street Journal suggests that the FDA has reviewed two cases of potential neurological side effects in patients receiving AZD1222. One was subsequently found to be in a patient with MS, but the US regulator couldn’t either identify or rule out a clear link to the vaccine in both cases.

    A death has also occurred in a patient enrolled onto an AZD1222 study in Brazil, although that has not been linked to the vaccine and is believed to have occurred in a subject who did not receive the shot.

    AZ is now expecting to have results from the trials before the end of the year – analysts at Jefferies think it could occur in mid-November – and rolling regulatory  reviews of AZD1222 are already underway in some markets including the EU.

    J&J meanwhile said that the independent data safety monitoring committee overseeing the phase 3 ENSEMBLE trial of JNJ-78436735 had found no clear cause behind a “serious medical event” – reported to be a stoke – in one subject that caused the study to be placed on hold earlier this month.

    “After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” said the drugmaker in a statement indicating the findings had been shared with the FDA. “There are many possible factors that could have caused the event.”

    The suspension of studies for AZD1222 and JNJ-78436735 has put two coronavirus vaccines from BioNTech/Pfizer and Moderna in the lead in the US, with top-line efficacy results due within the next 4-5 weeks, although safety data will take a little longer to come in.

    The resumption of the two stalled studies means that AZ and J&J will now not be too far behind.

    The post AZ, J&J COVID-19 vaccine trials okay to restart in US appeared first on .

    AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

    Shots:

    • The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial
    • A voluntary pause across all global studies was triggered on Sept 06, 2020, to allow the examination of safety data by independent monitoring committees. AstraZeneca has resumed the clinical trials across the globe with regulators in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so
    • While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators, and participants according to clinical trial and regulatory standards

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

    The post AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US first appeared on PharmaShots.

    AZ’s COVID-19 vaccine trial ready to resume – reports

    AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of a serious illness, according to reports.

    Citing four sources, Reuters said that the FDA is about to allow the large-scale trial of the shot to resume after it was put on hold on 6 September when a participant in the UK fell ill.

    AZ has not confirmed the nature of the illness because of concerns over patient privacy, but according to press reports the person developed the rare spinal inflammatory disorder transverse myelitis.

    Reuters said its sources were briefed on the matter but asked to remain anonymous but said the trial could resume later this week.

    It is unclear how the FDA characterised the disease that caused the stoppage and the regulator has so far declined to publicly comment on the matter.

    The FDA is requiring trial researchers to add information about the incident to consent forms signed by study participants, one of the sources told Reuters.

    UK regulators allowed the trial to resume a week after it was put on hold – according to Reuters’ sources this was because there was “insufficient evidence to say for certain” that it was not related to the vaccine.

    The Medicines and Healthcare products Regulatory Agency (MHRA) recommended that vaccinations should continue but with close monitoring of the affected person and other participants.

    The FDA has publicly stated the importance of safety data for COVID-19 vaccines – they will be given to healthy individuals and there is very little tolerance for any side effects.

    The regulator has said manufacturers must have at least two months’ worth of safety data before filing a COVID-19 vaccine, amid concerns that the Trump administration may attempt to rush approval ahead of the US election on 3rd November.

    As Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, pointed out to Reuters, regulators have to weigh whether a rare side effect is vaccine-related and could occur again.

    Transverse myelitis occurs at a rate of one in 200,000 people and he noted it would be unusual to see it in a trial of 9,000 people.

    But other viruses including West Nile and polio can trigger the condition, as well as physical trauma.

    Regulators in Brazil, India and South Africa have also allowed trials to resume.

    Until the safety issue AstraZeneca had been a frontrunner in the race to produce a vaccine for COVID-19.

    Johnson & Johnson has voluntarily put a trial of its potential rival vaccine on hold because of a safety issue.

    According to the World Health Organization, there are 44 candidate vaccines in clinical trials, with three shots developed in China listed as most advanced followed by the AZ vaccine.

    pharmaphorum has approached AZ for comment.

    The post AZ’s COVID-19 vaccine trial ready to resume – reports appeared first on .

    AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

    Shots:

    • AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
    • The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
    • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Print

    The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.

    FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer

    The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer.

    Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on the results.

    The FDA reserves these faster reviews, taking six months at the most instead of the standard ten-month timeframe, for medicines that demonstrate superior efficacy or safety for serious diseases.

    ADAURA tested Tagrisso (osimertinib) in patients with early-stage (1B, II and III) epidermal growth factor receptor-mutated (EGFR) non-small cell lung cancer (NSCLC) after complete tumour removal.

    Up to 30% of all patients diagnosed early with NSCLC in this patient group may be diagnosed early enough to have curative surgery, but disease recurrence is common and more than three quarters of patients diagnosed in Stage IIIA experience recurrence within five years.

    ADAURA was halted early this year after Tagrisso showed “overwhelming efficacy” in this patient group.

    In the trial Tagrisso reduced the risk of disease recurrence or death by 83% compared to placebo in patients with tumours that had spread locally but not to other parts of the body (stage II-IIIa), and who had surgery with the aim of completely removing the tumour and curing their cancer.

    The drug also reduced disease-free survival by 79% in the overall trial population (stage 1b to IIIa), and after two years 89% of patients remained alive, compared to 53% of the placebo group.

    It’s the first time that a targeted drug has shown an improvement in this group of patients in a large scale trial.

    Approval will be another string in the bow for Tagrisso, which is already a blockbuster bringing in revenues of more than $1 billion per quarter for the UK pharma.

    Tagrisso is a third-generation irreversible EGFR-tyrosine kinase inhibitor that was originally intended to treat patients with EGFR-mutated NSCLC after an older drug from that class has been rendered useless by a T790M mutation, which usually occurs after around 18 months of treatment.

    But since this first FDA approval in 2015 it has also been licensed in first-line treatment in EGFR-mutated lung cancer, after outperforming AZ’s older EGFR drug Iressa (gefitinib) and Roche’s rival Tarceva (erlotinib) in the phase 3 FLAURA trial.

     

    The post FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer appeared first on .

    UK government signs contract for COVID-19 challenge trial

    The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective.

    Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has signed the contract with the UK government to develop the trial model.

    This will involve manufacture of the challenge virus and the first-in-human characterisation study for the virus.

    The characterisation study, which is expected to be completed in May 2021, still needs ethical and regulatory approval.

    It is designed to assess the minimum dose of the virus required, before moving on to the next stage when a vaccine will be administered.

    The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London, under the scrutiny of highly trained scientists and medics.

    hVIVO will also be expanding its clinical operations in London to conduct the trial.

    It’s not clear which vaccine will be involved in the study – there are several in the last stages of clinical development and the UK government has orders for candidates from AstraZeneca, Pfizer/BioNTech, Novavax, Valneva, Sanofi/GSK and Johnson & Johnson.

    No financial details of the contract with hVIVO were disclosed.

    Challenge trials are controversial because of the risks involved with infecting patients with a potentially lethal virus, although with the SARS-CoV-2 coronavirus these could be managed as most people develop mild symptoms and those at high risk of a serious infection are relatively easy to identify.

    hVIVO is already known for its challenge studies in other infectious diseases, which are conducted a 24-bedroom quarantine clinic with onsite virology, providing individually isolated rooms and connected to a specialist laboratory facility.

    Open Orphan, which comprises of two commercial CRO services business hVIVO and Venn Life Sciences, has been working on several coronavirus challenge study models and expects to be busy over the next few months helping several pharma and biotech companies test their vaccines.

    Anyone interested in being contacted and provided with details about future COVID-19 human challenge study research may leave their contact details at www.UKCovidChallenge.com.

    The World Health Organization has been keeping tabs on the development of vaccines since the start of the pandemic and says there are now 44 in clinical development.

    The three most advanced are being developed in China where the pandemic is thought to have originated, followed by a candidate from Oxford University and AstraZeneca in the UK.

    Feature image courtesy of Rocky Mountain Laboratories/NIH

    The post UK government signs contract for COVID-19 challenge trial appeared first on .

    AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

    Shots:

    • The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials
    • P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi Aerosphere over 52wks. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators
    • Trixeo Aerosphere is a single-inhaler, fixed-dose triple combination of formoterol fumarate, glycopyrronium bromide with budesonide, delivered in a pressurized metered-dose inhaler, and is approved under the brand name Breztri Aerosphere in Japan, China & the US for COPD

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: TeleTrader.com

    The post AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD first appeared on PharmaShots.

    Are we near to having a vaccine for Covid-19?

    Even a once bullish PM is now not so optimistic but there are promising signs of a vaccine on the horizon

    In March, Boris Johnson said we would turn the tide in 12 weeks and “send the coronavirus packing” and by May ministers were boasting of having a vaccine by September. Last week the prime minister sounded far less confident, telling MPs that there was still no vaccine for SARS, 18 years after it emerged. A vaccine may not be far away though.

    Continue reading…

    Pfizer to wait until after election to file COVID-19 vaccine in US

    Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available.

    The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA.

    In a letter published on its website Pfizer may have the data to say whether the vaccine is effective this month, based on the findings of the ongoing 40,000 person clinical trial.

    But CEO Alfred Bourla cautioned that the safety data will only be ready in the third week of November.

    There have already been two safety scares in COVID-19 vaccine trials – Johnson & Johnson earlier this week put its phase 3 trial on hold because of an undisclosed illness in a patient.

    A US trial of AstraZeneca’s shot is also on hold after a similar incident, although studies in other parts of the world have restarted.

    As vaccines will be given to healthy individuals, regulators have far less tolerance for adverse events.

    There are further concerns that political interference during the election build-up could undermine the credibility of a mass vaccination programme.

    Bourla said: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US. soon after the safety milestone is achieved in the third week of November.”

    Despite the concerns of scientists president Donald Trump has said that there would be a vaccine available before the election on 3rd November and is hoping that approval could be the “October Surprise” that could boost his popularity ahead of the vote.

    Rival Moderna has said it could apply for an Emergency Use Authorization for its rival vaccine as soon as November.

    The European Medicines Agency has already started a rolling review of the Pfizer/BioNTech and AstraZeneca vaccines.

    The post Pfizer to wait until after election to file COVID-19 vaccine in US appeared first on .

    PharmaShots Weekly Snapshot (Oct 12-16, 2020)

    Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

    Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

    Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

    Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

    Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

    Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

    Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

    Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

    Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

    Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

    Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

    Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

    Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

    Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

    Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

    Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

    Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

    Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

    Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

    Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

    Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

    Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

    Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

    Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

    Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

    Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

    Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

    Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

    Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

    Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

    Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

    Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

    Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

    Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports

    J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

    Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies

    Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients

    Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test

    Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA VOYAGE Study in Children with Asthma

    Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe

    Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis

    Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)

    Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease

    Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study

    Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from VISIBLE OLE Study for Moderately to Severely Active Ulcerative Colitis

    Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab

    Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19

    Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use

    Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

    Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab

    Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE Study for Severe Crohn’s Disease

    Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab

    AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19

    Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials

    Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 Study for Moderately to Severely Active Crohn’s Disease

    Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya

    Pfizer’s Ibrance (palbociclib) Fails to Meet its Primary Endpoint in P-lll PENELOPE-B Study for Early Breast Cancer

    Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results

    Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

    Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab

    Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)

    The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.

    Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

    The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University.

    The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival.

    In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

    It’s hoped that this will hasten the process, which would take more than a year in normal conditions.

    Once the CHMP thinks there is enough data the company submits the complete filing, allowing the committee to reach a fast decision, which is passed on to the European Commission.

    The CHMP begun its review of the vaccine, known as BNT162b2 based on preliminary results from pre-clinical and early clinical studies.

    These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

    The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

    The RNA instructs the body to produce copies of the Spike protein found on the surface of the coronavirus, which produces an immune response and causes the body to neutralise the virus if it infects the body.

    BNT162b2 is being tested in a global phase 3 study ongoing at more than 120 clinical sites worldwide including the US, Brazil, South Africa and Argentina.

    To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

    According to latest figures from the World Health Organization, there are 42 potential COVID-19 vaccines in clinical development.

    It lists a candidate developed by China’s Sinovac as the most advanced, with AZ’s shot now fourth on the list after trials were temporarily halted because of a potential safety issue.

    Pfizer’s is further back on the list, although there are suggestions that it could be approved in the US in time for the presidential elections on 3rd November.

    US trials of AZ’s vaccine have not restarted while the FDA investigates the safety issue that caused the trials to be paused around a month ago.

    The post Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab appeared first on .

    GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development

    Shots:

    • NVIDIA reports that it is building the “Cambridge-1” supercomputer, which will be an NVIDIA DGX SuperPOD system capable of delivering 400+ petaflops of AI performance and 8 petaflops of Linpack performance and 1s expected to come online by the end of 2020
    • GSK and AstraZeneca will be the first company to harness Cambridge-1 for research. Additionally, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, and Oxford Nanopore Technologies also plan to take advantage of the system
    • Cambridge-1 will be the first NVIDIA supercomputer designed and built for external research access and will provide researchers and academics the ability to tackle challenging AI training, inference, and data science workloads at scale. NVIDIA will invest ~ $51.7M in Cambridge-1

    Click here ­to­ read full press release/ article | Ref: NVIDIA | Image: Medsmart App

    The post GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development first appeared on PharmaShots.

    Older people first to receive COVID-19 vaccine in UK, says government

    As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease.

    According to weekend press reports a rollout of a vaccine could be just three months away – but the feedback from the government is that not everyone will get it, with the target group being around 30 million older people and health workers, less than half the population of 67 million.

    Speaking to the Financial Times, the head of the country’s coronavirus vaccine task force Kate Bingham said that any vaccination programme will be targeted at the most vulnerable in society.

    She said: “People keep talking about ‘time to vaccinate the whole population’ but that is misguided.

    “There is going to be no vaccination of people under 18. It’s an adult-only vaccine for people over 50 focusing on health workers and care home workers and the vulnerable.”

    The strategy will likely be based on a draft list published last month by the government’s Joint Committee on Vaccine and Immunisation (JCVI), showing who is likely to be first to receive the vaccine.

    According to the JCVI a “simple age-based programme” will decide who gets priority, as this will allow the vaccine to get to those at highest risk at the fastest possible speed.

    Older adults in care homes and care home workers would be in the first group, followed by those aged over 80, over 75, over 70 and over 65.

    A sixth priority group would comprise of younger adults under 65 with conditions that leave them at high risk of developing serious complications from the virus.

    They would be followed by those aged under 65 who have a moderate risk level.

    Even distributing the vaccine to half the population will be a major logistical challenge, however, and the UK government is facing scrutiny and criticism over its handling of the pandemic so far.

    Flaws in the coronavirus reporting system emerged over the weekend when it emerged that nearly 16,000 cases had been missed in daily figures over the last week or so because of an IT error.

    The government has also been criticised for failing to implement a track and trace system early in the pandemic, a measure that limited its spread in other countries.

    Health secretary Matt Hancock has already said that the military may be brought in to help distribute the vaccine.

    Getting what could be the final stage of the fight against COVID-19 right will be vital if the government wishes to restore credibility, as millions continue to live under lockdown restrictions that have cost thousands of jobs and continue to damage the economy.

    The post Older people first to receive COVID-19 vaccine in UK, says government appeared first on .

    AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan

    Shots:

    • The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial
    • A standard review process triggered a voluntary pause to vaccination across all global trials on Sept 06, 2020, to allow the review of safety data by an independent committee
    • The resumption follows the restart of clinical study in the UK, Brazil, South Africa, and India

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Mint

    Related News: AstraZeneca Resumes COVID-19 Vaccine Trials in the UK

    The post AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan first appeared on PharmaShots.

    European regulators begin rolling review of AZ’s COVID-19 vaccine

    European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.

    It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take.

    Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”.

    The rolling review, which is designed to speed up the assessment of a promising vaccine or drug by the EMA’s CHMP scientific committee, will continue until there is enough evidence available to support a marketing authorisation.

    But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

    All that the agency has is preliminary data from pre-clinical and early clinical studies suggesting the vaccine triggers the production of antibodies and T-cells that target the virus.

    In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.

    Trials have already restarted in the UK, Brazil, South Africa and India after one patient in the UK developed a potential side-effect that was deemed serious enough to cause the trial to be paused.

    Discussions are still ongoing with the FDA, which has asked for further information before making a decision about resuming a trial in the US.

    AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

    It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus that that causes common cold infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

    After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

    The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on .

    Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

    Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

    UK doing more than most to help poor get Covid vaccine, study finds

    Campaign scoring countries for global access efforts calls for more British transparency

    The UK is doing more than most countries to support access to Covid vaccines for the poorest populations in the world, but it is not transparent enough about the deals it is doing at home, according to an international aid organisation launching a tracker.

    The One campaign has given countries and pharmaceutical companies scores for the efforts they have made to ensure the poorest get vaccines. In the vaccine access test no country or company scores green, the top rating, classed as aiding global access to vaccines.

    Continue reading…

    Oxford University resumes Covid-19 vaccine trials

    Trials of vaccine being developed with AstraZeneca had been paused after participant fell ill

    The closely watched trial of an experimental Covid-19 vaccine that was halted after a participant fell ill is to resume in the UK.

    The University of Oxford, which has partnered with pharmaceutical giant AstraZeneca to pilot the study, said that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had recommended that its trials resume after an independent committee review of safety data triggered a pause last week.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Continue reading…

    Show more empathy to boost confidence in vaccines, scientists told

    Expert behind vaccine confidence report points to halting of Oxford Covid trial as example

    Doctors and scientists need to show more empathy towards volunteers in coronavirus vaccine trials who fall ill if the public is to have full confidence in the safety of the vaccines being developed, say experts.

    The temporary halting of the Oxford University/AstraZeneca trial after one volunteer in the UK was admitted to hospital was good news, not bad, said Heidi Larson, who leads the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine, as it showed that scientists and the company were putting safety first.

    Continue reading…

    Oxford Covid-19 vaccine is still possible this year, says AstraZeneca chief

    Pharmaceutical firm’s boss says 2020 deadline possible if regulators move fast

    AstraZeneca’s coronavirus vaccine could still be available by the end of the year, or early next year, according to the company’s chief executive, Pascal Soriot, despite clinical trials being paused after a volunteer fell ill.

    AstraZeneca and Oxford University, which are jointly developing the vaccine and testing it on 50,000 to 60,000 people around the world, halted trials on Wednesday to investigate the “potentially unexpected illness” of one participant.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Continue reading…

    Oxford Covid vaccine trial suspension: what happens next?

    Tests have been paused after a UK volunteer became ill. How will it affect the search for a cure?

    One of the volunteers in the UK has become ill and it is crucial that the researchers find out whether this could be related to the vaccine. This is not uncommon in vaccine trials – and in fact it is said to be the second time it has happened with this vaccine . Very large trials are essential to pick up any rare side-effects. Something that affects one in 10,000 people, for instance, will probably not be detected in the early trials of just a few thousand.

    Continue reading…

    Oxford University Covid vaccine trial put on hold due to possible adverse reaction in participant

    A spokesman for AstraZeneca, the company working on the coronavirus vaccine, said pausing trials was common during vaccine development

    The development of a promising Covid-19 vaccine has been put on hold due to a possible adverse reaction in a trial participant.

    A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian the trial has been stopped to review the “potentially unexplained illness” in one of the participants.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Related: Let’s get real. No vaccine will work as if by magic, returning us to ‘normal’ | Jeremy Farrar

    Continue reading…

    AstraZeneca expands Covid-19 vaccine deal as final trials begin

    UK drugmaker and Oxford Biomedica to produce more of potential coronavirus product

    AstraZeneca has expanded an agreement with Oxford Biomedica to scale up production of its potential Covid-19 vaccine, as the race continues to find an effective prevention for the deadly virus.

    Under the supply agreement, the Oxford-based cell and gene therapy firm said it would produce tens of millions of doses of AstraZeneca’s potential vaccine, AZD1222, for 18 months, which could be extended by a further 18 months into 2023.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Continue reading…

    PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

    1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

    Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis

    2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

    Published: Aug 28, 2020 | Tags:  Bayer, Reports, NDA, Submission, NMPA, Chronic Heart Failure, China, Vericiguat

    3. Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

    Published: Aug 27, 2020 | Tags: Galecto, GB0139, Receives, US, FDA, EMA, Orphan Drug Designations, Idiopathic Pulmonary Fibrosis

    4. Philips to Acquire Intact Vascular for $360M

    Published: Aug 27, 2020 | Tags: Philips, Acquire, Intact Vascular, $360M

    5. BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

    Published: Aug 27, 2020 | Tags: BioNTech, Fosun Pharma,  Supply, ~10M, Doses, COVID-19 Vaccine, Hong Kong, Macao

    6. Amazon Enters into Fitness Space with the Launch of Halo Band and App

    Published: Aug 27, 2020 | Tags: Amazon, Enters, Fitness Space, Launch, Halo Band

    7. BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

    Published: Aug 27, 2020 | Tags: BeiGene, Signs, Exclusive, License Agreement, Singlomics, Neutralizing, COVID-19, Antibodies

    8. Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect COVID-19

    Published: Aug 27, 2020 | Tags: Abbott, BinaxNOW COVID-19 Ag Card, Receives, US, FDA, EUA, Detect, COVID-19

    9. FDC Launches Two Variants of Favipiravir for COVID-19 in India

    Published: Aug 26, 2020 | Tags:  FDC, Launches, Two Variants, Favipiravir, COVID-19, India

    10. Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

    Published: Aug 26, 2020 | Tags:  Celltrion, Initiates, P-I, Study, CT-P59, COVID-19, Korea

    11. GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

    Published: Aug 26, 2020 | Tags:  GSK, Blenrep, (belantamab mafodotin), Receives, EC’s, Approval, R/R, Multiple Myeloma

    12. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

    Published: Aug 26, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

    13. Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

    Published: Aug 26, 2020 | Tags: Takeda, Collaborates, Engitix, Target, Fibrotic Liver Diseases

    14. Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

    Published: Aug 25, 2020 | Tags: Philips, B. Braun, Onvision Needle Tip Tracking Technology, Receive, US, FDA, 510 (k) Clearance, Regional Anesthesia

    15. Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

    Published: Aug 25, 2020 | Tags: Qiagen, Launch, Digital Test, Detecting, SARS-CoV-2, Antibodies, US

    16. Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

    Published: Aug 26, 2020 | Tags: Novartis, Reports, Results, Asciminib, (ABL001), P-III, ASCEMBL Study, Chronic Myeloid Leukemia

    17. Takeda and OVID Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

    Published: Aug 25, 2020 | Tags: Takeda, OVID, Report, Results, Soticlestat, TAK-935/OV935, P-II, ELEKTRA Study, Dravet Syndrome, Lennox-Gastaut Syndrome

    18. ACADIA Acquires CerSci Therapeutics for $52.5M

    Published: Aug 25, 2020 | Tags: ACADIA, Acquires, CerSci Therapeutics, $52.5M

    19. AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

    Published: Aug 25, 2020 | Tags: AbbVie, Harvard University, Collaborate, Develop, Novel Therapies, Against, Emergent Viral Diseases

    20. AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

    Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease

    21. BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

    Published: Aug 24, 2020 | Tags: BeiGene, Signs, License, Supply, Agreement, Bio-Thera, BAT1706, biosimilar, bevacizumab, China

    22. AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

    Published: Aug 25, 2020 | Tags: AstraZeneca, Initiates, P-I, Study, AZD7442, Against, COVID-19

    23. Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

    Published: Aug 24, 2020 | Tags: Merck, Keytruda, (pembrolizumab), Receives, PMDA, Approvals, Japan

    24. Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

    Published: Aug 24, 2020 | Tags: Bionano, Genomics, Acquires, Lineagen, Facilitate, Clinical Adoption, Saphyr, Digital Cytogenetics

    26. Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

    Published: Aug 24, 2020 | Tags:  Bayer, One Drop, Collaborate, Develop, Digital Therapies, Across, Multiple, Therapeutic Areas

    27. BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

    Published: Aug 24, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

    28.  Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

    Published: Aug 23, 2020 | Tags: Novartis, Triple Regimen, Fails, Meet, Primary Endpoint, P-III, COMBI-I, Study, Advanced Melanoma

    29. ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

    Published: Aug 24, 2020 | Tags: ReiThera, Reports, First, Patient Dosing, COVID-19, Vaccine Candidate, Italy

    30. Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

    Published: Aug 24, 2020 | Tags:  Takeda, Divest, Consumer Health Unit, Blackstone,  $2.3B, Japan

    31. Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

    Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer

    32. Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

    Published: Aug 22, 2020 | Tags: Vertex, Kaftrio, Ivacaftor, Receive, EC, Approval, Cystic Fibrosis, Aged, 12 Years, Older

    32. AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

    Published: Aug 22, 2020 | Tags: AstraZeneca, Collaborates, RenalytixAI, Develop, Precision Medicine, Chronic Diseases

    Insights+: The US FDA New Drug Approvals in July 2020

    The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 8 new drugs approved by the US FDA in July 2020.

    1.Acacia Pharma’s Byfavo (remimazolam) Received the US FDA’s Approval for the Induction and Maintenance of Procedural Sedation

    Published: Jul 02, 2020 | Tags: Acacia Pharma, Byfavo, remimazolam, Received, the US FDA, Approval, Induction, Maintenance, Procedural Sedation

    • The safety of Byfavo was evaluated in 969 patients assessing Byfavo for the induction and maintenance of procedural sedation
    • In Jan 2020, the company in-licensed the commercial rights to Byfavo and will pay $33.6M upfront generated by the approval, consisting of $16.8M in cash and $16.8M in ordinary shares of Acacia Pharma stock. Additionally, Acacia will get $11.2M net cash to launch the product in the US
    • Byfavo (remimazolam) is an injection rapid onset/offset IV benzodiazepine sedative for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with its expected launch in the US in H2’20

    2. Osmotica’s Upneeq Received the US FDA’s Approval to Treat Blepharoptosis (Droopy Eyelid) in Adults

    Published: Jul 09, 2020 | Tags: Osmotica, Upneeq, Received, the US FDA, Approval, Treat, Blepharoptosis, Droopy Eyelid, Adults

    • The approval was based on P-III trial assessing Upneeq vs PBO in a (2:1) ratio in 140 patients with acquired blepharoptosis split into two treatment groups for 42 days. Additionally, another second P-III clinical trial evaluated the safety and efficacy of Upneeq vs PBO in 35 patients to treat acquired blepharoptosis
    • The study resulted in well-tolerated results when administered once daily over a six-week period with no serious AEs and met its both 1EPs and 2EPs, mean change from baseline on the LPFT on Hour 6, Day 1 6.3 vs 2.1, Hour 2 Day 14 7.7 vs 2.4, improvement in MRD-1 at 5 and 15 minutes, and 2 and 6 hours post-dose on days 1 and 14
    • Upneeq (oxymetazoline hydrochloride ophthalmic solution) is a QD ophthalmic formulation of oxymetazoline and an alpha-adrenergic receptor agonist a novel pharmacologic treatment indicated for the treatment of acquired blepharoptosis

    3. Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval to MDS and CMML

    Published: Jul 20, 2020 | Tags: Otsuka, Inqovi, decitabine, cedazuridine, Received, the US FDA, Approval, MDS, CMML

    • The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine
    • Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval
    • Inqovi is a novel product orally administered hypomethylating agent approved by the US and Health Canada for the treatment of MDS and CMML

    4. Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Received the US FDA’s Approval for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

    Published: Jul 22, 2020 | Tags: Jazz Pharmaceuticals, Xywav, Calcium, magnesium, potassium, sodium oxybates, Received, the US FDA, Approval, Cataplexy, Excessive, Daytime, Sleepiness, Associated, Narcolepsy

    • The FDA approval was based on P-III study results assessing Xywav vs PBO in 201 patients to evaluate the safety and efficacy in the treatment of cataplexy and EDS in patients with narcolepsy 
    • The study resulted in statistically significant differences in the weekly number of cataplexy attack and Epworth Sleepiness Scale scores
    • Xywav, also known as JZP-258 is targeted for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Additionally, the USDEA (Drug Enforcement Administration) has designated Xywav as a Schedule III medicine also contains a boxed warning of as a central nervous system depressant

    5. MC2 Therapeutics Wynzora Cream Received the US FDA’s Approval to Treat Plaque Psoriasis in Adults

    Published: Jul 22, 2020 | Tags: MC2 Therapeutics, Wynzora Cream, Received, the US FDA, Approval, Treat, Plaque Psoriasis, Adults

    • The approval was based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
    • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
    • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

    6. AstraZeneca’s Breztri Aerosphere Received the US FDA’s Approval for the Maintenance Treatment of COPD

    Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Received, US, FDA, Approval, Maintenance Treatment, COPD

    • The approval was based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with moderate to severe COPD and a history of exacerbation(s) in the previous year
    • The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
    • Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

    7. MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Received the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

    Published: Jul 31, 2020 | Tags: MorphoSys, Monjuvi, tafasitamab-cxix, Lenalidomide, Received, US, FDA, Approval, 2L, Treatment, Patients, Relapsed, Refractory, Diffuse Large B-cell Lymphoma

    • The approval was based on P-II L-MIND study assessing Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL
    • Results: ORR (55%); CR (37%); PR (18%); mDOR (21.7mos.). Additionally, the US FDA has granted BT designation for the combination therapy for r/r DLBCL
    • Monjuvi is a humanized Fc-modified cytolytic CD19 targeting mAb, has been approved under US FDA’s accelerated approval, and is expected to be commercially available in the US. MorphoSys and Incyte will co-commercialize Monjuvi in the US & has exclusive commercialization rights outside the territory

    8. ViiV Healthcare’s Rukobia (fostemsavir) Received the US FDA’s Approval for HIV in Patients with Limited Treatment Options

    Published: Jul 31, 2020 | Tags:  ViiV Healthcare, Rukobia, fostemsavir, Received, US, FDA, Approval, HIV, Patients, Limited Treatment Options

    • The approval was based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
    • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively. In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively
    • Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

    AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19

    The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar to that of Regeneron and Roche with their drug, REGN-COV2.

    Best not to look like your passport photo | Brief letters

    AstraZeneca | Sizes of cities | Starlings | Mickey Mouse degrees | Passport photos

    As a participant in the Oxford University Covid-19 vaccine trial, I’d be put out if AstraZeneca rushed through a deal with Donald Trump in time for the US presidential election (Oxford University Covid-19 vaccine firm says it is not in talks with Trump, 24 August). AstraZeneca must issue a less ambiguous rebuttal of the reports of such a deal. If it doesn’t, I’ll withdraw from the trial.
    Paddy Clark
    Chiddingfold, Surrey

    • Britain’s most populous city in its own right is in fact Birmingham (Letters, 24 August). While Greater London is Britain’s biggest urban area, only the City of London and Westminster have city status. Manchester comes fourth (after Leeds and Sheffield), though this may depend on which boroughs you include – not Salford, surely?
    Matthew J Smith
    New Malden, London

    Continue reading…

    Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail

    The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections.

    The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile. It will enrol up to 48 people aged 18 to 55, and is expected to generate results before the end of the year.  

    AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.

    The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June. In animal and human cell models, the cocktail has been shown to block the binding of the SARS-CoV-2 virus to host cells and protect against infection.

    The rationale behind the drug is the same as Regeneron’s REGN-COV2 antibody cocktail, which is further ahead in development having started phase 3 testing in early July, with preliminary data expected in the coming weeks.

    REGN-COV2 advanced into phase 2/3 on the strength of a single phase 1 study, and the US government has already agreed a deal to scale up manufacturing and claim the first doses to be made.

    Regeneron’s drug is being tested as a single intravenous dose in the treatment of established COVID-19, and as a subcutaneous dose in prevention studies involving household contacts of people infected with the coronavirus. A recently-started trial of the antibody is looking at a dosing frequency for subcutaneous injections of every four weeks.

    Mene Pangalos, head of biopharmaceuticals R&D at AZ, says that AZD7442 has been developed using a half-life extension technology that “has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance.”

    The half-life extended antibodies should afford at least six months of protection from COVID-19, according to AZ. If that profile is backed up in clinical testing it could mean that supplies of AZD7442 – which could be limited initially – will stretch further.

    The FDA has just granted emergency use authorisation to the use of convalescent plasma to treat severe COVID-19 cases in the US – notably despite reservations among some health experts.

    However, there are advantages to having off-the-shelf, standardised antibodies such as REGN-COV2 and AZD7442 that have been tested clinically and may reduce the risk of side effects.

    Another approach that avoids the use of plasma itself was proposed by a group of companies that specialise in plasma-derived drugs back in April.

    Led by Takeda and CSL Behring, the consortium – which also includes Biotest, BPL Group, LFB and Octapharma – is working on an “unbranded” hyperimmune immunoglobulin drug for SARS-CoV-2.

    The post Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail appeared first on .

    AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

    Shots:

    • The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA
    • If AZD7442 proves to be tolerated and has a favorable safety profile in the trial, AstraZeneca will progress it into larger P-II & P-III trials to evaluate its efficacy as a preventative and treatment approach against COVID-19. The company anticipates the results of P-I study in H2’20
    • AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection, discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in Jun’2020. AstraZeneca optimized the mAbs with half-life extension and reduced Fc receptor binding

    Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Outsourcing Pharma

    AstraZeneca starts Covid-19 antibody drug trial in UK

    Volunteers are receiving doses of drug, which has potential both as a vaccine and a treatment

    The pharmaceutical group AstraZeneca has started a clinical trial of a drug to help prevent and treat Covid-19, with the first volunteers already receiving doses.

    The company, which is separately developing a potential Covid-19 vaccine together with scientists at Oxford University, said the drug, known as AZD7442, is a combination of two monoclonal antibodies.

    Continue reading…

    Oxford University Covid-19 vaccine firm denies Trump talks

    AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US

    The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.

    With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.

    Related: Covid vaccine tracker: when will we have a coronavirus vaccine?

    Continue reading…

    AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

    Shots:

    • The two companies will develop and launch precision medicine strategies for CV, renal, and metabolic diseases. The first stage in the collaboration will use KidneyIntelX to improve outcomes for patients with CKD and its complications, in coordination with the Mount Sinai Health System
    • The first stage will assess the impact of AI-enabled in vitro diagnostic solutions to optimize the utilization of therapies in CKD under current SOC protocols. The study will evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia with its anticipated results in 2021
    • The studies will be conducted in coordination with the Mount Sinai Health System, where KidneyIntelX testing and care management software are currently being deployed for commercial clinical use

    Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Renalytixa

    PharmaShots Weekly Snapshot (Aug 17 -21 2020)

    1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

    Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia

    2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China

    Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, Senaparib, IMP4297, China

    3. The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R MM

    Published: Aug 20, 2020 | Tags: US, FDA, Approves, Kyprolis, carfilzomib, Darzalex, (daratumumab), Dexamethasone, Two Dosing, Regimens, RRMM

    4. AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

    Published: Aug 21, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, MHLW, Approval, Extensive-Stage, Small Cell lung Cancer

    5.  Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

    Published: Aug 20, 2020 | Tags: Pfizer, BioNTech, Regulatory Review, COVID-19, Vaccine,  October, 2020

    6. Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis 

    Published: Aug 20, 2020 | Tags: Novartis, Kesimpta, (ofatumumab), Receives, US ,FDA, Approval, First, Self-Administered Therapy, Relapsing, Multiple Sclerosis

    7. Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

    Published: Aug 20, 2020 | Tags: Evotec, Centogene, Expand, Collaboration, Target, Gaucher Disease

    8. BioSymetrics Signs an Agreement with Janssen and Sema4 to Utilize AI for the Prediction of COVID-19

    Published: Aug 19, 2020 | Tags: BioSymetrics, Signs, Agreement, Janssen, Sema4, Utilize AI, COVID-19

    9. Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

    Published: Aug 19, 2020 | Tags:  Precision BioSciences, Receives, US, FDA, Fast Track Disease Designation, PBCAR0191, Treat, Advanced, B-cell Precursor Acute Lymphoblastic Leukemia

    10. Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

    Published: Aug 18, 2020 | Tags:  Qiagen, Launches, QIAseq SARS-CoV-2, Primer Panel, Tracking, COVID-19, Mutations, Strains

    11. Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19

    Published: Aug 19, 2020 | Tags:  Sorrento, Files, IND, STI-1499, COVI-GUARD, Patients, Hospitalized, COVID-19

    12. Fitbit Reports Results of its COVID-19 Study for Early Detection of Diseases

    Published: Aug 19, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

    13. Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

    Published: Aug 19, 2020 | Tags: Roche, Tecentriq, Bevacizumab, Receive, Health Canada, Approval, 1L, Treatment,  Unresectable,  Metastatic, Hepatocellular Carcinoma

    14. The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues   

    Published: Aug 19, 2020 | Tags: The US, FDA, Rejects, Gilead, Filgotinib, Toxicity Issues

    15. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

    Published: Aug 19, 2020 | Tags: Johnson & Johnson, Acquire, Momenta Pharmaceuticals,  $6.5B

    16. Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

    Published: Aug 18, 2020 | Tags: Sanofi, Dupixent, dupilumab, Receives,  Health Canada, Approval,  Severe, Chronic Rhinosinusitis,  Nasal Polyposis

    17. Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease 

    Published: Aug 18, 2020 | Tags: Novo Nordisk, Collaborates, Evotec, Develop Therapies, Targeting, Chronic Kidney Disease

    18. Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

    Published: Aug 19, 2020 | Tags: Regeneron, Collaborates, Roche, Improve, Global Supply, REGN-COV2, Against, COVID-19

    19. Lilly and Innovent Report the Global Expansion of their Alliance for Tyvyt (sintilimab)

    Published: Aug 18, 2020 | Tags: Lilly, Innovent, Report, Global Expansion, Alliance, Tyvyt, sintilimab

    20. G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

    Published: Aug 17, 2020 | Tags: G1 Therapeutics, Reports, US, FDA, Acceptance, Priority Review, NDA, Trilaciclib, SCLC

    21.PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

    Published: Aug 17, 2020 | Tags: PTC, Reports, EMA, Acceptance, MAA, Evrysdi, risdiplam, SMA

    22. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B   

    Published: Aug 17, 2020 | Tags: Gilead, Expand, Oncology Collaboration, Tango, $6.3B

    23. AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

    Published: Aug 19, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, US, FDA, Priority Review, Less Frequent, Fixed-Dose Use, NSCLC, Bladder Cancer

    24. AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

    Published: Aug 17, 2020 | Tags: AstraZeneca, Collaborates, mAbxience, Produce, Covid-19, Vaccine, Latin America

    26. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

    Published: Aug 17, 2020 | Tags:  Gilead, Expand, Oncology Collaboration, Tango, Worth, ~$6.3B

    27. Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

    Published: Aug 17, 2020 | Tags: Roche, Enspryng, (satralizumab-mwge), Receives,  US, FDA, Approval,  Neuromyelitis Optica Spectrum Disorder

    28. Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

    Published: Aug 17, 2020 | Tags: Henlius, HLX02, Receives, NMPA, Approval, First, Trastuzumab, Biosimilar, China

    29.Abeona Signs a License and Inventory Purchase Agreements with Taysha for ABO-202 to Treat CLN1 Disease (Infantile Batten disease)

    Published: Aug 17, 2020 | Tags: Abeona Therapeutics, Signs, License, Inventory Purchase, Agreements, Taysha Gene Therapies, ABO-202, CLN1 Disease

    30.BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

    Published: Aug 17, 2020 | Tags:  BMS, Signs, Exclusive, Worldwide, License Agreement, Dragonfly Therapeutics, DF6002

    31. Sanofi to Acquire Principia Biopharma for ~$3.68B

    Published: Aug 17, 2020 | Tags: Sanofi, Acquire, Principia Biopharma, $3.68B

    AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

    Shots:

    • The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w until disease progression
    • Results: the study met its 1EPs of OS in Jun’2019, demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs., m-OS (12.9 vs 10.5 mos.)
    • Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products

    AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

    Shots:

    • The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC
    • The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials, including results of P-III CASPIAN trial in ES-SCLC which used the 4wks., FD regimen during maintenance
    • If approved, the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w

    Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Fierce Pharma

    Related News: AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

    AZ aims to cut cancer clinic visits with new Imfinzi regimen

    The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients with lung and bladder cancer.

    The regulator has granted a faster six-month Priority Review for the fixed dose regimen, based on data from several Imfinzi clinical trials, including results from the phase III CASPIAN trial in extensive stage small-cell lung cancer (ES-SCLC) which used the four-week, fixed-dose regimen during maintenance.

    AZ hopes that the new dosing regimen will be able to offer patients and doctors an alternative to the existing fortnightly regimen, allowing the drug to gain traction and taking pressure off clinics during the COVID-19 pandemic.

    The strategy is similar to one employed by Merck & Co, which has extended the length of the dosing regimen for its rival immunotherapy Keytruda from three to six weeks in certain indications.

    The FDA grants Priority Review to applications for medicines that offer significant advances over available options for serious diseases in terms of safety, efficacy preventing serious conditions, or patient compliance.

    Cutting the number of visits to clinics is an important factor in getting patients to comply with regimens, saving on travel costs and reducing the impact on patients’ lives.

    A regulatory decision is due during the fourth quarter of 2020.

    Dave Fredrickson, executive vice president at AstraZeneca’s oncology unit, said: “The new less-frequent dosing option for non-small cell lung cancer and bladder cancer will simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting.

    “This takes on particular urgency during the current pandemic, as doctors care for patients at high risk of COVID-19 complications.”

    Imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on the phase 3 PACIFIC trial.

    Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.

    It is also approved in the US and under review in Japan and other countries for ES-SCLC. Imfinzi was also recently recommended for marketing authorisation in the EU for this indication.

    The post AZ aims to cut cancer clinic visits with new Imfinzi regimen appeared first on .

    AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

    Shots:

    • mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil
    • The company will produce API in its facility located in Garín (Argentina) and will send it to Mexico to complete the production and filling process. AstraZeneca will transfer its technology to the Garín plant shortly, allowing the facility to produce the vaccine in the coming months
    • AstraZeneca’s AZD1222 has demonstrated robust immune response in its P-I & II studies, being evaluated in P-III study with its expected completion in the coming months. The vaccine is expected to be available in the H1’21, upon completion of the P-III trial and approval

    Click here ­to­ read full press release/ article | Ref: mAbxience | Image: Thailand Medical News

    Related News: AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

    EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

    The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million.

    ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing.

    The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

    The order comes after the Commission put agreements in place for the supply of two other vaccines – from Johnson & Johnson and Sanofi/GlaxoSmithKline – that will be activated if the shots prove their worth in clinical trials.

    Those deals cover 200 million doses of J&J’s Ad26.COV2.S – with an option on another 200 million – and 300 million doses of the Sanofi/GSK candidate. Meanwhile, the EC is also talking to Pfizer/BioNTech, Moderna and CureVac about access to their COVID-19 shots.

    There are concerns that the scale of the deals – which comes after a series of similar big orders from the US and other national governments – could make accessing supplies more difficult for organisations such the WHO and GAVI, which are aiming to supply less affluent countries.

    Reuters says that the Commission has “urged EU states to shun the WHO-led initiative because it sees it as too expensive and slow.”

    The EU is now suggesting that it could use a portion of its vaccine orders to supply countries elsewhere in the world, which could be viewed as stepping on the toes of these non-governmental organisation (NGO) initiatives.

    “We will continue to work tirelessly to bring more candidates into a broad EU vaccines portfolio,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, adding that a vaccine “remains the surest exit strategy to protect our citizens and the rest of the world from the coronavirus.”

    The advance order will be financed using the EU’s Emergency Support Instrument, a €2 billion fund set aside to cover purchases of vaccines, drugs and other goods needed to fight the coronavirus epidemic.

    The fund has already been deployed to order Gilead’s antiviral drug Veklury (remdesivir) and apheresis equipment to collect antibodies from the blood of patients who have recovered from COVID-19.

    Last month, interim results from a phase 1/2 trial of ChAdOx1  were published in The Lancet and showed the jab was tolerated and generated immune responses against the SARS-CoV-2 virus in all vaccinated participants.

    It is based on an adenoviral vector formed on a weakened version of the adenovirus that causes a common cold-line illness in chimpanzees, containing the genetic material of SARS-CoV-2 spike protein.

    AZ said that it has now signed supply deals for around 3 billion doses of the vaccine, with Russia, South Korea, Japan, China, Latin America and Brazil also placing orders.

    The post EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine appeared first on .