NICE rejects BMS’ Zeposia MS pill in provisional guidance

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance.

The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a).

But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.

NICE also noted the range of other disease-modifying drugs already available, oral rivals Novartis’ Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) from Biogen.

There are also some powerful injected drugs on the market such as Roche’s Ocrevus (ocrelizumab), Sanofi’s Lemtrada (alemtuzumab).

In its guidance, NICE did not give details of cost-effectiveness estimates because of confidential commercial arrangements for Zeposia and comparators.

But NICE said that the drug was likely to fall outside its cost-effectiveness threshold of £30,000 per Quality Adjusted Life Year (QALY).

There was also no analysis supporting Zeposia’s use as a second-line treatment.

Along with other technical data, NICE said it wanted to see data comparative with other second line treatments such as Lemtrada and Gilenya.

In a statement, the MS Society said it was “frustrating” that NICE had decided not to recommend funding for Zeposia.

Dr Sara Rawlings, director of research and external affairs at the MS Society said: “While there are a range of treatments for this form of the condition, oral options are limited, and people could benefit enormously from a new, more convenient alternative.

“NICE’s decision isn’t final, and we are urging them and the manufacturer to review the evidence and consider what’s best for those living with MS. Ozanimod would be the only oral first-line treatment for some people with relapsing MS, and we are hopeful both sides will act on the significance of this.”

Zeposia is important to patients because it doesn’t cause the unpleasant gastrointestinal side effects associated with Biogen’s Tecfidera.

Rawlings pointed out that there is still time for NICE to change its mind if BMS submits new evidence.

The guidance applies only to England and Wales and in most cases Northern Ireland. A decision is expected from the Scottish Medicines Consortium next month.

The post NICE rejects BMS’ Zeposia MS pill in provisional guidance appeared first on .

Insights+: The US FDA New Drug Approvals in December 2020

The US FDA has approved 7 NDAs and 2 BLA in Nov 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 105 novel products so far in 2020, including 9 in Dec 2020.  

Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 9 new drugs approved by the US FDA in Dec 2020. 

The US FDA Approved Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer 

Published: Dec 01, 2020 | Tags: US, FDA, Approves, Gallium 68 PSMA-11, PET imaging, PSMA Positive Lesions, Men, Prostate Cancer 

  • The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled 635 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans and who had rising serum PSA levels after initial prostate surgery or radiotherapy  
  • 74% of patients had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region  
  • Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an IV injection. The approval is granted to the University of California  

Vanda’s Hetlioz (tasimelteon) Received the US FDA’s Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome  

Published: Dec 01, 2020 | Tags: Vanda, Hetlioz, tasimelteon, US, FDA, Approval, Treatment, Nighttime Sleep Disturbances, Smith-Magenis Syndrome 

  • The approval is based on study assessing Heltioz vs PBO in both adults with SMS taking the capsule formulation and children with SMS taking the liquid formulation. The safety profile of the therapy is in consistent with previous study conducted for the treatment of Non-24-Hour Sleep-Wake Disorder 
  • Hetlioz capsules will available imminently for adults and Hetlioz LQ liquid formulation for children is expected to be available in Q1’21  
  • Hetlioz is melatonin receptor agonist & is an approved therapy in the US & EU 

Roche’s Gavreto (pralsetinib) Received the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers 

Published: Dec 02, 2020 | Tags:  Roche’s, Gavreto, (pralsetinib), Receives, US FDA’s Approval, Advanced or Metastatic RET-Mutant, RET Fusion-Positive Thyroid Cancers 

  • The approval is based on P-I/II ARROW study involve the assessing Gavreto (400mg, qd) n people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors 
  • The study demonstrated durable clinical activity in people with/out prior therapy and regardless of RET alteration genotypes 
  • Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations  

Biocryst’s Orladeyo (berotralstat) Received the US FDA’s Approval to Prevent Attacks of Hereditary Angioedema (HAE) 

Published: Dec 03, 2020 | Tags: Biocryst, Orladeyo, (berotralstat), Receives, US, FDA, Approval, hereditary angioedema (HAE) 

  • The approval is based on a pivotal P-III APeX-2 trial assessing Orladeyo (150 mg, qd) in adults and pediatric patients aged ≥12yrs. with HAE 
  • The study demonstrated reduction attacks @24wks. while the reduction was sustained through 48wks. with mean HAE attack rates of 2.9 attacks/mos. In the long-term open-label APeX-S trial, patients completing 48wks. of therapy had a mean attack rate of 0.8 attacks/mos. 
  • Orladeyo (PO) is designed specifically to prevent attacks of HAE in adults and pediatric patients aged ≥12yrs 

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

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

  • The approval is based on P-III studies KX01-AK-003 and KX01-AK-004 that evaluated the efficacy and safety of Klisyri (tirbanibulin, ointment 1%, 10 mg/g) vs vehicle in 702 adult patients in the ratio of (1:1) with actinic keratosis of the face or scalp  
  • Both the studies achieved their 1EPs defined as 100% clearance of the AK lesions @57 days within the treatment areas, complete clearance (44% vs 5% and 54% vs 13%) respectively  
  • Klisyri is the first FDA approved product for Athenex and will be launched in partnership with Almirall in the US during Q1’21  

Myovant’s Orgovyx (relugolix) Received the US FDA’s Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer 

Published: Dec 15, 2020 | Tags: Myovant, Orgovyx, (relugolix), Advanced Prostate Cancer 

  • The approval is based on a P-III HERO study assessing Relugolix (360mg loading dose followed by 120mg, qd) vs leuprolide acetate (3mos. depot injection) in patients with advanced prostate cancer. The therapy is expected to be available in Jan’2021 
  • Results: met its 1EPs, sustained testosterone suppression to castrate levels (< 50 ng/dL) @48wks. (96.7% vs 88.8%).  
  • 2EPs include @day4 & 15 suppression of testosterone to castrate levels (56% & 99% vs 0% & 12%); profound suppression of testosterone (< 20 ng/dL) @day15 (78% vs 1%); reduction in PSA by 65% @day15 and by 83% @day 29 

MacroGenics’ Margenza (margetuximab-cmkb) Received the US FDA’s Patients with Pretreated Metastatic HER2-Positive Breast Cancer 

Published: Dec 16, 2020 | Tags: MacroGenics, Margenza, Receives, US, FDA, Metastatic, HER2-Positive Breast Cancer 

  • The approval is based on P-III SOPHIA trial involves assessing of Margenza (IV, 15 mg/kg, q3w) vs Herceptin (trastuzumab, IV, 6mg/kg or 8mg/kg for loading dose) both combined with CT in 536 patients in a ratio (1:1) with HER2-positive m-BC who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.  
  • The study showed 24% reduction in the risk of disease progression or death, ORR (22% vs 16%), The final OS analysis is expected in the H2’21  
  • Margenza is an Fc-engineered, mAb that targets the HER2 oncoprotein, also being evaluated in multiple trials for HER2+ gastroesophageal cancer & various HER2+ tumors 

Ridgeback’s Ebanga (mAb114) Received the US FDA’s Approval for the Treatment of Ebola 

Published: Dec 22, 2020 | Tags: Ridgeback, Ebanga, mAb114, Receives, US, FDA, Approval, Ebola 

  • Ebanga is now approved for treatment of infection caused by Zaire ebolavirus in adult & pediatric patients (including neonates born to a mother who is RT-PCR+ for Zaire ebolavirus infection) 
  • The efforts of the PALM study demonstrated Ebanga’s safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history 
  • In 2020, Ridgeback initiated a compassionate use protocol for Ebola patients during the DRC’s 11th Ebola outbreak in Équateur Province and will provide it to all PCR+ Ebola patients under the protocol 

Urovant’s Gemtesa (vibegron) Received the US FDA’s Approval for Overactive Bladder  

Published: Dec 23, 2020 | Tags: Urovant, Gemtesa, Vibegron, US, FDA, Approval, Treatment, Overactive Bladder, OAB 

  • The approval is based on P-III EMPOWUR and EMPOWUR long term extension study that involves assessing Gemtesa (75mg, qd) vs PBO in ~4000 patients with OAB for 12wks. 
  • The study resulted in reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided 
  • Gemtesa is a small-molecule β3 adrenergic receptor agonist therapy that relaxes the detrusor bladder muscle so that the bladder can hold more urine, thus reducing symptoms of OAB. Gemtesa is the first oral branded FDA’s approved OAB medication since 2012, and it is the first product approval for Urovant Sciences 

Related Post: Insights+: The US FDA New Drug Approvals in November 2020

The post Insights+: The US FDA New Drug Approvals in December 2020 first appeared on PharmaShots.

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots:

  • The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021
  • Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD are in favor of Esbriet. Additionally, less loss to lung function and exercise capacity was observed
  • Esbriet is an oral therapy for IPF and is available in more than 60+ countries globally. FDA has granted ODD and BTD to the therapy in 2020

Click here ­to­ read full press release/ article | Ref: Roche| Image: The Indian Express

The post Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD first appeared on PharmaShots.

Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE backed the drug in England.

Rozlytrek (entrectinib) can now be used by the NHS in Scotland as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

ROS1 is a rare mutation found in fewer than 2% of NSCLC cases, and patients have few treatment options, especially when the disease has spread to the brain. NICE has previously estimated that roughly 412 patients across the UK are have NSCLC eligible for treatment with Rozlytrek.

The SMC cleared Rozlytrek via its Patient and Clinician Engagement (PACE) programme, a mechanism that brings agency reviewers, clinicians and patient group representatives together in order to discuss benefits of a medicine that may not be fully captured in the conventional appraisal process.

In the meeting, patients and clinicians said ROS1-positive NSCLC is often diagnosed at an advanced stage, so is associated with a short life expectancy, and there are limited treatment options available.

“This type of advanced NSCLC is a very rare and incurable lung cancer that often occurs in non-smokers and affects many under 60 years old,” commented Gemma Boni, head of lung cancer at Roche Products Ltd.

“Our commitment is to ensure that people in Scotland with lung cancer live longer and healthier lives, and today’s news shows how we are advancing science to achieve this,” she added.

In 2018, Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) was cleared by NICE in England – via the Cancer Drugs Fund (CDF) – as well as in Scotland by the SMC as a first-line option for treating ROS1-positive advanced NSCLC in adults.

Second-line treatment options include pemetrexed with carboplatin or other platinum doublet chemotherapy, with pemetrexed as a maintenance therapy.

Rozlytrek is also approved to treat people aged 12 years of age and older with solid tumours that have an NTRK gene fusion – regardless of where they appear in the body – and the SMC should decide whether that use is cost effective in the next couple of months. NICE has already approved Rozlytrek for that use in England via the CDF.

Other decisions

The SMC also backed NHS use for four other medicines in its January update, including Janssen’s Darzalex (daratumumab) for adults with newly-diagnosed multiple myeloma who are eligible for autologous stem cell transplant. NICE is due to deliver a verdict on this use for the drug in April.

Meanwhile, Rigel Pharmaceuticals’ Tavlesse (fostamatinib) – sold by Spain’s Grifols in Europe – can now be used in Scotland to treat chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. NICE is also conducting an appraisal of Tavlesse, but hasn’t yet set a timeframe for review.

Also backed were Takeda’s Adcetris (brentuximab vedotin) for systemic anaplastic large cell lymphoma (sALCL) – a use already approved by NICE in England – and Novartis’ Cosentyx (secukinumab) for non-radiographic axial spondyloarthritis which NICE expects to decide on in May.

The SMC rejected RAD Neurim Pharma’s Slenyto (melatonin) for the treatment of insomnia in children with autism spectrum disorder and rare neurogenetic disorder Smith-Magenis syndrome, ruling the company had not provided strong enough evidence to show it was cost-effective.

The post Scotland backs Roche’s Rozlytrek for ROS1 lung cancer appeared first on .

Angelman Syndrome Market: Insights Into The Recent Late-Stage Drug Failures And Novel Approaches To Treating This Rare Neurogenetic Disorder

Angelman syndrome (AS) is a complex genetic rare disorder that affects the nervous system. The first sign of a child suffering from Angelman syndrome is a delay in development, such as the inability to sit without support or making incoherent babbling sounds. The hallmarks of the syndrome constitute severe physical disabilities, delayed development, intellectual disability, severe speech impairment, and problems with movement and balance (ataxia). Often affected children experience recurrent seizures (epilepsy) and have a small head size (microcephaly). 

Angelman syndrome is a result of the missing or dysfunctional gene known as UBE3A. The gene is responsible for the normal and healthy development of an individual physically as well intellectually. Usually, only a single copy of the gene is required that too from the mother, however, in cases of AS, either the child does not get any copy, or the child receives two copies – each from mother and father. 

As per Delveinsight’s estimates, the total Angelman syndrome prevalent cases in the 7MM (the US, EU5 (the UK, Germany, Spain, Italy and France) and Japan) was estimated to be 57,716 in 2017. However, many cases go undetected or underdiagnosed since, the diagnosis is usually based on the behavioral phenotype, particularly combinations of movement disorder, absent speech, and happy demeanor. Besides underdiagnosis, a lack of standardized treatment option forms a huge clinical unmet need. The present Angelman syndrome treatment market revolves around the management of symptoms rather than curing the condition. 

However, DelveInsight’s Angelman syndrome market analysis report estimates that several approaches focused primarily on the Gene Therapies, Topoisomerase Inhibitors, Cannabidiol, Protein Phosphatase 2A inhibitor, among others are under development to find a cure for the Angelman syndrome. Several pharmaceutical and biotech companies in the Angelman syndrome market are exploring the novel curative approaches. With high hopes from GeneTx’s therapy after the doors were closed for Ovid, Roche and Sarepta/StrideBio, the AS market is still a risky affair. 

Of all the Angelman syndrome pipeline therapies, the most touted treatment was Gaboxadol (OV101 or THIP), a product of Ovid Therapeutics. The company was running Phase III trials of the therapy for AS; however, the therapy flunked in the trial failing to meet its primary endpoint. As a consequence, Ovid halted everything related to OV101 and Angelman syndrome. The late-stage failure of the therapy has once again tumbled down the hopes and have shown how tough of a nut neurological disorders are to crack. 

Gaboxadol (OV101 or THIP) is an investigational oral therapy that is derived from muscimol, which selectively activates GABAA receptors present on the surface of nerve cells but away from the site where these cells communicate called a synapse. What made it different from the rest of the Angelman pipeline therapies was that it was the first compound targeting disrupted tonic inhibition, and the company hoped that its candidate would be able to restore tonic inhibition. This failure of the Ovid has left the Angelman syndrome market landscape wide open for other pharmaceutical and biotech companies to explore the waters. 

Although, it can be relieving that other players turned to different approaches for finding a cure for Angelman syndrome. For instance, GTX-102, an antisense therapy silencing the gene expression by binding to the RNA molecule behind the regulation of its expression, has also secured USFDA Fast Track Designation. GeneTx and Ultragenyx are co-developing the therapy. In AS patients, the UBE3A gene is only missing in neurons due to its imprinted nature and lack of paternal expression and otherwise morphologically normal. Thus, restoring the presence of this particular gene can help to restore several of the functions of the brain. Preclinical studies undertaken to evaluate the drug have shown that GTX-102 activates the paternal copy of the UBE3A gene in neurons in vitro, and can ease certain disease symptoms in a mouse model of Angelman syndrome. 

However, the journey to secure the FDA nod in the Angelman syndrome market landscape does not seem to be all flowery. The companies had to pause the trials of GTX-102 after the patients temporarily lost the ability to walk. Although the issue was resolved with the full recovery of the affected patients, the drug will be in close scrutiny of agency regulators due to safety concerns. 

PTC Therapeutics is taking homage under AAV vectors to develop its investigational gene therapy GT-AS (initially developed by Agilis Biotherapeutics). GT-AS uses a modified virus, called an adeno-associated virus (AAV) as a carrier to deliver a normal copy of the UBE3A gene to specific central nervous system cells, thereby, maintaining the production of the E6-AP enzyme. The company hopes that this will help to improve cell function and rescue neurological defects, thus will emerge with a cure in the Angelman syndrome therapeutics market. Sarepta Therapeutics and StrideBio collaborated to try their hands in vivo AAV-based therapies for up to eight central nervous system (CNS) and neuromuscular targets. 

With another approach, Biogen is  evaluating ubiquitin-protein ligase E3A (UBE3A) protein levels in cerebrospinal fluid (CSF) in a clinical trial (NCT04103333) under the study “Angelman Syndrome (AS) Biomarker Study.” The primary objective of this study is to measure ubiquitin-protein ligase E3A (UBE3A) protein levels in cerebrospinal fluid (CSF) and to evaluate its utility as a biomarker in support of the development of therapies for AS. 

Further, Roche and Biogen/Ionis are also working on two independent programs in their quest to find a cure in the Angelman syndrome market landscape. Biogen is leading a study, called the AS CSF and Biomarker Study, to find potential biomarkers, biological signs of disease, that can be measured in CSF. These biomarkers could then be used to check if a drug affects AS. Another study, called the AS Endpoint Study, led by Roche, aims to find ways to measure disease impact in the home and clinic and use new technologies to learn about AS. These measurements (endpoints) and technologies focus on areas such as sleep, communication and brain activity. 

Thus, it is essential to wait and watch which theory will manage to touchdown and which will be left in tatters. In the wake of late-stage trial failures, trial pauses, it is yet to see which pharmaceutical or biotech company will manage to emerge as trendsetter salvaging the AS patients.

The post Angelman Syndrome Market: Insights Into The Recent Late-Stage Drug Failures And Novel Approaches To Treating This Rare Neurogenetic Disorder appeared first on DelveInsight Business Research.

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.

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.

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

Shots:

  • The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (1200mg) + Avastin (15 mg/kg) on day 1 of each 21-day cycle vs sorafenib (400mg, bid) on days 1-21 of each 21-day cycle in 501 patients in a ratio (2:1) with unresectable HCC, prior not treated with systemic therapies
  • Results: @median follow-up of 15.6mos., 34% reduction in OS; m-OS (19.2 vs 13.4mos.); mPFS (6.9 vs 4.3mos.). In Chinese population, m-OS (24.0 vs 11.4mos.)
  • Tecentriq + Avastin is an approved therapy across the globe, including in the US, China, Japan and the EU, for people with unresectable HCC and is recommended in many clinical practice guidelines globally

Click here ­to­ read full press release/ article | Ref: Roche | Image: BioSpace

The post Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC first appeared on PharmaShots.

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology.

While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in 2018, it is difficult to get this class of drug distributed through the brain and spinal cord.

But with new technology based on branched silencing RNA licensed from the University of Massachusetts Medical School, Atalanta says it could change this.

Co-founded by Craig Mello, who won the Nobel Prize for Physiology or Medicine in 2006 for his work on RNAi, the company says the technology could be used to treat central nervous system diseases such as Huntington’s, Alzheimer’s and Parkinson’s.

Atalanta has actually been working since 2018 with co-founders Anastasia Khvorova, a UMass biochemist and Neil Aronin, a professor from University of Massachusetts Medical School, providing early leadership.

The company hired Alicia Secor as CEO in summer of 2019, who has previously been CEO of Juniper Pharmaceuticals and serves on the boards of neurology and rare diseases firms GW Pharmaceuticals and Orchard Therapeutics.

Atalanta starts life with two different strategic collaborations with its big pharma backers.

The partnership with Biogen will develop RNAi therapeutics for multiple targets, including HTT for the treatment of Huntington’s disease, as well as additional unnamed CNS targets.

Atalanta will be eligible to receive development and milestone payments as well as undisclosed royalties on any resulting products.

The strategic collaboration with Genentech entails the development of RNAi therapeutics for multiple CNS targets for neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

This could also result in development and milestone payments and royalties.

Unprecedented and astounding

In an interview with pharmaphorum Secor said that the technology comes from a discovery in Khvorova’s lab, which showed the technology allowed potent silencing of Huntington’s for six months in mice.

In 2019 results were published in Nature Biotechnology of the research findings, which were described by Secor as “unprecedented and astounding”.

The founders formed the company with backing from investor F-Prime Capital and has just launched its Series A round with Roche’s Genentech unit and Biogen the first to invest.

Secor said: “In my 30 years I have never seen this level of interest.”

The technology could be used in several indications, according to chief scientific officer and RNAi expert Aimee Jackson.

“There is distribution to multiple regions and deep brain structures and enhanced potency and duration of action,” she said.

With the backing the company already has, Secor said the plan is to focus on preclinical development without needing to worry about funding for the time being.

Quizzed about the possibility of an IPO or buyout from a big pharma company, Secor said the focus is very much on developing the technology.

She told pharmaphorum: “Our long-term vision is to be discovery research and commercialisation platform and product company for a very long time.

“We have a long cash runway to do some building,” she added.

Female leadership

Secor also noted the strong role that women have played in founding and running the company, noting that the name Atalanta refers to the famous female character from Greek mythology.

It also reflects the contribution from Khorova as the founder of the company.

There’s also a connection with Greek mythology from the name of the protein that is targeted by the RNAi drug in Huntington’s – Argonaute 2.

In many versions of Jason’s quest for the Golden Fleece, Atalanta served as the only woman on the crew of the Argo.

Secor noted the recent appointments of Emma Walmsley and Reshma Kewalramani as CEOs at GlaxoSmithKline and Vertex, respectively.

She told pharmaphorum: “I wanted to keep the name to remind us we were named after a woman.

“I think there is a big movement around diversity and inclusion its an opportunity to break through those glass ceilings women should be feeling empowered to take leadership roles.

“It creates a whole lot of opportunities for women. This is a good time for women and I am excited to see more women step into leadership roles.”

 

 

The post RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups appeared first on .

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

Shots:

  • The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged≥12yrs.
  • The approval follows the CHMP’s positive opinion for Xofluza and is based on P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies
  • Xofluza is a first-in-class, single-dose oral therapy, reduces the societal burden of influenza with a rapid reduction in viral replication

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Krauthammer

The post Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza first appeared on PharmaShots.

IL-6 drugs do work in COVID-19, says UK, as it plans NHS use

New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19  patients in intensive care in the UK.

The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) and Kevzara (sarilumab) reduced the relative risk of death by 24% when administered to COVID-19 patients within 24 hours of entering intensive care, and reduce the time spent in hospital by seven to ten days.

Both RoActemra and Kevzara have failed to hit their objectives in earlier studies, leading to speculation that inhibiting IL-6 wasn’t a valid approach to treat severe COVID-19, but the new independent study turns that view on its head.

Crucially, their benefits seem to stack with that of the corticosteroid dexamethasone, the first drug to be shown to improve survival in seriously-ill COVID-19 patients in the RECOVERY trial.

The death rate for those in intensive care units on dexamethasone and respiratory support alone was 35%, but reduced to 28% when RoActemra was administered as well.

“The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives,” said UK deputy chief medical officer Prof Jonathan Van-Tam.

The data has emerged as the government unveiled figures showing there are currently around 30,000 COVID-19 patients in hospitals, up nearly 40% on the previous peak during the first wave of the pandemic in April.

There are already ample supplies of RoActemra in the UK, so that drug in particular will be recommended for use “immediately” in patients admitted to intensive care with the virus, it said, saying that could potentially save “hundreds of lives”.

Roche welcomed the results, saying it was still in the process of analysing data from the COVACTA and EMPACTA trials, which generated negative and positive results for its drug respectively in patients hospitalised with COVID-19 associated pneumonia.

“Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course,” said Professor Anthony Gordon of Imperial College London, the trial’s lead investigator in the UK.

“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment,” he added.

REMAP-CAP has been running since 2016, with the aim of putting dozens of drugs through their paces to see if they can improve the prospects of people with severe community-acquired pneumonia (CAP) caused by influenza, but was expanded to include COVID-19 patients after the pandemic took hold.

It included more than 800 pneumonia patients in intensive care with suspected or proven COVID-19, of which around three-quarters were recruited from UK NHS trusts, but hasn’t yet been subjected to the scrutiny of peer review.

“This news is a positive step in the fight against COVID-19, giving doctors and the NHS another weapon in their armoury to treat critically ill patients,” said Marius Scholtz, chief medical officer at Roche Products Ltd. “It also increases the collective scientific understanding of COVID-19.”

The post IL-6 drugs do work in COVID-19, says UK, as it plans NHS use appeared first on .

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA.

Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint.

The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1.

It’s been granted on the strength of data from the phase 2 CITYSCAPE study – reported at the ASCO congress last year – that showed the pairing shrank tumours in 31% of patients, twice the response seen with Tecentriq (atezolizumab) alone.

First-line immunotherapy for NSCLC is dominated by Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab), transforming the prospects of some patients and propelling the drug to multibillion-dollar sales.

PD-1 or PD-L1 targeting immunotherapy only works in around a third of cases, however, and Roche’s hope is that tiragolumab could boost that proportion and encourage greater use of Tecentriq in first-line NSCLC.

Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

Main rival Keytruda however retains one advantage – a label that include the treatment of patients with low levels of the biomarker – which means that it can be used without chemotherapy in nearly all the first-line NSCLC population.

Ramping up the immune response to cancer with a second checkpoint inhibitor for use alongside the PD-1/PD-L1 inhibitors is on the wish list of many oncologists, although there have already been some big setbacks, such as the demise of Incyte’s IDO1 inhibitor epacadostat in 2018.

Bristol-Myers Squibb’s CLTA4 inhibitor Yervoy (ipilimumab) is already in use for some cancers, including NSCLC in combination with BMS’ PD-1 drug Opdivo (nivolumab), but has been held up by tolerability issues. Meanwhile, drugs targeting TIM-3, LAG3, VISTA and STING also coming through development.

TIGIT is very much among the front runners however, and Roche is being closely pursued by other drug developers including Merck & Co with MK-7684 and Gilead/Arcus, which are also in mid-stage testing, as well as iTeos Therapeutics and Mereo BioPharma.

Another rival – Astellas – fell out of the running last year when it abandoned its phase 1 candidate ASP8374, acquired as part of its $405 million Potenza takeover in 2018.

Roche has already started two phase 3 trials testing the tiragolumab with Tecentriq in lung cancer, and also has half a dozen earlier-stage studies running in other solid tumours as well as blood cancers.

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” said Levi Garraway, Roche’s chief medical officer.

The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on .

Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies.

While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab produces a similar effect but with a 16-week dosing regimen.

Roche’s approach is similar to that taken by Novartis with its ophthalmology drug Beovu (brolucizumab), which can be taken three months apart by some patients in wet age-related macular degeneration, another indication where Eylea is well established.

Roche’s two non-inferiority trials met their main goals, showing that that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks gave similar visual acuity gains compared with Eylea given every eight weeks.

Faricimab was generally well-tolerated, with no new safety signals identified, Roche said.

The studies each have three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase.

In a secondary endpoint, across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one.

This is the first time any investigational medicine has achieved this level of durability in a phase 3 study of people with DME, Roche noted.

Faricimab also has different mechanism of action compared with Eylea and is the first bispecific antibody designed especially for the eye.

It targets two pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME.

Roche is also testing the long-term safety and tolerability of faricimab in DME in the phase 3 Rhone-X study.

Detailed results of YOSEMITE and RHINE will be presented at the Angiogenesis, Exudation and Degeneration 2021 medical conference in Miami next month, and filed with regulators around the world.

The post Roche set to file ophthalmology drug faricimab in DME appeared first on .

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.

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.

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

Shots:

  • The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery)
  • Result of FeDeriCa Study: The GMR for the 1EPs (1.22) with the lower limit (90%) CI of the GMR (1.14≥0.80). 2EPs of non-inferior levels of Herceptin was also met with blood conc. GMR (1.33) with the lower limit (90%)
  • Phesgo combines the same mAb as Perjeta and Herceptin with Halozyme Therapeutics Enhanze drug delivery technology in a novel formulation for SC use

Click here ­to­ read full press release/ article | Ref: Roche  | Image: Fierce Biotech

The post Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer first appeared on PharmaShots.

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer to patients – and also provides a defence against biosimilar competition.

Phesgo combines the anti-HER2 antibodies in Herceptin (trastuzumab) and Perjeta (pertuzumab) in a subcutaneous injection that takes a few minutes to deliver.

At the moment, Herceptin is available as a subcutaneous injection but Perjeta needs to be delivered by intravenous infusion – a process that takes hours – and Roche says that means Phesgo is preferred by both patients and doctors and also reduces the cost of treatment.

Phesgo has been approved by the EU for same indications as Herceptin/Perjeta – in combination with chemotherapy in early HER2-positive breast cancer (pre- and post-surgery) as well as for front-line therapy of HER2-positive breast cancer that has already spread in the body.

The drug was cleared by the FDA in June for the US market and made CHF 7 million (almost $8 million) in preliminary sales in the third quarter, with Roche still in the process of securing formulary approvals.

That’s a drop in the ocean compared to the CHF 1.5 billion and CHF 910 million in Herceptin and Perjeta sales, respectively, in the same period, but with Phesgo Roche is looking to the future.

Herceptin sales dropped a third in the first nine months of the year due in part to the pandemic but mainly the impact of low-cost biosimilars, although Perjeta remains in-patent for the next few years and is growing fast – thanks largely to data from the APHINITY trial which showed that adding it to Herceptin can improve disease-free survival in early-stage breast cancer.

That makes Perjeta a particularly important part of Roche’s product range, particularly as two of its other big-selling antibodies – Avastin (bevacizumab) and Rituxan/MabThera (rituximab) – are also being hit by biosimilar competition.

As many patients with HER2-positive breast cancer received the drug in combination with Perjeta, the convenience of Phesgo is a big draw – patients can be in and out of clinic in 30 minutes rather than three hours or more.

It remains to be seen of course whether payers can be convinced to plump for the new drug over biosimilar trastuzumab plus Perjeta, allowing the drug to mitigate the impact of Herceptin biosimilars on Roche’s HER2 franchise.

“The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives,” said Levi Garraway, Roche’s chief medical officer.

“It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.”

After the US approval, Piper Sandler analyst Joseph Catanzaro said that Phesgo could be an underappreciated blockbuster product that will be a growth driver for Halozyme, the company that provided the drug delivery technology that underpins the new product.

The post Roche claims EU okay for Herceptin/Perjeta combination Phesgo appeared first on .

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

Shots:

  • The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) administered at personalized dosing intervals of ~16wks and at fixed 8wks. intervals & aflibercept (2mg) at fixed 8wks. intervals
  • The studies met its 1EPs i.e faricimab in both the doses demonstrated non-inferior visual acuity gains compared to aflibercept and was well tolerated with no new safety signals identified
  • Faricimab is the first investigational bispecific Ab targeting 2 distinct pathways i.e., Ang-2 and VEGF-A, currently being evaluated in P-III TENAYA and LUCERNE studies for nAMD

Click here ­to­ read full press release/ article | Ref: GlobeNewswire  | Image: Forbes

The post Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema first appeared on PharmaShots.

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.

Insights+: The US FDA New Drug Approvals in November 2020

The US FDA has approved 5 NDAs and 1 BLA in Nov 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 96 novel products so far in 2020, including 6 in Nov 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 6 new drugs approved by the US FDA in Nov 2020.

Sedor’s Sesquient Received the US FDA’s Approval for Status Epilepticus

Published: Nov 09, 2020 | Tags: Sedor Pharmaceuticals, US FDA approval, Sesquient, Treatment, Status Epilepticus, Adult and Pediatric patients

  • The US FDA has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients
  • Sedor is actively in discussions to license the rights to Sesquient for NA, EU, and other territories, except for the People’s Republic of China, where it has already been licensed
  • Sesquient is the first and only FDA-approved room temperature stable fosphenytoin and can help HCPs to treat status epilepticus patients and reduce hospital costs associated with this condition

Eiger’s Zokinvy (lonafarnib) Received the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment Us FDA, Zokinvy

  • The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies
  • Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the FDA has issued an RPD priority review voucher to Eiger
  • Eiger plans to sell the PRV and will share the proceeds equally with PRF, under its supply & collaboration agreement. Zokinvy is a farnesyltransferase inhibitor that has shown a survival benefit in children with Progeria

Alnylam’s Oxlumo (lumasiran) Received the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 23, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, US FDA

  • The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
  • The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
  • In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate

Roche’s Xofluza (baloxavir marboxil) Received the US FDA’s Approval for Post-Exposure Prevention of Influenza

Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected, Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

  • The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
  • Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
  • Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza

Y-mAbs’ Danyelza (naxitamab-gqgk) Received the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA, Y-mAbs Therapeutics

  • The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in the bone marrow
  • The indication is approved under accelerated approval regulation based on ORR and DOR. Continued approval for the indication may be contingent upon verification and description of clinical benefits in a confirmatory trial
  • Danyelza is a mAb that targets the ganglioside GD2 which is highly expressed in various neuroectoderm-derived tumors and sarcomas and has received PR, ODD, BT and RPD from the US FDA

Rhythm’s Imcivree (setmelanotide) Received the US FDA’s Approval for Chronic Weight Management in Patients with Obesity

Published: Nov 27, 2020 | Tags: Rhythm, Pharmaceutical, IMCIVREE, setmelanotide, Receives, US FDA, Approval, Chronic, Weight, Management, Patients, Obesity

  • The US FDA has approved Imcivree for chronic weight management in adult & pediatric patients aged ≥6yrs. with obesity due to POMC, PCSK1 or LEPR deficiency confirmed via genetic testing
  • The approval is based on results of P-III trials that demonstrated 80% of patients with obesity due to POMC or PCSK1 deficiency achieved >10% weight loss & 45.5% of patients with obesity due to LEPR deficiency achieved >10% weight loss after 1yr of treatment
  • The US FDA issued a Rare Pediatric Disease PRV to Rhythm with the approval. The PRV can be redeemed to receive PR for any marketing application or sold/ transferred to other companies for their programs. The therapy is under EMA’s review for approval

Related Post: Insights+: The US FDA New Drug Approvals in October 2020

The post Insights+: The US FDA New Drug Approvals in November 2020 first appeared on PharmaShots.

EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed.

Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious respiratory complications.

This pivotal study is designed to confirm results from the smaller SISCO study that investigated siltuximab plus standard of care in COVID-19 patients with serious respiratory complications.

Primary outcome of the SILVAR study will be all-cause 28-day mortality.

Siltuximab is an IL-6 inhibiting drug that was originally developed and marketed by the Johnson & Johnson’s Janssen unit for the rare disorder idiopathic multicentric Castleman’s disease.

EUSA Pharma bought global rights to the drug from Janssen in $115 million.

Roche and Sanofi/Regeneron have already tried to alleviate symptoms with their respective IL-6 drugs, Actemra (tocilizumab) and Kevzara (sarilumab), but trials did not produce supportive results.

EUSA said that unlike previous studies of agents targeting the IL-6 signalling pathway, the SILVAR study has been rationally designed to select those hospitalised patients still suffering from serious viral acute respiratory distress syndrome (ARDS).

Patients selected will be in a hyperinflammatory state that will most likely benefit from the addition of an immunomodulator, such as siltuximab.

Respiratory failure from ARDS is the leading cause of mortality in patients with COVID-19.

Siltuximab binds to and neutralises IL-6, a chemical signal in the body that is recognised as a key driver of ARDS in COVID-19 and other respiratory infections.

The SISCO trial earlier this year in COVID-19 compared 30 patients treated with siltuximab with 30 matched controls, and showed that treatment with the drug led to a 54% reduction in risk of 30-day all-cause mortality.

EUSA Pharma’s CEO Lee Morley said: “This clinical trial represents an important step in finding a solution for hospitalised patients with serious respiratory complications due to an over reactive immune response to (coronavirus) infection that is not fully responsive to corticosteroid therapy, as well as those with any other respiratory virus infection associated with serious ARDS.”

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed appeared first on .

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Handelsblatt

The post Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer first appeared on PharmaShots.

Digital Diabetes Market to Reach $1.5B by 2024, Research Finds

Diabetes Management Apps Global Mobile Health Solutions_7 Best Practices for Developing Successful Diabetes Mobile Apps

What You Should Know:

– The digital diabetes market is on track to reach $1.5
billion dollars by 2024, according to a new report by Research2Guidance.

– The confident growth of digital diabetes care will be driven by the growth of the global addressable market for digital diabetes services. Between 2019 and 2024, the number of diagnosed diabetics with access to smart devices is set to increase from 109 million to 180 million. 

– Digital diabetes solutions have disrupted the diabetes
care market and are changing overall chronic care, targeting not only diabetes
but also its various comorbidities, such as obesity, hypertension, and
depression.

– The report, The
Global Digital Diabetes Care Market 2020: Going Beyond Diabetes Management focuses
on the continued expansion of
digital diabetes providers into other chronic conditions (vertical expansion)
and new service opportunities (horizontal expansion), highlighting the market’s
strategic direction in the next few years. This expansion will create new
revenue opportunities, improve payer acceptance, and grow user bases beyond the
diagnosed diabetes audience.

– In the report, the Top 10 market players LifeScan Inc., Ascensia Diabetes Care, Informed Data Systems (One Drop), mySugr (Roche), H2 Inc., Livongo Health, Omada Health, Abbott, Dexcom, and Dario Health are profiled with their offerings, mobile app portfolio performance, and strategy analysis, as well as Top 10 country profiles (market opportunity size, number of solutions, downloads, number of users, Top 5 players).

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.

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots:

  • Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19
  • Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the US
  • The combination regimen is being studied globally in a P-II/III study for patients with COVID-19 who require hospitalization, in P-II/III clinical study for non-hospitalized patients with COVID-19, and P-III clinical study for prevention of infection in COVID-19 household contacts

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Wikipedia

The post Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan first appeared on PharmaShots.

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Shots:

  • Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, Roche has also filed a EUA to the US FDA
  • The test showed 94.5% sensitivity across 200 PCR confirmed symptomatic individuals & 99.9% specificity across 2747 PCR negative symptomatic & screening individuals in clinical studies. The company plans to ramp up production to have a double-digit million number of tests/ month, in early 2021
  • The test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx & oropharynx. The test is the latest addition to Roche’s COVID-19 portfolio

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Business Standard

The post Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing first appeared on PharmaShots.

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Shots:

  • Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with MIUC, who are at high risk of recurrence following resection
  • Results: in people with ctDNA, DFS Median (5.9 vs 4.4 mos.); median OS (25.8 vs 15.8 mos.). As presented in ASCO, the study did not meet its 1EPs of DFS (19.4 vs 16.6 mos.) in IIT population
  • In general, people with MIUC who had detectable ctDNA were more likely to benefit from treatment with adjuvant Tecentriq monothx. compared with those without ctDNA

Click here ­to­ read full press release/ article | Ref: Roche | Image: Mint

The post Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020 first appeared on PharmaShots.

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots:

  • Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs
  • The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine is in late-stage trials with 30,000+ participants, showed the efficacy of 94% in preventing COVID-19, and is designed to trigger an Ab response to proteins found on the coronavirus spike’s receptor-binding domain
  • Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of Abs (including IgG) to SARS-CoV-2

Click here to­ read full press release/ article | Ref: Roche | Image: The Conversation

The post Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials first appeared on PharmaShots.

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Shots:

  • Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs
  • The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine is in late-stage trials with 30,000+ participants, showed the efficacy of 94% in preventing COVID-19, and is designed to trigger an Ab response to proteins found on the coronavirus spike’s receptor-binding domain
  • Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of Abs (including IgG) to SARS-CoV-2

Click here to­ read full press release/ article | Ref: Roche | Image: The Conversation

The post Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials first appeared on PharmaShots.

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Shots:

  • The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple types of blood cancer
  • Roche divulges that its mosunetuzumab & glofitamab showed promising responses across multiple types of NHL, including R/R FL & DLBCL, reinforcing from the P-I/Ib GO29781 study results in R/R FL, that showed 51.6% of patients achieved a CR when treated with mosunetuzumab
  • Beyond r/r setting, mosunetuzumab & glofitamab are also being evaluated in 1L DLBCL. Additionally, Roche has presented the data of cevostamab that showed a 53% ORR rate in heavily pre-treated patients with MM

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Financial Times

The post Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020 first appeared on PharmaShots.

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Shots:

  • The P-lb/ll GO29365 study involves assessing of Polivy (polatuzumab vedotin) + BR vs BR as monthx. in 106 patients with r/r DLBCL who are not eligible for stem cell transplant
  • Result: @48.9mos. CR rate (42.5% vs 17.5%); m-PFS (9.2 vs 3.7 mos.); m-OS (12.4 vs 4.7 mos.); New data from the extension cohort, in 37 patients with 2L DLBCL showed Polivy + BR is effective across a broad range of patients and showed m-PFS (6.6 mos.); median OS (12.5 mos.)
  • Sub-group analyses showed that combination was effective in different patient populations with the results from the pooled Polivy + BR arms achieving an m-OS of 7.6mos. in primary refractory patients and 32.0mos. in non-primary refractory patients

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Reuters

The post Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma first appeared on PharmaShots.

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Cladding Corp

The post Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020 first appeared on PharmaShots.

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Shots:

  • Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL
  • The data showed a reduction in the risk of disease progression or death by 81%, m-OS (82.1% vs 62.2%), patients who completed 2yrs. of treatment without the progressive disease, 63.8% had uMRD
  • The P-III CLL14 study also confirms the potential of MRD measurements to predict future outcomes for people with prior untreated CLL who were treated with fixed-duration Venclexta/Venclyxto + Gazyva/Gazyvaro vs Gazyva/Gazyvaro + chlorambucil

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fierce Pharma

The post Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

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

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

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

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

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

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

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

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

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

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

TG Therapeutics challenges Roche with FDA filing for CLL drug

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche.

The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon.

The FDA had already granted fast-track designation to the combination therapy, allowing extra help during the development process on the basis of earlier clinical data.

Aside from Gazyvaro, CLL can be treated with older chemotherapy agents, or Roche/AbbVie’s Venclexta (venetoclax) in some instances, and the fast track tag showed the FDA considered the combination to be a promising new contender on the market.

TG said it expects the data submission to be complete in the first half of 2021.

The rolling filing is designed to speed up the review process for results from the UNITY-CLL trial, a phase 3 study comparing the combination therapy also known as U2, with an active control arm of Roche’s Gazyvaro (ofatumumab) plus chlorambucil.

The trial randomised patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib, and an active control arm of obinutuzumab plus chlorambucil.

A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms.

The trial continued enrolment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.

Around 420 people were recruited to the two combination arms and around 60% were untreated and 40% were relapsed or refractory.

Primary endpoint was superior progression-free survival in the control arm and topline results were announced in May, showing a statistically significant improvement in PFS in the combination therapy arm.

The company had hoped to file data from an interim analysis of the trial in late 2018, but suffered a setback when an independent assessment board said the data was not mature enough for an analysis of the overall response rate.

The FDA is also due to make a decision next year on umbralisib as a single agent for marginal zone lymphoma and follicular lymphoma.

The post TG Therapeutics challenges Roche with FDA filing for CLL drug appeared first on .

Roche, Blueprint raise pressure on Lilly with new Gavreto approval

The FDA has cleared Roche and Blueprint Medicine’s Gavreto for a new use in RET-mutated thyroid cancer, putting it on a level playing field with Eli Lilly’s rival therapy Retevmo.

The US regulator says Gavreto (pralsetinib) can be used to treat patient aged over 12 with advanced or metastatic RET-mutant thyroid tumours, adding to its earlier approval for adults with metastatic RET-positive non-small-cell lung cancer (NSCLC) in September

Retevmo (selpercatinib) was simultaneously approved by the agency for the lung and thyroid cancer in May, so has enjoyed an all-too brief period as the first and only drug for both RET-driven tumour types in the US – particularly as Gavreto’s latest green light has come three months ahead of schedule.

Retevmo is still in the early stages of rollout, adding a little under $12 million to Lilly’s top-line in the third quarter of this year, and will now have to contend with a rival drug backed by Roche’s considerable oncology marketing clout.

Roche clearly has high expectations for Gavreto, agreeing a licensing deal with Blueprint in June that could be worth up to $1.7 billion if it hits development and commercial targets. A hefty $675 million of that was in upfront cash, with another $100 million in equity.

Gavreto’s label says it can be used for patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or patients with RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

The latest Gavreto approval was based on results from the Phase 1/2 ARROW trial evaluating Gavreto in RET-altered cancers, including thyroid cancer, NSCLC and other solid tumours.

It had a 60% overall response rate in patients previously treated with Exelixis’ Cometriq (cabozantinib) or Sanofi’s Caprelsa (vandetanib), both kinase inhibitors that combine activity against RET with other targets.

The drug was also tested in patients with RET-mutant MTC who did not receive prior Cometriq or Caprelsa, with shrinking tumours in 64% of them, 84% of whom had responses that lasted six months or more. Among patients with RET fusion-positive thyroid cancer who were radioactive iodine-refractory, the ORR was 89%, all lasting at least six months.

The data – which is fairly closely matched with Lilly’s results with Retevmo (with the usual caveats about comparing different trials) – is also being evaluated by the EMA in Europe with a decision expected next year.

Both drugs are in pill form, with Gavreto given once daily while Retevmo is taken in two separate doses, and there are trade-offs when it comes to tolerability, according to some analysts.

Both drugs are linked to side effects including high blood pressure, liver toxicity and haemorrhage, but Retevmo’s label also includes a warning about cardiac effects (QT interval), and Gavreto’s mentions interstitial lung disease/pneumonitis.

Prostate cancer imaging agent also gets the nod

The FDA has also just approved Gallium 68 PSMA-11, the first PET imaging agent for prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Developed by the University of California, Los Angeles (UCLA) and the University of California, San Francisco (UCSF) – which hold the marketing license – the imaging agent is approved to identify if prostate cancer has spread to other parts of the body.

If identified, those metastases are potentially curable using surgery or radiotherapy, according to the FDA. At the moment metastases can be spotted with MRI or CT scanning but are not very effective at finding prostate cancer spread.

Two other PET drugs – F 18 fluciclovine and C 11 choline – are approved for prostate cancer imaging. However, they are only approved for use in patients with suspected cancer recurrence.

The post Roche, Blueprint raise pressure on Lilly with new Gavreto approval appeared first on .

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche.

The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them.

Roche, which decided the products were surplus to requirements in an already-packed pipeline, also received a shareholding in Noema, in exchange for rights to the four clinical-stage product-candidates.

Lead product is NOE-101, an mGluR5 inhibitor that is ready for phase 2b trials in two indications – for persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia.

The company is also preparing NOE-15, a PDE10A inhibitor for phase 2b testing to treat Tourette Syndrome.

It also has two other clinical stage assets – mGluR2/3 inhibitor NOE-109 and NOE-115, a triple reuptake inhibitor that are being evaluated in undisclosed indications.

The latest financing round was co-led by Sofinnova Partners, a European life sciences venture capital firm based in Paris, London and Milan, and Polaris Partners, a healthcare and technology investment firm based in the US.

The global consortium of new international investors includes Gilde Healthcare, Invus and BioMed Partners.

Noema was founded last year with a seed investment from Sofinnova partners and is led by CEO Luigi Costa, former CEO of haematology and oncology firm Nordic Nanovector.

He was also a senior figure at Onyx Pharmaceuticals, which was acquired by Amgen in 2014 and led the company’s international organisation and the launch of multiple myeloma drug Kyprolis outside the US.

The company also has the expertise of George Garibaldi as chief medical officer, a former Roche vice-president.

Costa said: “The successful licensing of these exciting clinical-stage product-candidates from Roche, together with our up-sized CHF54 million Series A financing, will enable Noema to reach value-creating development milestones with all four products.”

The post Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche appeared first on .

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA’s, Y-mAbs Therapeutics

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected,  Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

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

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment, Us FDA, Zokinvy

Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

Related Post: PharmaShots Weekly Snapshot (Nov 16-20, 2020)

The post PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) first appeared on PharmaShots.

FDA approves Roche’s Xofluza to prevent flu spreading in families

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person.

Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.

With this third indication, Xofluza has become the first single-dose medicine approved for this new use also known as post-exposure prophylaxis.

This provides a more convenient alternative to older drugs such as Roche’s own Tamiflu (oseltamivir), which is taken once daily for 10 days in this indication.

Approval was based on the phase 3 BLOCKSTONE study, recently published in the New England Journal of Medicines, which compared Xofluxa with placebo as a preventive treatment for household members who were living with someone with flu.

Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact.

The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified.

The most frequently reported adverse events occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza included diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

It’s hoped that the new indication could take the pressure of health systems that are struggling to cope with the extra workload caused by the COVID-19 pandemic.

Serese Marotta, chief operating officer at Families Fighting Flu, said: “The flu is a serious illness that burdens households and sickens millions across the U.S. every year.

“As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”

Genentech is in talks with the FDA to develop Xofluza for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.

The post FDA approves Roche’s Xofluza to prevent flu spreading in families appeared first on .

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
  • Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
  • Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: BioSpace

The post Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, Develop, Manufacture, Mesoblast, Novartis, Remestemcel-L, Signs, Treatment

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Published: Nov 20,2020 | Tags: (adalimumab), Alvotech, AVT-301 Study, AVT-GL-101, AVT02, Chronic Plaque Psoriasis, EMA, Humira, Proposed Biosimilar, Regulatory Applications, Submits, Us FDA

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin Delivery System for People with Diabetes

Published: Nov 20, 2020 | Tags: Lilly, Signs, Agreement, Ypsomed, Advance, Automated Insulin Delivery System, People, Diabetes

Pfizer And LianBio Collaborate to Expand the Development of Novel Therapeutics in Greater China

Published: Nov 20, 2020 | Tags: Pfizer, LianBio, Collaborate, Expand, Development, Novel Therapeutics, Greater China

AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

Published: Nov 20,2020 | Tags: AstraZenca, CASPIAN Study, durvalumab, Imfinzi, P-lll, PACIFIC, US FDA’s

Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Published: Nov 19, 2020 | Tags: approval, Bronchitol, Chiesi, Cystic Fibrosis, Inhalation, Mannitol, Powder, Pulmonary, receives, US FDA

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

Published: Nov 19, 2020 | Tags: Authorization, COVID-19, First, Home, Lucira, Lucira Health, Molecular, Prescription, receives, Test, Us FDA

Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

Published: Nov 19, 2020 | Tags: Bayer, Collaborate, Developed, G4A Digital Health, Healthcare Solutions, Integrated

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Published: Nov 19, 2020 | Tags: Progress, reports, results, study, ViiV Healthcare

Pear Therapeutics Launches Somryst Insomnia App Via an End-to-End Virtual Care Experience

Published: Nov 19, 2020 | Tags: Chronic Insomnia, Launches, Pear Therapeutics, Somryst

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Published: Nov 19, 2020 | Tags: 95%, BioNTech, BNT162b2, COVID-19, Demonstrates, Efficacy, Pfizer, Preventing

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Published: Nov 19, 2020 | Tags: EC’s, Influenza, Marketing Authorization, patients, quadrivalent recombinant influenza vaccine, receives, Sanofi, Supemtek

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Published: Nov 18,2020 | Tags: Acceptance, Biogen, Biosimilar, FDA Filing, Lucentis, ranibizumab, Retinal Vascular Disorders, Samsung Bioepis, SB11

BioMarin Pharmaceutical Signs an Agreement with Deep Genomics on Advancing Programs Identified Using Artificial Intelligence

Published: Nov 18, 2020 | Tags: Advancing, Agreement, Artificial Intelligence, BioMarin Pharmaceutical, Deep Genomics, Identified, Programs, Signs, Using

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

Published: Nov 18, 2020 | Tags: 4, COVID-19, Delivery, Deployment, Immunization, Pfizer, Pilot, Program, states, Updates, US,

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Published: Nov 18, 2020 | Tags: Avalglucosidase-alfa, BLA, Enzyme Replacement Therapy, Pompe disease, Priority Review, receives, Sanofi, US, FDA

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Published: Nov 18,2020 | Tags: Breakthrough, Cabotegravir, Designation, HIV, receives, therapy, Us FDA, ViiV Healthcare

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published: Nov 18,2020 | Tags: BAY 94-8862, Bayer, Cardiovascular Disease, Chronic Kidney Disease, FIDELIO-DKD Study, Finerenone, Inflammatory, Type 2 Diabetes

QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Published: Nov 17, 2020 | Tags: (tigilanol tiglate injection), Non-Metastatic Mast Cell Tumors, QBiotics Group, receives, Stelfonta, US FDA’s Approval

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Published: Nov 17, 2020 | Tags: COVID-19, ENSEMBLE, ENSEMBLE-2 Study, Initiates, Johnson & Johnson, P-lll

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Published: Nov 17,2020 | Tags: Develop, Immune Mediated Diseases, Lead Pharma, License Agreement, Research Collaboration, Roche, Signs, Small Oral Molecules

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Published: Nov 17,2020 | Tags: Advanced, ALX Oncology, ALX148, Breast Cancer, Collaborate, Evaluate, HER2‑Expressing, Zanidatamab, Zymeworks

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Published: Nov 17, 2020 | Tags: COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Published: Nov 17,2020 | Tags: Against, Bharat Biotech, Covaxin, COVID-19, Initiates, P-III, study

Microsoft Collaborates with Twist and Illumina to Advance Data Storage in DNA

Published: Nov 16, 2020 | Tags: advance, Collaborates, Data Storage, DNA, Illumina, Microsoft, Twist

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Published: Nov 16, 2020 | Tags: Agreement, Candidate, Covid-19 Vaccine, Development, Expand, J&J, U.S. Department of Health & Human Services

Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Published: Nov 16, 2020 | Tags: Eisai’s, EU’s Approval, Fycompa, perampanel, PGTCS, POS, receives

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Published: Nov 16, 2020 | Tags: baloxavir marboxil, EU’s Approval, Influenza, receives, Roche, Xofluza

Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies

Published: Nov 16, 2020 | Tags: Eli Lilly, License Agreement, Protein Degradation-Based Therapies, Seed Therapeutics, Signs

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020 | Tags: (biosimilar, Acceptance, daratumumab, Henlius, HLX15, Multiple Myeloma, NMPA, Report, Treat

Related Post: PharmaShots Weekly Snapshots (Nov 09-13, 2020)

The post PharmaShots Weekly Snapshot (Nov 16-20, 2020) first appeared on PharmaShots.

Lead Pharma signs $308m deal to develop small molecule drugs with Roche

Lead Pharma has signed a potential 260 million euro ($308 million) deal with Roche to develop small molecule drugs for immune diseases.

The deal will revolve around a single undisclosed drug target and will see the Dutch biotech receive 10 million euros up front from Roche.

Lead will lead the selection of a pre-clinical drug candidate, after which Roche will be responsible for further development and global marketing.

Based in Oss-Netherlands, Lead will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to 260 million euros, plus royalties on worldwide sales.

The biotech’s chief scientific officer Arthur Oubrie said: “Our rigorous target selection process, translational screening cascade, and smart medicinal chemistry have been essential to bring this project to this stage. We are keen to collaborate with our colleagues at Roche to bring this novel approach to patients.”

The company has been working with Sanofi since 2015 on a small molecule targeting ROR gamma, a regulator of T-helper 17 immune cells.

It has already received four milestone payments under this first agreement, which targets autoimmune disorders including common diseases such as psoriasis, rheumatoid arthritis and  inflammatory bowel disease.

In March last year Sanofi began a phase 1 clinical trial of the treatment , triggering the most recent payment.

Roche is clearly looking to expand from the cancer beat where it has made most of its money in the last few decades.

Sales of its “big three” cancer drugs Avastin, Herceptin and Rituxan are slipping away because of competition from cheaper biosimilars.

It has had limited success with newer oncology drugs, which have not produced the annual sales of more than $20 billion generated by these drugs at their peak.

Roche last year signed a $792.5 million deal with immune-mediated disease focused Rheos Medicines, based in Cambridge, Massachusetts.

The US biotech got $42.5 million up front, with a further $90 million due in research and pre-clinical development milestones.

The remainder will come from development, regulatory and sales milestones, plus tiered royalties.

The post Lead Pharma signs $308m deal to develop small molecule drugs with Roche appeared first on .

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Shots:

  • Lead Pharma receives ~$11.86M upfront and is eligible to receive funding and ~$307.9 as research, development, regulatory and commercial milestones along with royalties on sales of small molecules
  • The companies will collaborate in research activities up to the selection of a pre-clinical candidate after which Roche will be responsible for the development and global commercialization
  • The R&D collaboration builds on Lead Pharma’s expertise in the discovery, design, and optimization of small-molecule treatments

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

The post Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases first appeared on PharmaShots.

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Shots:

  • The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs.
  • The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies. The company is expecting the EC’s final decision in approval in the near future
  • Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein and is available in the US and in several other countries for influenza types A and B

Click here ­to­ read full press release/ article | Ref: Roche | Image: Tele trader

The post Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza first appeared on PharmaShots.

Roche’s Herceptin/Perjeta combo product nears EU approval

The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s defense against Herceptin biosimilars.

Called Phesgo, the new product contains the active substances in Herceptin (trastuzumab) – already facing lower-cost competition in the US and Europe – and Perjeta (pertuzumab), which are both used to treat HER2-positive breast cancers.

Phesgo comes in a single-dose vial and can be dosed as a subcutaneous injection, while at the moment breast cancer patients the two anti-HER2 drugs separately receive Herceptin as a subcutaneous injection and Perjeta as an intravenous infusion, says the CHMP.

According to the committee, the combination offers “less invasive and faster administration as a single product” to patients. After a first eight-minute loading dose, each treatment takes about five minutes to administer and can be carried out at home.

In contrast, Herceptin/Perjeta administration needs to be done in a clinic and takes more than two hours for the first dose and an hour thereafter. Aside from the convenience, avoiding the need to go into a treatment centre is desirable during the coronavirus pandemic, according to Roche.

Phesgo has been recommended by the CHMP for use in combination with chemotherapy in early HER2-positive breast cancer – pre- and post-surgery – as well as for front-line therapy of HER2-positive breast cancer that has already spread in the body.

A CHMP recommendation is usually followed by EMA approval within a few weeks. Phesgo is already available in the US, having been approved by the FDA in the summer.

Perjeta has become one of Roche’s fastest-growing and top-selling drugs, thanks in no small part to data from the APHINITY trial which showed that adding it to Herceptin can improve disease-free survival in early-stage breast cancer.

Despite the impact of the pandemic on cancer care, Perjeta grew 17% to CHF 2.9 billion ($3.2 billion) in the first nine months of 2020, now just fractionally behind Herceptin which declined 31% to CHF 3.1 billion in the same period as biosimilars ate into its market share.

That makes Perjeta a particularly important component in Roche’s product range, particularly as two other big-selling antibodies – Avastin (bevacizumab) and Rituxan/MabThera (rituximab) – are also being hit by biosimilar competition.

Rolling out a subcutaneous formulation has already allowed Roche to mitigate the impact of copycat versions of Herceptin and Rituxan, and it is hoping it can repeat the trick with Phesgo, as Perjeta’s patents start to expire within the next four years.

It’s too early to say if that strategy will be successful. Roche revealed in its third quarter results statement that initial US sales of Phesgo were CHF 7 million, with the company still working on gaining formulary approvals in the US.

Xofluza also recommended

Roche also claimed a CHMP recommendation for Xofluza (baloxavir marboxil), a one-dose oral therapy for influenza that is a successor the company’s former blockbuster Tamiflu (oseltamivir), which has also lost patent protection.

Xofluza has been given a positive opinion by the CHMP as a treatment for uncomplicated influenza in people aged 12 and over, and to prevent infection in people exposed to someone with flu. The drug was approved by the US FDA last year.

The post Roche’s Herceptin/Perjeta combo product nears EU approval appeared first on .

NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug

Previously-untreated patients with hepatocellular carcinoma (HCC), a common form of liver cancer, will have an immunotherapy-based treatment option after NICE gave the nod to NHS funding of Roche’s Tecentriq and Avastin combination therapy.

The decision by NICE comes shortly after Tecentriq (atezolizumab) and Avastin (bevacizumab) was approved by the European Commission as a first-line treatment for adults with advanced or inoperable HCC, becoming the first and only immunotherapy regimen approved in Europe for this patient group.

Approval was based on findings of the phase 3 IMbrave 150 study, which showed an improvement in overall survival compared with Bayer’s Nexavar (sorafenib), one of the standard treatments for previously-untreated liver cancer along with Eisai’s Lenvima (lenvatinib).

NICE’s final appraisal document notes that patients receiving the dual regimen “live longer and have longer before their disease progresses than people who have sorafenib” and it is a cost-effective use of NHS resources.

It is the first treatment to be approved in Europe for over a decade that has improved overall survival for people with previously untreated advanced or unresectable HCC.

HCC accounts for 90% of all liver cancer cases and there are around 5,900 new cases in the UK every year. The disease is also becoming more common – Roche says the incidence of HCC is projected to rise by 38% to 15 cases per 100,000 people by 2035.

“Tecentriq, in combination with Avastin, is the only cancer immunotherapy treatment, approved by NICE for this indication,” said Gemma Boni, head of liver cancer at Roche Products Ltd.

“We hope that it can help further improve overall survival rates, while having a generally manageable safety profile, compared to what is already achieved,” she added.

The Tecentriq/Avastin combination is crucial to Roche’s immuno-oncology franchise, and along with HCC has also been approved to treat non-squamous non-small cell lung cancer (NSCLC).

Sales of Tecentriq sales rose 64% to around $2.2 billion in the first nine months of this year, but Avastin has started to succumb to biosimilar competition, shrinking 22% to a little over $4 billion in the same period.

Cablivi gets green light for aTTP

NICE’s recommendation that Sanofi’s Cablivi (caplacizumab) can be covered by the NHS, is also a big step forward for patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder that can be fatal without prompt treatment.

Cablivi is the first treatment specifically approved for aTTP in 30 years, and the only therapy approved for people experiencing an acute aTTP episode. NICE has backed the drug after rejecting it earlier this year due to an “improved commercial arrangement” with Sanofi – in other words a price discount.

Cablivi was also recommended for NHS use by the Scottish Medicines Consortium (SMC) in September.

aTTP is a rare disease where blood clots form in small blood vessels throughout the body, limiting the flow of oxygen to organs, such as the brain, kidney and heart. NICE’s appraisal document says that Cablivi, combined with plasma exchange and immunosuppression, reduces time to bring blood platelet levels back to normal.

Sanofi welcomed the positive recommendation, but said access to Cablivi had been delayed by procedural issues at NICE.

As a treatment for an ultra-rare disease, Cablivi was initially supposed to be considered within the Highly Specialised Technology (HST) process, but was assessed under the Single Technology Appraisal (STA) process.

The STA does not consider the concerns around long-term follow-up and management, which are a well-known issue in evaluating medicines for ultra-rare diseases, says the company, which claims this delayed access to the drug.

“We now hope that the forthcoming NICE Methods Review and Innovative Drugs Fund consultation will fix the ongoing barriers for patients,” commented Deborah Lough, head of rare blood disorders UK & Ireland at Sanofi Genzyme.

NICE estimates that more than 100 people each year will be eligible for treatment with Cablivi.

Image by PublicDomainPictures from Pixabay

The post NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug appeared first on .

NICE backs chemo-free CLL combination from AbbVie and Roche

Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of AbbVie’s Venclyxto and Roche’s Gazyva.

The decision by NICE allows for the 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial.

This showed the combination of Venclyxto (venetoclax) and Gazyva (obinutuzumab) had superior progression-free survival and sustained that benefit after stopping treatment compared with those receiving a commonly used chemoimmunotherapy regimen of Gazyva and chlorambucil chemo.

NICE recommended the combination in patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable.

The cost-effectiveness body also recommended the combination for use within the Cancer Drugs Fund (CDF) for patients without del(17p)/TP53 mutation and for whom FCR or BR are suitable, subject to a managed access agreement.

The combination therapy will be available to NHS patients in England immediately.

CLL is the most common type of chronic blood cancer, with around 10 new patients diagnosed every day.

Unlike some cancers, CLL has a highly variable clinical course so patients are usually left to ‘watch and wait’, after which some patients will be offered appropriate treatment.

However, despite novel therapeutic advancements in CLL, the disease remains incurable and patients will often relapse following treatment.

Professor Peter Hillmen, consultant in clinical haematology at Leeds Teaching Hospitals and honorary professor of haematology at University of Leeds, said that the treatment can produce a “deep response.”

“Ultimately, this has the potential to improve patients’ quality of life and reduce the significant burden of therapy,” he added.

The European Commission approved the combination therapy for the treatment of for adult patients with previously untreated chronic lymphocytic leukaemia in March 2020.

Venetoclax is being developed by AbbVie and Roche. It is jointly marketed by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.

The post NICE backs chemo-free CLL combination from AbbVie and Roche appeared first on .

Sanofi/Alnylan’s haemophilia drug hits another safety speed-bump

Sanofi’s attempt to take on Roche with a ground-breaking approach to treating haemophilia has hit a setback after the company voluntarily placed its late-stage trials of fitusiran on hold because of safety issues.

The news that phase 3 development has been put on hold was not announced by the French pharma, but in a joint statement from three haemophilia patient groups.

Sanofi’s management has highlighted fitusiran, a potential competitor to Roche’s haemophilia A drug Hemlibra, as one of the most important drugs in its pipeline.

Fitusiran is being developed for haemophilia A and B in partnership with RNA interference (RNAi) specialist Alnylam – but has already been affected by safety issues.

Alnylam temporarily halted a phase 2 trial in 2017 after a blood clot killed a patient but research resumed in late 2017 after the FDA and Alnylam agreed on new clinical risk mitigation measures.

In a joint statement the World Federation of Hemophilia, the European Haemophilia Consortium and the National Hemophilia Foundation said Sanofi had voluntary put the full development programme on hold “due to the identification of new adverse events”.

In a research note a team of analysts from Jefferies said that fitusiran is unlikely to make difference to Sanofi’s bottom line but could be a “key catalyst to invigorate belief” in the company’s drug pipeline.

According to Jefferies the trial was put on hold to allow investigations of “non-fatal thrombotic events” on 30 October.

Jefferies said it remains unknown if these events are treatment-related or reflect existing illnesses in patients.

The safety events were perhaps compounded by COVID19, which has been associated with abnormal blood clotting in some serious cases.

In the note the Jefferies team led by Peter Welford said that “a setback would likely be perceived negatively for sentiment, particularly as belief in the pipeline is beginning to be built.”

This is likely a reference to Sanofi’s success with Dupixent (dupilumab), developed in partnership with Regeneron for disease including asthma and eczema, which has helped revive the company’s fortunes since a first approval in 2017.

Alnylam’s RNAi technology uses small interfering RNA molecules to target strings of defective RNA molecules in cells, preventing them from coding disease-coding proteins.

 

 

 

 

The post Sanofi/Alnylan’s haemophilia drug hits another safety speed-bump appeared first on .

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

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

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

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

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

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

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

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

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

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

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

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

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

The post PharmaShots Weekly Snapshot (Nov 02-06, 2020) first appeared on PharmaShots.

Europe approves Roche’s Tecentriq liver cancer combination

The European Commission has approved Roche’s Tecentriq immunotherapy, in combination with its established cancer drug Avastin, for patients with the most common form of liver cancer.

Tecentriq (atezolizumab) can be used with Avastin (bevacizumab) for adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received systemic therapy.

Approval is based on findings of the phase 3 IMbrave 150 study, which showed an improvement in overall survival compared with Bayer’s Nexavar (sorafenib), which has long been the standard of care in liver cancer.

The study showed that Tecentriq in combination with Avastin reduced risk of death by 42% and reduced risk of disease worsening or death by 41% compared with Nexavar.

This result was the first time that a phase 3 cancer immunotherapy showed an improvement over Nexavar in both overall survival and progression-free survival.

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib.

The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

The decision follows approval of the combination therapy from the FDA in May, and from China’s National Medical Products Administration last month, although the latter decision only applied to untreated patients with unresectable disease.

Tecentriq is becoming increasingly important to Roche as sales of its “big three” cancer drugs Avastin, Herceptin, and Rituxan/MabThera fall away because of competition from cheaper biosimilars.

Sales of Tecentriq were up 64% in the first nine months of this year to just over 2 billion swiss francs ($2.2 billion), making it one of the company’s fastest growing products, and the fastest growing excluding recently launched products.

A PD-L1 class checkpoint inhibitor, Tecentriq works by calling in an attack from the patient’s immune system and since hitting the market in 2016 has already picked up US approvals in a range of oncology indications including lung and bladder cancer.

The big Swiss pharma is also developing it for several other types of lung, genitourinary, skin, breast, gynaecological and head and neck cancers.

The post Europe approves Roche’s Tecentriq liver cancer combination appeared first on .

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: Roche | Image: Business Recorder

The post Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma first appeared on PharmaShots.

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.

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

Published: Oct 22, 2020 | Tags: 2020, ASN Calcification, Kidney, reports, results, Sanifit, SNF472, Treatment, Vascular, Week

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

Published: Oct 22,2020 | Tags: Activated, Daiichi, DS-1055, GARP, Immuno, Initiates, Oncology, P-I, Regulatory, T Cells, Targeting, therapy, Trial

UCB’s Vimpat (lacosamide) Receives CHMP’s Positive Opinion for Primary Generalized Tonic-Clonic Seizures

Published: Oct 22,2020 | Tags: CHMP’s Positive Opinion, EU Approval, lacosamide, Primary Generalised Tonic-Clonic Seizure, receives, UCB’s, Vimpat

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

Published: Oct 22,2020 | Tags: ASN Week 2020, Dicerna, Evaluating, Nedosiran, New Interim Data, PHYOX 3 OLE, Presents, Primary Hyperoxaluria, study

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 22,2020 | Tags: COVID-19, Gilead, receives, Remdesivir, US FDA Approval, Veklury

ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

Published: Oct 21, 2020 | Tags: Antiretroviral Therapy, ATLAS, ATLAS-2M, Cabenuva, Cabotegravir, COVID-19, CUSTOMIZE, FLAIR, LATTE-2, P-IIb/IIIb, POLAR, reports, Result, Rilpivirine, ViiV Healthcare

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19

Published: Oct 22, 2020 | Tags: AT-527, Atea Pharmaceuticals, Collaborates, COVID-19, Develop, Roche

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Published: Oct 21, 2020 | Tags: Branaplam, Designation, Disease, Drug, Huntington, LMI070, Novartis, Orphan, receives, U.S.FDA

AWS and Onica Collaborate with Teva to Support its Digihaler Portfolio

Published: Oct 21, 2020 | Tags: AWS, Collaborate, Digihaler, Portfolio, Onica, Teva

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Published: Oct 21, 2020 | Tags: Adults, Candidate, Clinical, GSK, Maternal, Older, Positive, reports, results, RSV, Vaccines

Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Published: Oct 21, 2020 | Tags: Antibody Engineering Technologies, Chugai, License Agreement, Novo Nordisk, Signs

NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 20, 2020 | Tags: Biosimilar, Crohn Disease, NeuClone, P-l Trial, Positive Result, reports, Stelara, ustekinumab

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Published: Oct 20, 2020 | Tags: Cataplexy, EDS, Jazz, Narcolepsy, Oral, P-III, patients, publication, reports, results, Sleep, Solution, study

Samsung Biologics Collaborates with Dinona to Develop DNP-019 for COVID-19

Published: Oct 20,2020 | Tags: Collaborates, COVID-19, Develop, Dinona, DNP-019, Samsung Biologics

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Published: Oct 21, 2020 | Tags: Advances, Clinical, Development, Disease, Late, Parkinson, Prasinezumab, Prothena, Roche, Stage, study

Lilly’s Taltz (ixekizumab) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

Published: Oct 20, 2020 | Tags: Health Canada Approval, ixekizumab, Lilly, Non-Radiographic Axial Spondyloarthritis, receives, Taltz

StageBio Acquires TPL Path Labs to Expand its Footprints Globally

Published: Oct 20, 2020 | Tags: Acquisition, Expands, Global Presence, StageBio, TPL Path Labs

Endo to Acquire BioSpecifics for ~ $540M

Published: Oct 19, 2020 | Tags: $ 540 M, Acquire, BioSpecifics, Endo

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

Published: Oct 19, 2020 | Tags: 111, Bayer, China, Extend, Inc., Vast Blue Ocean of Online Healthcare

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery

Published: Oct 19, 2020 | Tags: AI-Driven, Collaborates, Drug Discovery, Genesis Therapeutics, Roche

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

Published: Oct 20, 2020 | Tags: Adjuvant, AstraZeneca, Cancer, Early, EGFR, Lung, Mutated, osimertinib, reports, results, Stage, Tagrisso, Treatment, US

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Atopic Dermatitis

Published: Oct 19, 2020 | Tags: AbbVie, Atopic Dermatitis, P-lll Study, Rinvoq, Submit Regulatory Application, Upadacitinib, US FDA and EMA

ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

Published: Oct 19, 2020 | Tags: Collaboration, Commercialize, Develop, Greater China, Huadong, ImmunoGen, Mirvetuximab Soravtansine, Signs

Henlius Signs a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 18, 2020 | Tags: $43M, Agreement, bevacizumab, Develop, Diseases, Essex, Henlius, Jointly, License, Ophthalmic, Signs, Treat

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Published: Oct 18, 2020 | Tags: FAD, Isatuximab, Multiple Myeloma, NICE, patients, receives, Recommendation, Sanofi, Sarclisa

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Published: Oct 18, 2020 | Tags: approval, CHMP Positive Opinion, guselkumab, Janseen, PsA, receives, Tremfya

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

Published: Oct 19, 2020 | Tags: approval, AstraZeneca, CHMP, COPD, EU, Maintenance, Recommendation, Treatment, Trixeo, Aerosphere

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

Published: Oct 19, 2020 | Tags: AbbVie, Acute Myeloid Leukemia, receives, US FDA, Approval, Venclexta, venetoclax

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Published: Oct 17, 2020 | Tags: (inclisiran), approval, CHMP, Hypercholesterolemia, Leqvio, Novartis, Positive, Opinion, receives, Treat

Related Post: PharmaShots Weekly Snapshot (Oct 12-16, 2020)

The post PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) first appeared on PharmaShots.

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

.

The post Top 20 Immunology Companies Based 2019 Immunology Segment Revenue first appeared on PharmaShots.

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19

Shots:

  • The companies will collaborate to develop, manufacture, and distribute AT-527 to combat COVID-19. If approved, Atea will be responsible for distributing the treatment option in the US, with the option to request Genentech’s support, and Roche will be responsible for distribution outside the US
  • The therapy is currently being evaluated in P-II study for hospitalized patients with moderate COVID-19 with anticipated P-III initiation in Q1’21, that explores the potential use in patients outside of the hospital setting. Additionally, AT-527 may be developed for post-exposure prophylactic settings
  • AT-527 is an investigational, oral, purine nucleotide prodrug that has demonstrated in antiviral activity against several enveloped single-stranded RNA virus, including human flavivirus and coronavirus

Click here ­to­ read full press release/ article | Ref: Roche | Image: The Times of Israel

The post Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19 first appeared on PharmaShots.

Roche to co-develop remdesivir rival in partnership with Atea

Roche may not be the first company that comes to mind for a COVID-19 treatment, but the Swiss firm is taking a big swing at the market to rival Gilead’s remdesivir. 

The company has joined forces with Atea Pharmaceuticals to develop, manufacture and distribute Atea’s investigational oral direct-acting antiviral AT-527.

AT-527 works by blocking the viral RNA polymerase enzyme needed for viral replication.

It is currently being studied in a phase 2 clinical trial for hospitalised patients with moderate COVID-19. Phase 3 trials are expected to start in Q1 2021, and will test the drug outside of the hospital setting.

If successful, this would make it the first oral treatment option for COVID-19 for patients that are not hospitalised.

If the drug is approved, Atea will be responsible for distributing it in the US, with the option to request Genentech’s support, and Roche will distribute in the rest of the world.

“The ongoing complexities of COVID-19 require multiple lines of defence,” said Bill Anderson, CEO of Roche Pharmaceuticals. “By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and to ease the burden on hospitals during a global pandemic.”

“In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can.”

Roche has been studying its already-approved anti-inflammatory drug Actemra (tocilizumab), branded as RoActemra in some countries, to see if it can cut the chances of COVID patients needing a ventilator.

Until now results have been disappointing – in July the COVACTA trial failed after it showed that Actemra could not improve clinical status in patients with COVID-19.

But the findings of the latest phase 3 study, EMPACTA, could change that after Roche said it plans to share results with the FDA and other regulators to get its label expanded on the basis of the latest results.

Roche has also developed a COVID antibody test, with CEO Severin Schwan branding the state of testing at the start of the pandemic as a “disaster”.

“Some of these companies, I tell you, this is ethically very questionable to get out with this stuff,” Schwan told reporters in a quarterly results conference call.

“It’s a disaster. These tests are not worth anything, or have very little use,” he added.

The release of these tests helped prop Roche up in Q3 as biosimilar rivals took a bite out of its pharmaceutical sales.

The post Roche to co-develop remdesivir rival in partnership with Atea appeared first on .

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

What You Should Know:  

Babyscripts today announced a commercial partnership with
Roche Diagnostics, a division of the world’s largest biotech company and a
global pioneer in pharmaceuticals and diagnostics. 

– Roche will partner with Babyscripts on the
development of Babyscripts’ remote patient monitoring (RPM) programs to
leverage groundbreaking data science through the next generation of RPM in
pregnancy. 


Babyscripts, a
Washington D.C.-based virtual care platform for managing obstetrics, today
announced a commercial partnership with Roche
Diagnostics
, a division of the world’s largest biotech company and a
global pioneer in pharmaceuticals and diagnostics. Roche Diagnostics and Babyscripts will collaborate on the next generation of
digital and diagnostic combinations in women’s health.

Commercial Partnership to Power Next-Generation of RPM in
Pregnancy

Under the terms of this collaboration,
Roche will partner with Babyscripts on the
development of Babyscripts’ remote patient
monitoring (RPM) programs to leverage groundbreaking data science through the
next generation of RPM in pregnancy. These programs will be focused on solving
issues of blood pressure-related complications through RPM, such as prenatal
hypertension. Babyscripts participated in Startup
Creasphere
, Roche’s digital health accelerator
program, which was instrumental in initiating this collaboration.

Babyscripts Virtual
Care Platform Background

Babyscripts has spent
the last six years building a clinically-validated, virtual care platform to
allow OBGYNs to deliver a new model of prenatal and postpartum care. Using
internet-connected devices for remote monitoring, Babyscripts offers
risk-specific experiences to allow providers to manage up to 90% of pregnancies
virtually, allowing doctors to detect risk more quickly and automate elements
of care.

“Roche’s investment in Babyscripts solutions is a tremendous validation of our vision for improving maternal care, and an example of the kind of strategic collaboration essential to moving the needle on outcomes,” said Juan Pablo Segura, co-founder and President of Babyscripts. “Roche’s vast expertise in the field of women’s health diagnostics and clinical science combined with our on-the-ground experience in the virtual maternal health space is going to prove a game changer for rethinking how we approach prenatal and postpartum care.”

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Shots:

  • The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study
  • The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients with early Parkinson’s disease on stable levodopa therapy and is expected to initiate in 2021
  • Prasinezumab is the first anti-alpha synuclein Ab to advance into late-stage development. Additionally, Prothena will earn a $60M clinical milestones upon the first patient dosed in the study

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: New Hope Network

The post Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease first appeared on PharmaShots.

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery

Shots:

  • Genesis to receive an up front and is eligible to receive pre/ clinical and regulatory milestones along with royalties on sales of approved drugs emerges from the collaboration
  • The collaboration leverages Genesis’ graph machine learning and drug discovery expertise to identify drug candidates for therapeutic targets across multiple disease areas
  • Genesis has developed Dynamic PotentialNet and other neural network algorithms, examining drug-target complexes as flexible, spatial graphs, with the advantage of superior potency and selectivity prediction uniquely toward novel, previously undruggable targets and characterized therapeutic targets

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

The post Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery first appeared on PharmaShots.

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies.

The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results.

But accelerated approval is only a temporary measure and manufacturers must provide confirmatory survival and safety data from large trials so drugs can remain on the market in the long term.

The FDA’s approval covers use of Venclexta (venetoclax) in combination with azacytidine, or decitabine, or low-dose cytarabine (LDAC) for newly diagnosed AML in adults 75 years or older, or who have comorbidities preventing intensive induction chemotherapy.

The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients.

Approval of the combination therapies is based on the results of two phase 3 studies, VIALE-A and VIALE-C.

Overall survival from the 431-patient VIALE-A trial showed Venclexta plus azacitidine significantly reduce risk of death by 34% compared with azacytidine alone, with a median overall survival of 14.7 months compared with 9.6 months in the control group.

Those treated with Venclexta had significantly higher rates of complete remission with 37% achieving this compared with 18% in those treated with azacitidine alone.

Results of the trial have led to the combination being included in guidelines for treatment of AML by the US National Comprehensive Cancer Network.

The most frequent serious adverse reactions reported in 83% of people treated with Venclexta plus azacitidine, were low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal; 19%) and bleeding (6%).

The Venclexta and LDAC combination was approved based on the 211-patient VIALE-C study which showed 27% of people treated receiving Venclexta plus LDAC achieving a completed remission compared with 7.4% receiving LDAC alone.

Overall survival results were not statistically significant, with the median OS in the Venclexta plus LDAC group being 7.2 months compared with 4.1 months for those treated with LDAC alone.

The most frequent serious adverse reactions reported in 65% of people treated with Venclexta plus LDAC, were pneumonia (17%), low white blood cell count with fever (16%), and blood infection (excluding fungal; 12%).

Venclexta is being developed by AbbVie and Roche’s Genentech unit and is jointly marketed by the companies in the US, and by AbbVie outside of the US.

The post FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies 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.

COVID-19 tests prop up Roche as US biosimilars bite in Q3

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes.

Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US.

Avastin was down 30% compared with the same quarter last year, generating revenues of just under 1.2 billion Swiss francs ($1.3 billion)

There was a similar story with MabThera/Rituxan, which was down 33% to just over CHF 1 billion ($1.1 billion) for the quarter, and Herceptin’s sales dipped 38% to CHF 879 million ($947 million).

In the past three years Roche has enjoyed one of the most successful drug launches of all time with MS drug Ocrevus, but this has not been enough to offset the falling sales from these cancer drugs which at their peak generated yearly sales in excess of $20 billion.

All three are facing competition from several different biosimilars in the US, which have come to market over the last couple of years and after the cut price competitors hit the European market.

Biosimilars are near-copies of complex biologic drugs that are shown to be as safe and effective as the originator with a series of rigorous trials and tests.

They are not sold at the rock-bottom prices seen with generics of small molecules but can save health systems billions by undercutting the price of the expensive biologics.

Sales for the pharma division slipped 4% to just over CHF 11.1 billion ($11.95 billion) for the quarter.

Surging sales from the company’s diagnostics division, which has been busy because of demand for tests during the COVID-19 pandemic, meant that sales for the group were broadly flat in the quarter.

The diagnostics division saw an 18% increase in revenues to just under CHF 3.6 billion ($3.9 billion), meaning that at constant exchange rates the company’s sales were up 1$ to CHF 14.7 billion ($15.8 billion).

Overall the company saw strong sales in the first quarter followed by a COVID-19 related decline in Q2, with sales stabilising in Q3 thanks to stronger sales of new medicines and demand for coronavirus tests.

Confirming the company’s 2020 outlook, CEO Severin Schwan noted the FDA approvals for three new medicines: Enspryng and Evrysdi for rare diseases and the cancer medicine Gavreto.

Roche is also working with Regeneron on the REGN-COV2 antibody cocktail, which the FDA is reviewing for an Emergency Use Authorization for COVID-19.

The post COVID-19 tests prop up Roche as US biosimilars bite in Q3 appeared first on .

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Shots:

  • Dyno to receive upfront and is eligible to receive ~$1.8B milestones including development and commercial milestones along with royalties on any product emerges during the collaboration
  • Dyno will be responsible for the design of novel AAV capsids with improved functional properties for gene therapy while Roche and Spark will conduct preclinical, clinical, and commercialization activities for the products using the novel capsids
  • The collaboration leverages Dyno’s CapsidMap platform for the development of next-generation AAV vectors for CNS diseases and liver-directed therapies for the portfolio of both Roche and Spark

    Click here to­ read the full press release/ article | Ref: Dyno Therapeutics | Image: Oncology Nurse Advisor

The post Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~.8B first appeared on PharmaShots.

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

The post Roche working “around the clock” to tackle UK test supply problems appeared first on .

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

The post Roche working “around the clock” to tackle UK test supply problems appeared first on .

Roche pays $200m for Vaccibody’s cancer vaccine drug

Roche’s Genentech unit has paid $200 million to develop an individualised cancer vaccine with Norwegian biotech Vaccibody, which focuses on targets known as neoantigens that spring up as tumours grow and mutate.

The deal with the Oslo-based company is worth up to $715 million, with potential milestone payments worth up to $515 million on top of the $200 million in near-term payments.

Vaccibody, which is also entitled to tiered royalties on sales of any marketed products, will develop the DNA-based individualised neoantigen vaccines until the end of phase 1b.

Genentech, which is already well established as a player in cancer immunotherapy with its PD-L1 class drug Tecentriq (atezolizumab), will be responsible for development and marketing thereafter.

The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

Vaccibody has been working on a targeted DNA-based vaccine platform, in a bid to find a potential new treatment paradigm for individualised cancer vaccines.

The deal focuses on Vaccibody’s investigational product VB10.NEO, which is designed to be produced on-demand according to the neoantigen profile of an individual patient and produces an immune response that attacks the tumour.

Neoantigens are only found on tumours and are therefore an attractive target for cancer immunotherapy as they may be recognised as foreign by the immune system, while leaving healthy tissue untouched.

Vaccibody is not the only company that is trying to make immunotherapies that target neoantigens: in the UK, Cambridge-based NeoPhore is looking at ways to encourage cancers to produce these mutations to broaden the potential immune response against cancer.

Frame Therapeutics has also begun work on neoantigen-based cancer vaccines based on RNA technology.

Earlier this year it began a research collaboration with eTheRNA, which is developing cancer therapies based on its proprietary mRNA technology.

And last year Tokyo-based NEC Corporation and VAXIMM began a neoantigen collaboration using the former’s artificial intelligence technology and the latter’s T-cell immunotherapy technology.

The post Roche pays $200m for Vaccibody’s cancer vaccine drug appeared first on .

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

Coronavirus pharma news round-up 21/08/20

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues.

Here we highlight the biggest R&D, market access and digital coronavirus news of the past week.

  • Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.
  • Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses? This is a question that a consortium of European pharma companies hopes to answer as it aims to rapidly develop new therapies to combat the pandemic.
  • Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.
  • Smell and taste loss associated with COVID-19 differs from that experienced by patients with common colds or flu, according to researchers who said the symptom could be used to quickly identify coronavirus infections in settings such as airports or emergency departments.
  • Health Secretary Matt Hancock is planning to dissolve Public Health England and replace it with a new agency dedicated to responding to pandemics, according to reports. The plan is to implement a new body modelled on the independent Robert Koch Institute in Germany, which has been held up as having done well in weathering COVID-19, in part at least because of a well-organised and large-scale testing programme early on.
  • Shares in Netherlands biotech Kiadis rose sharply on the news that it would start developing a natural killer (NK) cell therapy for COVID-19, but later lost most of the gains on what looks like profit-taking.
  • 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.

 

The post Coronavirus pharma news round-up 21/08/20 appeared first on .

Mission successful for Novartis after FDA approves ofatumumab in MS

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed.

The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

Kesimpta will have a list price of around $83,000 a year, which the company argues will make it one of the lowest-cost branded options in a highly competitive market where drugs like Sanofi’s Aubagio and Roche’s Ocrevus have strong footholds.

Novartis is also talking up Kesimpta’s “favourable” safety profile and an injector pen that allows the drug to be administered each month at home.

The company hopes this will give it a competitive advantage over Roche’s Ocrevus (ocrelizumab), which is given as an infusion every six months in a hospital clinic after two starter doses two weeks apart.

Novartis also pointed to trial data showing better efficacy and similar safety profile when compared with Sanofi’s oral MS drug Aubagio (teriflunomide).

Ofatumumab was first approved by the FDA as a cancer drug in chronic lymphocytic leukaemia (CLL), under the brand name Arzerra, in 2014 when it was owned by GlaxoSmithKline.

But Novartis took control of ofatumumab in 2015 as part of an asset-swap deal, picking up rights to its other uses in autoimmune diseases such as MS, and has completed a research project lasting around 10 years to reimagine the drug as a treatment for MS.

Patients taking the drug for CLL in the US will be transitioned over to an access programme at no cost.

Novartis will pay co-developer Genmab a lump sum of $30 million as payment for lost royalties.

Kesimpta works by targeting B-cells, which are the underlying cause of both multiple sclerosis and several kinds of blood cancer including CLL.

Approval of Kesimpta is based on results from the phase 3 ASCLEPIOS I and II studies, in which it demonstrated superiority versus Aubagio in significantly reducing the annualised relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.

The post Mission successful for Novartis after FDA approves ofatumumab in MS appeared first on .

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection.

The new guidance recommends Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine, for adults with diffuse large B-cell lymphoma (DLBCL), in second line when patients cannot have a stem cell transplant.

Around 4,800 people in England have DLBCL and around 530 of these will be eligible for the treatment.

NICE had rejected the treatment in previous draft guidance, but Roche has since offered an “updated commercial agreement” – likely a further confidential price cut – and offered further analyses relating to long-term survival data.

This has swayed NICE, which says it considers Polivy to be a cost-effective use of NHS resources.

NICE cited clinical trial evidence showing that in 40 patients treated with Polivy combination it caused cancer to become undetectable in around 40% of the cohort, compared with around 18% of the 40 patients treated with rituximab and bendamustine alone.

While NICE conceded there is uncertainty in the long-term data on remission, the evidence also suggested the combination treatment may increase progression-free survival and overall survival compared with rituximab and bendamustine.

DLBCL accounts for two in five non-Hodgkin’s lymphoma (NHL) cases in the UK. It is an aggressive disease that progresses rapidly, with a significant negative impact on the quality of life of patients.

Delivered intravenously every three weeks, the average cost of a course of the combination treatment is £50,416 at its list price, but the company offered the NHS a confidential discount.

Final guidance is expected to be published next month.

Pia Ballschmieter, haematology franchise lead, Roche Products Limited said: “People with relapsed or refractory diffuse large B-cell lymphoma have limited treatment options, especially those who are not candidates for haematopoietic stem cell transplant.

“We are proud to have collaborated with the clinical community and NICE to ensure that, from now on, people are able to benefit from Polivy, which represents a step forward in the treatment of this disease.”

Polivy is a first in class antibody drug conjugate, which targets the CD79b protein expressed on the majority of B-cells that cause NHL.

It binds to CD79b and delivers a cytotoxic agent resulting in cell death.

 

The post NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy appeared first on .

Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.

Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, but has admitted that it won’t be able to meet the expected demand for the drug on its own.

The agreement with Roche will “substantially” increase the number of doses available if the drug works in clinical trials.

REGN-COV2 was the first therapeutic to be backed under the Trump administration’s Operation Warp Speed, which previously had focused only on coronavirus vaccines.

It is being tested in phase 2/3 trials both as a treatment for coronavirus infections as well as prophylaxis against infection in people exposed to SARS-CoV-2, with initial results expected before the end of September.

The US deal envisaged 70,000 to 300,000 therapeutic doses of the drug being made available by September, equivalent to 420,000 to 1.3 million prevention doses.

Under the terms of the agreement, each company has committed to dedicate a portion of its production capacity to REGN-COV2 each year.

The two partners think that by working together they could increase capacity to provide up to 2 million therapeutic or 8 million prophylactic courses a year.

Meanwhile, in addition to chipping in for its production, Roche also gets distribution rights to the antibody cocktail outside the US, in return for jointly funding and carrying out the phase 3 stage of the prevention trial as well as phase 1 healthy volunteer safety studies outside the US.

The Swiss drugmaker will also take responsibility for filing REGN-COV2 outside the US and carrying out any trials needed in those countries. Profits from the drug will be split, with Regeneron’s share expected to be in the 50% to 60% range.

REGN-COV2 was developed by Regeneron based on tests in mice genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.

The cocktail targets two components in the spike protein on SARS-CoV-2, the virus that causes COVID-19, with the aim of preventing attachment of the virus to host cells and interrupting infection.

The same approach has been used in the development of Regeneron’s Ebola candidate REGN-EB3, which is under review at the FDA with a verdict due in October.

The post Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2 appeared first on .

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Shots:

  • The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies
  • Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease worsening or death (PFS); @primary analysis, median survival follow up time (8.6mos.); 7.6mos. delay in median time to deterioration of patient-reported QoL
  • The approval is part of Project Orbis, an initiative of the FDA’s OCE which provides a framework for simultaneous submission and review of oncology products among international partners

Click here ­to­ read full press release/ article | Ref: Roche | Image: SOM

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots:

  • The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further
  • Regeneron will lead the distribution in the US while Roche will be responsible for the distribution outside the US, both will bear distribution expenses in their designated territories. Each partner will dedicate a manufacturing capacity to REGN-COV2 every year while the collaborators have started the technology transfer process
  • The partners will jointly fund and execute the ongoing P-III prevention and P-I healthy volunteers safety studies as well as additional global studies to assess the potential for REGN-COV2 against COVID-19. Additionally, Roche will solely responsible for the initial EMA’s approval or conducting any additional studies required for approval outside the US

Click here ­to­ read full press release/ article | Ref: Roche| Image: StraitTimes

Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

New strategy, new outlook: Sanofi takes another step, gains full control over the Principia’s MS treatment 

Sanofi has inked a definitive agreement with Principia Biopharma to acquire the company, all of its outstanding shares, and its BTK inhibitors in a deal worth USD 3.68 Billion. The deal is expected to complete in the fourth quarter of 2020.

The acquisition will help Sanofi transform its R & D and accelerate the discovery and manufacturing of novel medications in areas with significant unmet needs. 

Principia’s experimental Bruton tyrosine kinase (BTK) inhibitors will help Sanofi leverage the inhibitors’ ability to block the signaling pathways of the immune system, thus preventing the inflammation and tissue damage due to autoimmune diseases. Sanofi had been in business-relation with Principia for a long time now.

Sanofi had earlier licensed-in Principia’s experimental multiple sclerosis treatment ‘168; the late-stage pemphigus treatment Rilzabrutinib; and PRN473, a topical BTK inhibitor.

Last year in December, the company had proposed to change its outlook to favor more lucrative areas, i.e., cancer research and abandon diabetes and cardiovascular research. The company had taken several steps, including the decision to spin off its API unit and divest in Regeneron to realize its goal. 

Make way for Roche: FDA’s okay to Roche’s NMOSD oral treatment Enspryng 

Roche has received the recommendations from the US FDA for its subcutaneous treatment Enspryng for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The drug is approved in Canada, Japan, and Switzerland for NMOSD. However, it is under review in the EU and China.

Administered orally, Enspryng is a humanized monoclonal antibody. The drug targets and inhibits interleukin-6 (IL-6) receptor believed to play a vital role in NMOSD-associated inflammation.

Often misdiagnosed as multiple sclerosis, Neuromyelitis optica spectrum disorder (NMOSD) is a life-long, chronic disorder of the brain and spinal cord that inflammation the optic nerve (optic neuritis) and the spinal cord (myelitis), causing blindness, muscle weakness, and paralysis.

USD 475 Million Deal: BMS Inks An A Global License Deal With Dragonfly For Immunotherapy Program 

Bristol Myers Squibb announced a definitive agreement with Dragonfly Therapeutics to gain global exclusive rights Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program for treating solid and hematological cancers.

BMS is paying approximately USD 475 million to license Dragonfly Therapeutics’ interleukin-12 (IL-12) immunotherapy program. This program is the early-stage experimental med DF6002, a monovalent IL-12 immunoglobulin Fc fusion protein. It functions by inducing an inflammatory tumor microenvironment to boost anti-tumor responses. The program includes DF6002, which is a monovalent IL-12 immunoglobulin Fc fusion protein.

Recently, Dragonfly dosed its first patient in a Phase 1/2 study of the Company’s proprietary IL12 investigational immunotherapy, DF6002. BMS now plans to advance the studies and research further exploring Dragonfly’s immunotherapy program. 

The post Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal appeared first on DelveInsight Business Research.

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Shots:

  • The approval is supported by P-III SAkuraStar and 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
  • The studies demonstrated robust efficacy and a favorable safety profile in adults with AQP4 Ab positive NMOSD. relapse-free patients @96wks. (76.5% & 91.1% vs 41.1% & 56.8%)
  • Enspryng is the first and only FDA-approved SC treatment option for AQP4 Ab positive NMOSD that can be self-administered by a patient or a caregiver every four weeks. The therapy is mAb targeting IL-6 that utilizes recycling antibody technology and will be available in the US in two wks.

Click here ­to­ read full press release/ article | Ref: Roche | Image: HKU E-Learning Platform

Related Post: Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

Roche takes on Alexion as FDA approves satralizumab in NMOSD

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng.

Roche is taking on Alexion’s blockbuster Soliris (eculizumab), which was approved in NMOSD last year and in June Viela Bio, a spinoff from AstraZeneca, also won approval for another rival, Uplinza (inebilizumab).

The big Swiss pharma had been hoping for approval in patients regardless of whether they have anti-aquaporin-4 (AQP4) antibodies.

But so far Roche has not produced enough data in the broader patient group and the FDA has instead approved Enspryng in patients producing the AQP4 antibodies.

However Roche is claiming an advantage over Soliris with a more patient-friendly administration regimen: Enspryng can be self-administered by a patient or a caregiver every four weeks.

Patients taking Soliris have to visit a clinic to get an injection via a drip every week for five weeks, then every fortnight.

Uplinza offers another easier option as it is infused every six months after two starter doses two weeks apart.

Roche has yet to release any information on Enspryng’s price, but has plenty of room to manoeuvre given Soliris’ list price of around $500,000 per year.

Enspryng has a different mechanism of action from Soliris too: Roche’s drug inhibits the IL-6 receptor that is believed to play a key role in inflammation associated with NMOSD while Soliris targets the complement system.

It was designed by Chugai, part of the Roche group, using antibody technology allowing for longer circulation and subcutaneous dosing every four weeks.

NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve and spinal cord, causing blindness, muscle weakness and paralysis.

Roche said that NMOSD will be launched in two weeks.

This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies.

In those studies Enspryng showed robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody positive NMOSD.

Results were sustained for 96 weeks, significantly reducing the risk of relapse compared with placebo as a monotherapy and when used concurrently with baseline immunosuppressant therapy (IST), which has commonly been used to manage NMOSD symptoms associated with relapses.

The post Roche takes on Alexion as FDA approves satralizumab in NMOSD appeared first on .

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

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

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

FDA to decide on TG Therapeutics’ lymphoma drug early next year

The FDA has accepted TG Therapeutics’ filing for its lymphoma drug umbralisib, which if approved could compete against a combination therapy from Bristol-Myers Squibb and Roche.

TG’s filing covers previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL), competing against a combination of BMS’ Revlimid (lenalidomide) and Roche’s Rituxan (rituximab), known for short as R2.

An investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, umbralisib will receive a faster six-month Priority Review in MZL and a standard 10-month review in FL.

This gives decision dates of 5 February and 15 June for the MZL and FL indications, respectively.

The filing was based mainly on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL phase 2b trial evaluating patients with relapsed/refractory MZL or FL.

The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen, such as Rituxan.

The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent.

Each cohort met its primary endpoint of overall response rate (ORR), meeting the Company’s target guidance of 40-50% ORR, as confirmed by an Independent Review Committee.

The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

MZL is a catch-all term for a group of slow growing mature B-cell non-Hodgkin lymphomas (NHLs) and is considered a chronic and incurable disease.

There are around 7,500 newly diagnosed patients each year in the US and is the third most common B-cell NHL, accounting for around 8% of cases.

MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).

FL is usually a slow-growing NHL that arises from B-lymphocytes, is generally incurable, but patients can live for many years with it.

It accounts for around 20% of NHL cases, with 15,000 newly diagnosed patients each year in the US.

The post FDA to decide on TG Therapeutics’ lymphoma drug early next year appeared first on .

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved, Xolair’s prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pinterest

Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Shots:

  • Celleron will receive an exclusive global right for the clinical development, manufacturing, and commercialization of emactuzumab (formerly RG7155 and RO5509554). The companies expect the closing of an agreement by the end of 2020
  • 86% of TGCT patients treated with emactuzumab responded to the drug, with 68% of people experiencing a PR within 6 weeks of starting the treatment. The license agreement demonstrated Celleron’s dedication to the development of cancer medicine and its transformational potential for patients inflicted with cancer
  • Emactuzumab (RG7155) is an IgG1 mAb, designed to target and deplete macrophages in the tumor tissue.  The therapy targets TAMs by binding to CSF-1R on the cell surface and blocking its activation by CSF-1

Click here ­to­ read full press release/ article | Ref: Celleron Therapeutics | Image: PharmaShots

Celleron targets Daiichi Sankyo with Roche’s unwanted rare cancer drug

UK biotech Celleron Therapeutics has bought a licence to develop, manufacture and market emactuzumab, an unwanted drug from Roche’s pipeline that could be used in a rare tendon sheath cancer already targeted by Daiichi Sankyo.

Emactuzumab is a monoclonal antibody designed to target and deplete macrophages, a kind of white blood cell, in tumour tissue.

These tumour-associated macrophages (TAMs) have been enlisted by the tumour and suppress the local immune system and promote growth of cancer cells.

Roche decided to axe development of emactuzumab in 2018 after a combination with its immunotherapy Tecentriq (atezolizumab) did not show any improvement over Tecentriq monotherapy in solid tumour trials.

At the time Roche said it was considering out-licensing the drug as it recognised it could be used in diffuse tenosynovial giant cell tumour (TGCT), a rare cancer caused when macrophages proliferate in the synovial tissue in the joint and tendon sheath.

While TGCT is not a priority for Roche, Celleron said that it plans to develop emactuzumab in the indication after it showed a favourable safety profile and “encouraging” efficacy.

The deal is expected to close later this year and no financial details were disclosed.

Emactuzumab specifically targets TAMs by binding to colony-stimulating factor-1 receptor (CSF-1R) on the cell surface and blocking its activation by CSF-1.

The cancer is driven by overexpression of CSF-1 and massive recruitment of CSF-1R-expressing macrophages, which form a tumorous mass.

Even though the cancer rarely metastasises, it is locally aggressive and disabling.

Standard therapy is surgery but relapse rates are high and patients’ quality of life are impacted by tumour-related symptoms and problems after surgery.

Last year Daiichi Sankyo became the first company to market a targeted treatment for TGCT, after the FDA approved its Turalio (pexidartinib), although this carries a boxed warning about the risk of serious and potentially fatal liver injury.

Celleron is also developing CXD101, a drug to treat a certain kind of colorectal cancer, following a separate licensing agreement with AstraZeneca.

The phase 2 CAROSELL trial began early this year, testing Bristol-Myers Squibb’s immune-oncology agent nivolumab (Opdivo) in combination with CXD101, in advanced micro-satellite stable colorectal cancer (MSS CRC).

 

The post Celleron targets Daiichi Sankyo with Roche’s unwanted rare cancer drug appeared first on .

FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy 

Spinal Muscular Atrophy Market

The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in muscle atrophy, in adults and children two months of age and older.

Evrysdi is orally administered and was evaluated in a broad clinical trial program with patients range from birth to 60 years old, including difficult-to-treat populations whose disease had progressed. It is a survival motor neuron-2 (SMN-2) splicing modifier, designed to increase and sustain SMN protein levels throughout the central nervous system and peripheral tissues. It is under investigation in two clinical studies for Types 1, 2, and 3 SMA. The drug showed improvement in both the trials. The drug improved survival without permanent ventilation at 12 and 23 months compared to natural history.

Before Evrysdi, Biogen’s Spinraza and Novartis’ Zolgensma are already approved and commercially available in the Spinal muscular atrophy market; however, it’s comparatively lower price and oral administration route will benefit the drug to expand in the SMA market. 

Roche’s Gut Disease Drug, Etrolizumab Presents Muddled Results in Ulcerative Colitis Trials 

Ulcerative Colitis Market

Genentech has been running a major clinical trial program, studying its first-ever investigational therapy, Etrolizumab, to treat Ulcerative Colitis. The results from the trials evaluating Etrolizumab as induction therapy and as maintenance therapy posted by the company appeared mixed.

The results from the Phase III HIBISCUS I induction study, etrolizumab met the primary endpoint in patients without prior anti-tumor necrosis factor (anti-TNF) treatment; however, in the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint.

In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab managed to meet the primary endpoint at induction, but at maintenance, it failed. In the LAUREL maintenance study in people without previous anti-TNF treatment also etrolizumab was unable to meet its primary endpoint.

Etrolizumab is an antibody engineered to block two members of a family of proteins called integrins to stop immune overreaction by preventing the WBCs to enter into the gut.  

Secura Bio Secures the Global Commercial and Development Rights to Copiktra from Verastem

Verastem, a biopharma company advancing cancer treatments, has signed a definitive agreement with Secura Bio to sell its global commercial and development rights to COPIKTRA (duvelisib). Moreover, Secura also has received rights to Verastem’s oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma. 

Oncology Market

Under the terms of the agreement, Verastem will receive an up-front amount of USD 70 Million, with a total deal value of up to USD 311 Million and royalties on sales. For smoother transactions, Secura has taken a USD 70 Million financing by  Athyrium Capital Management. Secura will fund the ongoing trials and projects of Verastem to develop VS-6766 and Defactinib in Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer at least until 2024. 

Secura plans to reinforce the development of Copiktra in the treatment of T-cell lymphomas, and exploit PI3K and HDAC inhibitors for additional value in the trial outcomes. 

The post FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem appeared first on DelveInsight Business Research.

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out

Roche’s late-stage trial programme for ulcerative colitis candidate etrolizumab has generated some positive and negative results, but leans firmly towards the latter.

The Swiss drugmaker has acknowledged that the dual-acting anti-integrin antibody – which is trying to chase down Takeda’s blockbuster Entyvio in UC – generated “disappointing” results from the programme, which is billed as the largest ever undertaken in inflammatory bowel disease (IBD).

On the plus side, etrolizumab met the primary endpoint of improving remission compared to placebo in HIBISCUS I – which enrolled UC patients who hadn’t previously been treated with anti-TNF drugs, a go-to therapy for the disease.

Unfortunately for Roche, the drug failed to match that performance in a confirmatory trial in the same patient population (HIBISCUS II), and was no better than placebo at maintaining remission in these patients, according to the LAUREL study.

Finally, in the HICKORY trial involving patients previously treated with anti-TNF drugs, the antibody was able to beat placebo at inducing remission, but once again was no better at maintaining that response.

With one and a half positive results out for four from the phase 3 programme, the future of etrolizumab in UC looks in doubt, although Roche is still testing the drug in a pivotal study in Crohn’s disease, another form of IBD, with and without prior anti-TNF treatment.

Roche’s chief medical officer Levi Garraway said the company is “analysing these data to learn more about how we might address the needs of people with this devastating disease.”

There’s no hiding that the data is a big setback for Roche as it goes after Entyvio (vedolizumab), another integrin-targeting antibody that has become a go-to treatment for UC after besting AbbVie’s TNF drug Humira (adalimumab) in the VARSITY head-to-head study. Takeda reported sales of more than 101 billion yen ($945 million) for its drug in the three months ended 30 June.

Entyvio targets the alpha-4 beta-7 integrin, and Roche had gambled that blocking a second target (alpha-E beta-7 integrin) with etrolizumab would improve its efficacy.

As it stands, the biggest challenger to Takeda’s drug is now Johnson & Johnson’s IL-2/IL-23 inhibitor Stelara (ustekinumab), which was approved for UC last year and according to market research firm Spherix has had a strong roll-out in the new indication.

Also heading through the UC pipeline are oral JAK inhibitors from Gilead and AbbVie, oral S1P inhibitors from Bristol-Myers Squibb and Arena, and new biologics including selective IL-23 inhibitors from AbbVie, J&J and Eli Lilly.

Roche has often also been listed as a key challenger in what looks set to become an increasingly challenging and competitive UC market in the coming years, particularly as the drug is administered as a once monthly subcutaneous injection rather than intravenously. Now, that looks much less likely.

The post Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out appeared first on .

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Shots:

  • In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance
  • In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its 1EPs while the safety profile of therapy was consistent with previous studies and no major safety issues were reported till date in the four P-III studies
  • The therapy is currently being evaluated as an induction/maintenance treatment in people with mod. to sev. active CD with/out prior anti-TNF treatment in a global P-III study (BERGAMOT) and OLE and safety monitoring study (JUNIPER), involving 1,100+ people with CD. In addition, Roche is studying other therapies in IBD and is committed to further understanding this disease

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pantone Canvas Gallery

Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam).

Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec).

But Spinraza costs $750,000 in the first year of treatment and about half that price annually from then on.

Zolgensma costs about $2.1m for a single shot of the gene therapy, making it the most expensive drug in the world by many people’s reckoning, although the manufacturer argues this is justified given the costs of treating the condition in later life.

Roche has decided to price Evrysdi according to its weight, costing up to $340,000 per year, with the cost being under $100,000 annually for some younger patients.

While this is not cheap by anybody’s reckoning, Roche hopes that the less intimidating price tag, plus the patient-friendly oral administration method will give it a competitive edge.

The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

Roche noted that Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA.

Infants achieved the ability to sit without support for at least five seconds, a key motor milestone not normally seen in the natural course of the disease.

Evrysdi also improved survival without permanent ventilation at 12 and 23 months, compared to natural history.

A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.

Evrysdi is designed to treat SMA by increasing production of the survival of the motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Evrysdi will be available in the US within two weeks for direct delivery to patients’ homes through Accredo Health Group, an Express Scripts specialty pharmacy.

The post Roche takes on pricey rivals as FDA approves SMA drug appeared first on .

Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Shots:

  • The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum of people living with SMA: FIREFISH in symptomatic infants aged 2-7 mos, and SUNFISH in children and adults aged 2-25yrs.
  • The two studies demonstrated improvements in motor function in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA. The filing of MAA to EMA for the therapy is imminent while the therapy has been filed in Brazil, Chile, China, Indonesia, Russia, South Korea, and Taiwan
  • Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics and is the only therapy for SMA that can be taken at home. It will be available in the US within 2wks. for direct delivery to patients’ homes through Accredo Health Group

Click here ­to­ read full press release/ article | Ref: Roche | Image: PharmaShots

Roche’s Tecentriq flunks triple-negative breast cancer trial

Roche’s hopes of extending the use of its PD-L1 inhibitor Tecentriq in triple-negative breast cancer (TNBC) have been dashed by a late-stage trial failure looking at the drug in combination with chemotherapy.

Adding Tecentriq to treatment with paclitaxel as a first-line treatment for TNBC patients whose tumours expressed the biomarker PD-L1 did not lengthen the time it took for the cancer to progress, when compared to paclitaxel plus placebo.

Moreover, there was a trend towards worse overall survival with Roche’s drug in the IMpassion131 study, although the company says the data on this are still immature and statistically underpowered.

TNBC is so called because it lacks the biomarkers that other targeted therapies can latch on to.  It is more aggressive than other types of breast cancer, accounting for 15-20% of cases but causing 25% of deaths.

Tecentriq was the first drug among checkpoint inhibitors to get approval in TNBC, although rivals are circling, notably Merck & Co / MSD’s Keytruda (pembrolizumab).

“Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens,” said Roche’s chief medical officer Levi Garraway.

Roche’s drug is already licensed in more than 70 countries as a front-line treatment for PD-L1-positive forms of TNBC in a regimen with Bristol-Myers Squibb’s Abraxane (nab-paclitaxel) – a form of paclitaxel bound to the blood protein albumin to improve its delivery side effects – based on the IMpassion130 trial.

Tecentriq has had the frontline TNBC immunotherapy market to itself since it was approved last year, but is facing direct competition from Keytruda (pembrolizumab) in the wake of the KEYNOTE-355 trial reported in May.

That study showed Merck’s drug plus chemo reduced the risk of disease progression or death by 35% compared to chemo alone in PD-L1-positive TNBC, and will form the basis of regulatory filings later this year.

There’s little doubt that the arrival of Keytruda on the TNBC market would have an impact on Roche’s ambitions in this area, given the drug is the top-selling PD-1/PD-L1 inhibitor.

Failure in IMpassion131 puts a brake on growth in an indication that Roche has suggested could be worth $1 billion in sales on its own for Tecentriq, which brought in around $2 billion for Roche last year across its approved uses in TNBC, bladder and various forms of lung cancer.

It’s not all been bad news for Tecentriq of late, however. In June, Roche scored a major win for Tecentriq as a pre-surgery (neoadjuvant) therapy for TNBC patients – regardless of their PD-L1 status – on the back of the IMpassion031 trial, and is in the build-up to regulatory filings in this indication.

That would open up a much larger eligible patient population for the drug and extend its use into the 60% of TNBC patients with low PD-L1 expression levels. Merck is lurking in the wings in the neoadjuvant setting too though, thanks to the results of KEYNOTE-522 reported last year.

So far, none of the PD-1/PD-L1 inhibitors have been approved for neoadjuvant or adjuvant (post-surgery) use in any form of cancer.

The post Roche’s Tecentriq flunks triple-negative breast cancer trial appeared first on .

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots:

  • The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC
  • The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed a negative trend, however, the study was not powered for the 2EPs of OS and data were immature at the time of analysis while OS follow-up is planned to continue until the final analysis
  • In the previous IMpassion130 study, Tecentriq + Abraxane demonstrated PFS benefit and, while not formally tested, showed improvements in OS for people with metastatic TNBC whose tumors express PD-L1

Click here ­to­ read full press release/ article | Ref: Roche | Image: Forbes

Related News: Roche’s Tecentriq (atezolizumab) + Abraxane Receive European Commission’s Approval for Patients with PD-L1-Positive Metastatic Triple-Negative Breast Cancer




Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

Shots:

  • The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV
  • The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and has been calibrated to WHO’s international standard
  • The test has received the FDA’s BDD and has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL-1E+08 IU/mL in EDTA plasma

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fedaiisf




Redx shares soar after IPF drug licence deal with AstraZeneca

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca.

The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015.

AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF).

Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial.

The biotech based at AZ’s former UK R&D site in Alderley Park, Cheshire, could receive a further $360 million in development and commercial milestones plus tiered royalties.

Redx is also eligible for tiered royalties of mid-single digit percentages, based on any future net sales.

In the meantime Redx will continue to develop its lead cancer drug, RXC004, which is also a porcupine inhibitor and is in a phase 1/2 clinical trial.

US-based investment group Redmile acquired Redx earlier this year, and Redx finances were put on a firmer footing when it raised $30m by issuing convertible loan notes to Redmile Group and Sofinnova at the end of June.

The deal consisted of a $29m loan and a $1m investment and gave the company enough funding to carry on its R&D work into next year.

The RXC006 deal makes sense for AstraZeneca, which has respiratory diseases as one of its main focus areas, although IPF is being targeted by other pharma companies too.

Mene Pangalos, executive vice president BioPharmaceuticals R&D, AstraZeneca said: “Fibrotic diseases such as idiopathic pulmonary fibrosis have significant impact on patients’ lives and new therapies are urgently needed.

“We look forward to progressing this porcupine inhibitor into clinical trials as a novel approach to suppress Wnt signalling and potentially modify fibrotic disease processes.”

IPF is a progressive and life-threatening disease caused by scarring to the lungs and Boehringer Ingelheim is currently one of the major players in the market with its Ofev (nintedanib), with competition from Roche’s Esbriet (pirfenidone).

Last year Roche bought US biotech Promedior for $1.39bn, adding a potential IPF drug to its portfolio, and Belgium’s Galapagos has a potential IPF drug in phase 3 clinical development with Gilead with a readout due next year.

Porcupine inhibition is a novel anti-fibrotic approach that suppresses Wnt ligand secretion from pro-fibrotic cells.

Wnt ligands are known to be strong drivers of fibrotic mechanisms and are highly expressed in diseases such as IPF.

Wnt ligands regulate multiple aspects of disease biology so porcupine inhibition presents a potentially powerful anti-fibrotic approach.

 

The post Redx shares soar after IPF drug licence deal with AstraZeneca appeared first on .

Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe

Roche’s tumour-agnostic therapy Rozlytrek has been approved in the European Union for people with tumours with the NTRK mutation, meaning Bayer’s class rival faces competition in Europe for the first time.

Last September Bayer’s Vitrakvi became the first NTRK inhibitor class drug approved in Europe and the first ever drug licensed to tackle tumours solely based on their genetic signature, rather than their location in the body.

Following a positive opinion from the CHMP scientific committee in May, the European Commission granted a conditional marketing authorisation for Rozlytrek (entrectinib) for adults and children aged 12 years of age and older expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

To be eligible patients must have a disease that is locally advanced, metastatic, or face severe consequences following surgery.

They must also have not previously received therapy from an NTRK inhibitor.

The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

Roche noted that approval is based on results from the integrated analysis of the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and data from the phase 1/2 STARTRK-NG study.

However conditional approval means that the drug’s license is reviewed every year until confirmatory data from a larger trial.

Results so far showed Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours, producing an overall response rate (ORR) of 63.5% in a group of 74 patients.

Objective responses were observed across 14 tumour types and median duration of response was 12.9 months.

In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumours in 73.4% of people with the disease.

In a group of 161 patients with a minimum of six months follow up, including 29% of patients with central nervous system metastases at baseline, ORR was observed to be 67.1%.

Roche is developing a companion diagnostic in conjunction with Foundation Medicine to develop a companion diagnostic that will help identify people with NTRK and ROS1 gene fusions.

Rozlytrek was approved by the FDA in the NTRK indication in August last year, following on from a first approval in Japan in June last year.

Bayer’s Vitrakvi (larotrectinib) was approved in the US in for NTRK cancers in November 2018.

 

The post Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe appeared first on .

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots:

  • The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients
  • Result: in NTRK fusion+ solid tumors, ORR (63.5%); mDoR (12.9mos.); In ROS1+ advanced NSCLC, shrank tumors in 73.4% of patients; DoR of 16.5mos. (14.6-28.6mos.); ORR (67.1%); in patients with CNS metastases with an intracranial ORR (62.5% & 77.8%); In pediatric patients, Rozlytrek shrank tumors in all children and adolescents who had NTRK gene fusions with two achieving a CR
  • Rozlytrek (entrectinib, qd) is a tumor-agnostic treatment for LA/m-solid tumors harboring NTRK1/2/3 or ROS1 gene fusions and has received EMA’s PRIME designation to treat NTRK fusion-positive, LA/m- solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

 3. Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

4. Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

5. Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

6. Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

7.  Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

13.  Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

18.  Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

20.  Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

26. Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

27.   Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

29. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.