Ervaxx and Cardiff University Collaborate to Develop Novel T-cell and T-cell Receptor-based Immunotherapeutics Targeting Dark Antigens

Shots:

  • Cardiff University will receive milestone payments that advance from the discovery collaboration into clinical development and royalty payments on sales of any products that reach the market. Ervaxx will fund this program
  • Ervaxx gains an exclusive license to Cardiff University patents claiming T cells and TCRs reactive to cancer-specific antigens and has the right to advance resulting candidate T-cell/TCR-based immunotherapeutics and cancer vaccines
  • Ervaxx Dark Antigens derive from vast untapped expanses of genetic ‘dark matter’, which are generally silenced in normal tissue but can become selectively activated in cancer

Click here ­to­ read full press release/ article | Ref: PR Newswire | Image: Crick Institute

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Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots:

  • The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic SCAC who have progressed on or are intolerant of standard platinum-based CT
  • The study demonstrates 14% ORR for retifanlimab monotherapy as determined by ICR using RECIST v1.1 and mDOR of 9.5mos
  • Retifanlimab has received FDA’s ODD for the treatment of anal cancer along with PR which shortens the review period by 4mos vs Standard Review. The PDUFA target action date is Jul 25, 2020

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Technical.ly

The post Incyte Reports Acceptance and Priority Review of BLA for Retifanlimab to Treat Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) first appeared on PharmaShots.

Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Shots:

  • The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure
  • Covax includes an Advanced Market Commitment (AMC) financial mechanism under which Pfizer and BioNTech will provide access COVID-19 vaccines at a not-for-profit price in 92 countries
  • The Pfizer-BioNTech COVID-19 Vaccine has been authorized from EUA for active immunization to prevent COVID-19 in individuals 16 years of age and older

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

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Pfizer and BioNTech Signs an Agreement with Covax for Advance Purchase of Vaccine to Help Combat COVID-19

Shots:

  • The companies sign a purchase agreement with Covax to supply 40M doses of the COVID-19 vaccine. First deliveries are expected in Q1’ 2021, subject to the execution of supply agreements under the Covax Facility structure
  • Covax includes an Advanced Market Commitment (AMC) financial mechanism under which Pfizer and BioNTech will provide access COVID-19 vaccines at a not-for-profit price in 92 countries
  • The Pfizer-BioNTech COVID-19 Vaccine has been authorized from EUA for active immunization to prevent COVID-19 in individuals 16 years of age and older

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

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Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis

Shots:

  • The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to treat adult patients with LN
  • The study demonstrated significantly improved renal response rates vs SoC, improved response rates in all parameters across immunologically-active classes, 50 % reduction in UPCR twice as fast as SoC, complete renal response @24 wks vs SoC @1year
  • Lupkynis is the 1st FDA-approved oral therapy for LN and is now commercially available in the US

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Aurinia Pharmaceuticals

The post Aurinia Lupkynis (voclosporin) Receives US FDA’s Approval to Treat Adult Patients with Active Lupus Nephritis first appeared on PharmaShots.

P&G Signs a License Agreement with Rhinostics to Launch its Novel Nasal Swab into the Market for Rapid COVID-19 Testing and Address Supply Shortages

Shots:

  • Rhinostics plans to register the P&G polypropylene nasal swab as a Class I Exempt medical device and will pursue Emergency Use Authorization for home collection with rPT-PCR testing for detection of SARS-CoV-2 infection
  • Rhinostics Standard Nasal Swab is a polypropylene collection device developed in partnership with P&G for COVID-19 testing which provides sample concentration of up to 30-fold over other swabs in viral transport media
  • The swab increases COVID testing efficiencies being applicable to broader respiratory viral, bacterial, and genetic testing using the PCR and NGS

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Packaging Europe

The post P&G Signs a License Agreement with Rhinostics to Launch its Novel Nasal Swab into the Market for Rapid COVID-19 Testing and Address Supply Shortages first appeared on PharmaShots.

Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Shots:

  • The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously untreated advanced or metastatic RCC.
  • Results: @ median follow-up of 18.1 mos. patients treated with the combination achieved PFS of 16.6 mos vs 8.3 mos for Sutent arm. Opdivo + Cabometyx also significantly reduced the risk of death by 40% vs Sutent alone , ORR 56% in combination and 27% sunitinib
  • Application approved prior to PDUFA action date of Feb 20, 2021 and reviewed under the Real-Time Oncology Review pilot program

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

The post Exelixis Cabometyx (cabozantinib) + Opdivo (nivolumab) Receives US FDA’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma first appeared on PharmaShots.

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots:

  • The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ advanced NSCLC prior not treated with an ALK inhibitor
  • The therapy showed effectiveness in patients undergoing 1L & 2L treatment for ALK+ NSCLC including efficacy in patients with brain metastases.
  • Alunbrig is a potent and selective next-generation TKI designed to target ALK molecular alterations and is approved in 30+ countries including the US & EU

Click here ­to­ read full press release/ article | Ref: Takeda | Image: The Boston Globe

The post Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC first appeared on PharmaShots.

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Shots:

  • The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen
  • Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for ~1mos. to assess the tolerability of each therapy. The therapy reduces the treatment dosing days from 365 days to 12days/ yr
  • The company will begin shipping of Cabenuva to wholesalers and specialty distributors in the US in Feb’2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: ViiV Healthcare

The post ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment first appeared on PharmaShots.

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Shots:

  • The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the US for 0.5 mg and 1.0 mg doses to treat T2D in adults and to reduce the risk of MACE in adults with T2D mellitus and established CV disease

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

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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.

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots:

  • The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event
  • The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in annualized absolute risk. The 1EPs is time to the first event of CV death or hospitalization for HF @median follow-up of 11 mos.
  • Verquvo is the first soluble guanylate cyclase stimulator, approved to treat HF

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

The post Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure first appeared on PharmaShots.

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

Shots:

  • The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine
  • Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2+ BC prior treated with at least one dose of Enhertu (5.4 mg/kg) in clinical studies
  • Enhertu is a HER2 directed ADC and has received EMA’s CHMP accelerated assessment in Mar’20 for the same indication

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

The post Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer first appeared on PharmaShots.

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Shots:

  • The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021
  • The BLA filing marks the milestone on the path to commercialization of narsoplimab
  • Narsoplimab is an investigational mAb targeting MASP-2 has received the US FDA’s BTD and ODD to the FDA for each of HSCT-TMA and IgA nephropathy

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

The post Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA first appeared on PharmaShots.

Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots:

  • The PRIME designation is based on two Phase I/II studies in R/R cHL conducted at Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center
  • The studies showed the complete disappearance of tumors in ~60% of patients at the highest dose level with no serious toxicities, associated with several other CAR-T therapies. The results were published in Clinical Oncology
  • The company plans to commence a multi-center pivotal study in the US during 2021. Additionally, P-I clinical study for patients with r/r CD30 positive NHL is open for enrollment in the US

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

The post Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma first appeared on PharmaShots.

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Shots:

  • The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis
  • Genmab to receive $30M as milestones with the first commercial sale of Darzales faspro in this indication. The US FDA reviewed the submission of data for approval in this indication under RTOR pilot program and Project Orbis
  • Darzalex faspro is the SC formulation of daratumumab and is the only therapy for newly diagnosed Light-chain (AL) amyloidosis in the US

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

The post Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis first appeared on PharmaShots.

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Shots:

  • The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult patients with LA or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen
  • In a pre-specified interim analysis, it showed 41% reduction in the risk of death vs patients with mOS (12.5 vs 8.4mos); PFS (5.6 vs 3.5mos); ORR (40.5% vs 11.3%); CR (7.9% vs 0%); PR (32.5% vs 11.3%); DoR (11.3 vs 3.9mos.)
  • Enhertu is a HER2-directed ADC and has received the US FDA’s PR & BTD for HER2+ m-gastric cancer and ODD for gastric cancer

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

The post Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer first appeared on PharmaShots.

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Shots:

  • Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT
  • New option extends dosing from 2 to 4wks. thus, reducing medical visits and improving patient convenience. The approval is based on multiple clinical trials that include P-III PACIFIC study in NSCLS patients and P-III CASPIAN study in ES-SCLC patients
  • Durvalumab is a human mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80

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

The post AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK first appeared on PharmaShots.

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

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Medical, Marketing and Media

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

Shots:

  • Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma
  • The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab
  • The company has developed the HLX15 in accordance with the Technical Guidelines of Development and Evaluation of Biosimilar Drugs & EMA Guideline on Similar Biological Medicinal Products

Click here ­to­ read full press release/ article | Ref: Henlius | Image: BioSpectrum Asia

The post Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China first appeared on PharmaShots.

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

Shots:

  • The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment
  • The study showed 88% ORR. Among 23 patients, who achieved a response, 39% maintained their response for at least 6mos. and 22% maintained their response for at least 12mos.
  • Xalkori is a TKI and has received the FDA’s BTD for ALK+ ALCL in May’2018. Additionally, EMA has agreed to a PIP for the therapy to treat pediatric patients with r/r systemic ALK+ ALCL

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Bangkok Post

The post Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult first appeared on PharmaShots.

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

Shots:

  • The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC
  • The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified
  • Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The approval marks the third approval for tislelizumab in China and its first in a lung cancer indication

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Memorial Sloan Kettering Cancer Center

The post BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC first appeared on PharmaShots.

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

Shots:

  • The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age
  • The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. and weighing at least 14kg, bringing these in line with the WHO weight bands
  • Dolutegravir is the first integrase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4wks. and weighing at least 3kg.

Click here ­to­ read full press release/ article | Ref: VIIV Healthcare | Image: Smart Industry News

The post ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV first appeared on PharmaShots.

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D

Shots:

  • Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
  • The US FDA granted PR to the therapy, allowing the agency to take action on NDA within 6mos. of acceptance compared to 10mos. under standard review
  • Finerenone is an investigational, non-steroidal, selective MRA and has showed a reduction in harmful effects of MR overactivation. The therapy has demonstrated positive kidney and CV outcomes in patients with CKD and T2D

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

The post Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D first appeared on PharmaShots.

Lundback’s Vyepti (eptinezumab, IV) Receives Health Canada’s Approval for Preventive Treatment of Migraine

Shots:

  • The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2,076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos.
  • The studies met its 1EPs of decrease in mean monthly migraine days (MMD) over 1-12wks and showed 50% & 75% responder rates & good tolerability
  • Vyepti is a humanized mAb that binds to calcitonin gene-related peptide (CGRP)

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

The post Lundback’s Vyepti (eptinezumab, IV) Receives Health Canada’s Approval for Preventive Treatment of Migraine first appeared on PharmaShots.

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.

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

Shots:

  • The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
  • The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
  • In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

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

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

Shots:

  • The acceptance of regulatory submission and the granting of PR is based on P-III DAPA-CKD study assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ out T2D
  • The study demonstrated that the therapy reduced the risk of the composite of worsening of renal function or risk of CV or renal death by 39% and reduction in the risk of death from any cause by 31%. The safety & tolerability is consistent with the known safety profile of the therapy
  • Farxiga is an SGLT2 inhibitor and has received the US FDA’s BTD for CKD with/ out T2D. The anticipated PDUFA date for the therapy is Q2’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Nutralngredients-Asia

The post AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease first appeared on PharmaShots.

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

Shots:

  • The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA unresectable metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR
  • Result: improvement in ORR (37% vs 21%); reduction in the risk of disease worsening or death (42%); ORR (66% vs 24%); m-PFS (not reached vs 4.11 mos.); Grade 3 AEs (48% vs. 44%)
  • Tiragolumab is a mAb designed to bind with TIGIT and works as an immune amplifier, by potentially enhancing the body’s immune response. The company is evaluating the tiragolumab across various settings in different tumor types, including lung, esophageal and cervical cancers

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

The post Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer first appeared on PharmaShots.

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

Shots:

  • The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg, qw) vs Somatropin (0.034 mg/kg, qd) in 224 pediatric patients in the ratio of (1:1) with GHD
  • The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 cm/year); the treatment difference in height velocity was 0.33 cm/yr
  • The anticipated PDUFA date is Oct 2021 and is approved, the therapy is served as a once-weekly treatment option

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: The Wire

The post Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency first appeared on PharmaShots.

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

Shots:

  • The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021
  • The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
  • Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved, teplizumab will be the first disease-modifying therapy for T1D

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

The post Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D first appeared on PharmaShots.

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

Shots:

  • The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb
  • The P-II SADAL study involves assessing ATG-010 in patients with rrDLBCL, including DLBCL arising from FL, who have received at least 2 prior therapies. The studies demonstrated efficacy with a manageable safety profile for ATG-010
  • ATG-010 (Xpovio) is a first-in-class oral SINE and is the first FDA approved drug for use in both MM and DLBCL

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

The post Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea first appeared on PharmaShots.

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

Shots:

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

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

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

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

Shots:

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

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

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

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

Shots.

  • The company has submitted MAA to COFEPRIS (the health regulatory authority for Mexico) for its COVI-STIX rapid diagnostic test to detect SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients
  • The test provides results in 15min. with positive detection as quickly as 2min for patient samples with high viral load.
  • Additionally, Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD, COVI-AMG, COVI-SHIELD, Gene-MAb, COVI-MSC and COVI-DROPS and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRAC

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

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

Shots:

  • Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs.
  • With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is in H1’21
  • Trikafta is a triple combination regimen used to treat CF in patients aged ≥12yrs. who have at least one copy of the F508del mutation in the CFTR gene

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

The post Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis first appeared on PharmaShots.

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

Shots:

  • The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals
  • The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study
  • The trial has been reviewed by an independent DSMB & reports have been submitted to CDSCO regularly for the update on safety outcome

Click here ­to­ read full press release/ article | Ref: Zydus Cadila | Image: eHealth Magazine

The post Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D first appeared on PharmaShots.

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

Shots:

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

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

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

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

Shots:

  • The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg of dose achieved significant and superior reduction in HbA1c @40wks., both the doses are safe and well-tolerated
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the EU for 0.5 mg and 1.0 mg doses to treat T2D in adults

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

The post Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D first appeared on PharmaShots.

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

Shots:

  • Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21
  • The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic NET & pancreatic NET patients with an acceptable risk/benefit ratio
  • Surufatinib is an oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR. The US FDA has granted FTD to surufatinib for pancreatic and non-pancreatic NET in Apr’2020 and ODD for pancreatic NET in Nov’2019

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

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

Shots:

  • The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL
  • The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no existing treatment and evidence indicates the benefit of the therapy vs available treatment
  • CNCT19 targets CD19 is a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CNCT19 is currently being developed by Casi and Juventas Cell Therapy

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

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

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

Shots:

  • The US FDA has granted orphan drug designation for AP103 for the treatment of DEB
  • Amyrt licensed a pre-clinical gene – therapy platform technology to treat patients with DEB, a subset of EB also applicable for genetic disorders in Mar 2018
  • AP103 is based on a novel polymer-based topical delivery platform and offers potential advantages in the gene therapy field also used in other genetic skin conditions

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

The post Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB) first appeared on PharmaShots.

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

Shots:

  • The NMPA has approved Byvasda for the treatment of adult recurrent Glioblastoma which is the third approved indication of Byvasda in China
  • The launch of Byvasda has provided Chinese patients with high quality and relatively more affordable bevacizumab biosimilar injection
  • Byvasda is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Byvasda has been approved in China for the treatment of NSCLC and mCRC

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

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

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

Shots:

  • Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma
  • The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to be submitted and reviewed on an ongoing basis and the data were presented at the 62nd (ASH) Annual Meeting
  • Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and 2 BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion

Click here ­to­ read full press release/ article | Ref: Janssen  | Image: Apotheke Adhoc

The post Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma first appeared on PharmaShots.

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

Shots:

  • The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT)
  • Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in the risk of disease progression or death (53%)
  • Darzalex is the first CD38-directed mAb approved to treat multiple myeloma. The subcutaneous formulation was approved by Health Canada to treat patients with multiple myeloma in 2020

Click here ­to­ read full press release/ article | Ref: Newswire.CA  | Image: Philadelphia Inquirer

The post Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma first appeared on PharmaShots.

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

Shots:

  • The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine
  • The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose
  • The CMA is valid in all 27 member states of the EU while the companies are ready to immediately ship initial doses to all the member state

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

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

Shots:

  • The approval is based on data assessing bioequivalence and AEs associated with IM administration vs SC administration of Plegridy in healthy volunteers
  • Result: The data showed that participants receiving therapy through IM experienced fewer injection site reactions (14.4 vs 32.1 %), safety profiles were similar. The frequency of injection site reactions and AEs were comparable in participants who were dosed with IM followed by SC, compared to SC followed by IM
  • The approval expands the offerings to the individuals with RMS, providing treatment option combining safety & efficacy to optimize the treatment experience with a reduction in injection site reactions

Click here ­to­ read full press release/ article | Ref: Biogen  | Image: The New York Times

The post Biogen’s Plegridy (peginterferon beta-1a, IM) Receives EC’s Approval for Relapsing-Remitting MS first appeared on PharmaShots.

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

Shots:

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

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

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

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

Shots:

  • The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021
  • Allocation and distribution will be prioritized according to populations identified by the CDC’s ACIP. The Company expects to have b/w 100-125M doses available globally in the Q1’21, with 85-100M of those available in the US
  • The US govt. ordered total 200M doses to date & retains an option to purchase up to an additional 300M doses, ~20M doses will be delivered by the end of Dec 2020

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

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

Shots:

  • The approval is based on P-III ATLAS, FLAIR and ATLAS-2M studies assessing Vocabria (cabotegravir) + Janssen’s Rekambys (rilpivirine inj.) or Edurant (rilpivirine tablets) in 1200+ patients for HIV-1 infection in adults who are virologically suppressed
  • The first long-acting injectable can enable people living with HIV to reduce the days they receive treatment from 365 to 12 or 6/year. Most of the clinical trial patients who tried the treatment over their previous daily oral therapy preferred the new treatment
  • The approval marks the second approval of the long-acting regimen of cabotegravir and rilpivirine, with once-monthly dosing licensed by Health Canada under the brand name Cabenuva

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: The Pharma Letter

The post ViiV Healthcare’s First Long-Acting Injectable Receive EC’s Approval for the Treatment of HIV first appeared on PharmaShots.

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

Shots:

  • The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + SOC in 448 adult patients with active LN
  • The study met its 1EPs demonstrating a greater number of patients who achieved PERR @2yrs. (43% vs 32%., all 2EPs were achieved while safety results are consistent with the known safety profile of Benlysta
  • Benlysta is a mAb that binds to soluble BLyS and does not bind B cells directly. The approval extends the current indication in the US to include both SLE and LN for both the IV and SC formulations

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

The post GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN) first appeared on PharmaShots.

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

Shots:

  • The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs
  • The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy
  • The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval

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

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

Shots:

  • The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • The study demonstrated an OR rate (93 %) with CR (67%), as assessed by an Independent RRC following a single infusion. In safety analyses, Grade 3 or higher CRS and neurologic events in 15% and 33% of patients
  • Tecartus is the first CAR T therapy in r/r MCL. With the approval, Kite becomes the first company with multiple approved cell therapies in the EU

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

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

Shots:

  • The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
  • The study provided durable anticancer activity with a positive benefit-risk profile
  • The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible

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

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

Shots

  • The Health Canada has approved Zolgensma (onasemnogene abeparvovec) for pediatric patients with 5q SMA with bi-allelic mutations in the SMN1 gene and 3 or fewer copies of SMN2 gene or infantile-onset SMA
  • The efficacy and safety data supporting the approval of Zolgensma are derived from completed and ongoing studies in patients with SMA and 2 copies of SMN2 gene and presymptomatic genetically diagnosed SMA and 2 or 3 copies of SMN2 gene
  • Zolgensma (IV) is a gene therapy designed to address the genetic root cause of SMA by replacing the missing or defective SMN1 gene

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

The post Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA first appeared on PharmaShots.

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

Shots:

  • The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF
  • The decision was based on efficacy & safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF (P-III study in HFpEF) and additional evidence from PARAMOUNT (P-II trial in HFpEF), as well as PARADIGM-HF (P-III trial in HFrEF)
  • Entresto (sacubitril/valsartan) is a prescription medicine used to reduce the risk of CV death & heart failure hospitalization in people with long-lasting heart failure

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

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

Shots:

  • The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs.
  • The data submitted to the US FDA from an independently run, simulated home-setting clinical study of 198 subjects aged 2-82yrs, demonstrated 96% accuracy including 95% overall sensitivity & 97% specificity vs emergency use-authorized RT-PCR lab test
  • The test’s core technology combines ultra-sensitive optics, electronic software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology

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

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

Shots:

  • OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone
  • An initial study showed that just one 30min treatment with OsteoBoost reduced bone loss activity in all participants, showing a decrease of 14%, a reduction on par with bisphosphonate drugs
  • The NIH funded a $2M to study for determining the positive effects of OsteoBoost in a larger study with a broader population. The larger study is currently enrolling patients & is scheduled to be completed in early 2022

Click here ­to­ read full press release/ article | Ref: Bone Health Tech | Image: Linkedin

The post Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis first appeared on PharmaShots.

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

Shots:

  • The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia
  • The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety and efficacy of TAK-721 in adolescent and adult patients (11-55 yrs. of age) with EoE
  • TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide and has earlier received the US FDA’s BT and ODD

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

The post Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis first appeared on PharmaShots.

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

Shots:

  • 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

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

The post Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp first appeared on PharmaShots.

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

Shots:

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

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

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

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

Shots:

  • The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. time
  • Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication
  • Ocrevus is a humanized mAb designed to target CD20-positive B cells and is the first and only therapy approved for both RMS and PPMS

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

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

Shots:

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

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

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

Shots:

  • The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval
  • The study showed a reduction in rate of mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA for Trixeo Aerosphere in Oct’2020
  • Trixeo Aerosphere is a single-inhaler, fixed-dose triple-combination of formoterol fumarate LABA, LAMA, with budesonide, an ICS, and delivered in a pressurized metered-dose inhaler. The approval marks the fourth major approval of the therapy

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Global Justice Now

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

Shots:

  • Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021
  • The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 infection & also in participants with/ out prior infection
  • In Jul 2020, the companies collaborated with the HHS & DoD to meet the Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19

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

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Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Shots:

  • The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment
  • The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline as measured by MMSE, ADAS-Cog 13 & ADCS-ADL-MCI. MHLW will review the application through the standard review process
  • Aducanumab is an investigational mAb that is under the US FDA’s PR with an anticipated PDUFA date as Mar 7, 2021 and is also under review with the EMA

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Barron’s

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Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Shots:

  • Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the NACI
  • BioNTech will hold the regulatory approval in Canada while Pfizer will have the commercialization rights. The approval is based on data that was filed through the rolling submission regulatory pathway and data from the P-l/ll clinical trial that began recruiting in Jul’2020 & enrolled ~44,000 patients across ~150 sites in multiple countries
  • The companies will supply ~20M doses of vaccine to Canada through 2021

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

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Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Shots:

  • The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy
  • The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen has several P-Ib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment
  • Sotorasib has also accepted into FDA’s Real-Time Oncology Review Pilot Program. Additionally, the company plans to submit the NDA to the US FDA by the end of 2020

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

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

Shots:

  • Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes
  • The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning
  • The technology sustains performance for ~14days, providing trends, insights & actionable data on a reader or with the FreeStyle LibreLink mobile app. FreeStyle Libre 2 will be available for people with diabetes aged ≥4yrs. in Canada in the coming months

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

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Jakarta Post

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

Shots:

  • The approval is based on P-I/II ARROW study involve 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

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

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

Shots:

  • The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020
  • The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability with no safety concerns
  • In addition to submission to EMA, FDA & MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies globally

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Stat

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

Shots:

  • 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

Source1, Source2 ­to­ read full press release/ article | Ref: Genentech & Novartis | Image: Dr. Thomas Chacko

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

Shots:

  • The EC’s approval is based on a P-III study assessing Dupixent (300mg, q4w & 200mg, q2w) + TCS vas TCS alone in children aged 6-11yrs. with severe AD
  • Result: improvement in disease extent and severity (82% & 80% vs 49% & 48%); at least 75% improvement (70% & 75% vs 17% & 26%); skin clearance (33% & 39% vs 11% & 10%); reduction in itching (51% & 61% vs 12% & 13%); improvement in HR-QoL (77% & 81% vs 39% & 36%) respectively
  • Dupixent is mAb that inhibits the signaling of IL-4 and IL-13 proteins and is the only systemic medicine approved in the EU to treat children with severe AD

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

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

Shots:

  • The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety concerns identified to date
  • Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
  • The FDA has told Company to expect VRBPAC meeting for mRNA-1273 on Dec 17, 2020. The Company will submit data from the P-III COVE study to a peer-reviewed publication

Click here ­to­ read full press release/ article | Ref: Moderna | Image: Fox Business

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

Shots:

  • The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D
  • The study demonstrated reduced the risk of the composite outcome by 26% along with a reduction in the risk of CV death or worsening of HF events, including hospitalization for HF
  • Additionally, Forxiga is currently being tested for HFpEF in the P-III DELIVER trial with data readout anticipated in the H2’21

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

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

Shots:

  • The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment
  • Result: The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target PGAR @26wks. of administration (54.5%)
  • The indication marks Humira’s 12th indication in Japan and making it the world’s first drug indicated for the treatment of PG. Humira has received MHLW’s ODD for the treatment of PG in 2019

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

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

Shots:

  • The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test
  • Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no new safety signals identified
  • Xofluza inhibits the cap-dependent endonuclease in the PA protein and is a single-dose oral treatment for influenza which is different from all other currently available antiviral treatments

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

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

Shots:

  • Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies
  • Egle has leveraged its unique bioinformatic & translational capabilities to identify targets
  • Following the achievement of the target identification, Egle will receive an R&D milestone payment & equity funding from Takeda

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

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

Shots:

  • The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy
  • With the validation, the application is complete, and the EMA will now initiate the review procedure.
  • Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET alteration. The FDA is reviewing the application under PR and through the Real-Time Oncology Review pilot program

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

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

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: y-mAbs

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

Shots:

  • The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC &
  • Who were biologic-naïve only and had an inadequate response to SOC respectively
  • Combined results: achieved 1EPs of ACR20 @24wks.; improvements in quality of life scores; improvement in PASI 75, PASI 90, and PASI 100 rates. In DISCOVER-2 study, @24wks. less radiographic progression in both groups Tremfya is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and PsO

Click here ­to­ read full press release/ article | Ref: Janssen | Image: The Pharma Letter

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

Shots:

  • 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

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

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

Shots:

  • The approval is based on P-lll ATTRACTION-3 study involve the assessment of Opdivo vs CT (docetaxel or paclitaxel) for patients with esophageal cancer refractory/ intolerant to 1L combination therapy with fluoropyrimidine- and Pt.-based drugs
  • Results: reduction in risk of death (23%); m-OS (10.9 vs 8.4 mos.); @12 & 18-mos. OS rates (47% & 31% vs 34% & 21%); ORR (19% and 22%); DoR (6.9 vs 3.9 mos.)
  • Opdivo is a PD-1 immune checkpoint inhibitor, designed to harness the body’s immune system to help restore anti-tumor immune response and is the first immunotherapy to be approved for gastroesophageal cancer in the EU

Click here ­to­ read full press release/ article | Ref: Bristol Myers Squibb | Image: Bristol Myers Squibb

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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

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

Shots:

  • 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

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

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

Shots:

  • The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting
  • Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are similar
  • Health Canada authorized the therapy for the use of bamlanivimab (LY-CoV555) as a treatment for adults & pediatric patients aged≥12yrs. with mild to mod. COVID-19 who weigh at least 40 kg & are at high risk of progressing to severe COVID-19 illness or hospitalization

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

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

Shots:

  • The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT and prior treated advanced bladder cancer
  • The approval is based on multiple studies, including the P-III PACIFIC study which supported the 2wks., wt. based dosing in unresectable stage III NSCLC, and the P-III CASPIAN study which used 4wks. FD, during maintenance treatment in ES-SCLC
  • The new dosing option for Imfinzi is under regulatory review in multiple countries, including in the EU where the new dosing option was granted accelerated assessment

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

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

Shots:

  • In terms of the agreement, lilly will commercialize the system, which is currently in development & will include an insulin pump developed & manufactured by ypsomed
  • Ypsomed’s insulin pump has been marketed in europe since 2016, available in 21 countries as the mylife ypsopump. Lilly will commercialize a version of this insulin pump, along with CGM & automated insulin delivery technology, in the US & europe also this pump will use pre-filled insulin cartridges for Lilly’s rapid-acting insulins
  • Ypsomed plans to submit a version of the mylife ypsopump for clearance to the US FDA for use in automated insulin delivery in 2022, if cleared, lilly will have exclusive rights to commercialize the pump in the US

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

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

Shots:

  • The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements
  • Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 (4.7% vs 7.1%) with a relative reduction of 35%; better clinical status @day15
  • This marks the second Lilly therapy to be granted a EUA, in addition to neutralizing Ab EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: CNBC

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

Shots:

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

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

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

Shots:

  • The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU
  • The P-III efficacy study demonstrated improved protection against influenza compared to standard-dose influenza vaccine and reduced the risk of influenza by an additional 30% in adults aged ≥50yrs.
  • Supemtek contains three times more antigen than both egg-based and cell-based standard-dose vaccines. Supemtek is also approved in the US under the tradename Flublok Quadrivalent

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

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

Shots:

  • EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI
  • In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, EU, Japan, and Australia
  • Ranibizumab is an anti-VEGF therapy for retinal vascular disorders, which is a leading cause of blindness in the US

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

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

Shots:

  • Deep Genomics will receive an undisclosed upfront payment and is eligible to receive development milestones, BioMarin will receive an exclusive option to obtain Deep Genomics’ rights to each program for development & commercialization
  • Deep Genomics will use its AI drug discovery platform (The AI workbench) to identify & validate target mechanisms, lead candidates & BioMarin will advance them into preclinical & clinical development
  • AI workbench enables rapid exploration of novel targetable mechanisms & therapeutic candidates, it combines deep learning, automation, advanced biomedical knowledge & massive amounts of in vitro & in vivo data to accurately identify targetable molecular mechanisms & guide the discovery & development of oligonucleotide therapies

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

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

Shots:

  • The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021
  • The BLA is based on positive data from two trials: P-III COMET study and P-II mini-COMET study and the results from both the studies were presented at World Muscle Society and the American Association of Neuromuscular & Electrodiagnostic Medicine and WORLDSymposium respectively
  • Avalglucosidase alfa is an investigational enzyme replacement therapy designed to improve the delivery of GAA enzyme to muscle cells, and it would become a potential new SoC for patients with Pompe disease (if approved)

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

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

Shots:

  • This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020)
  • Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets. The HIV incidence rate is 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group
  • A partner HIV prevention study (HPTN 084) in sub-Saharan African women was stopped earlier this month based upon recommendation of the independent DSMB following the superioriority of cabotegravir to oral FTC/TDF tablets. The company plans to use the data from both the HPTN studies for future regulatory submissions

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

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

Shots:

  • The approval is based on a study supporting its safety, efficacy in dogs with a measurable cutaneous/ SC MCT on the lower leg and follows the EMA’s MAA granted in early 2020
  • Stelfonta provides 75% complete tumor resolution after just one injection, and dogs quickly regain pre-treatment QoL. The therapy will be launched in the US in the coming months and then made available to primary care veterinarians from early 2021
  • QBiotics is currently investigating Stelfonta in a series of human P-I & P-II clinical trials targeting solid tumors as both as monothx. and an immune checkpoint inhibitor combination therapy

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

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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

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

Shots:

  • The approval extends the use of Fycompa as adjunctive therapy for POS (with/out secondary generalization) by expanding the approved age range from 12yrs.+ to 4yrs.+ and for PGTCS from 12yrs.+ to 7yrs.+
  • The approval is based on P-III 311 study assessing Fycompa (oral suspension) as adjunctive therapy in 180 pediatric patients (aged 4-12 yrs.) with POS or PGTCS
  • The 232 study involves assessing the PK, efficacy, and long-term safety of Fycompa taken at the same time as other AEDs therapy in 63 pediatric patients with epilepsy in patients aged 2 to >12yrs. Fycompa is an AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures

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

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NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Shots:

  • The US FDA has permitted marketing of a device intended for the temporary reduction of sleep disturbance related to nightmares in patients aged ≥22 yrs. suffering from nightmare disorder or PTSD
  • Nightware utilizes Apple Watch and an iPhone that is configured and logged into a software application and the Nightware server and monitors the wearer’s HR and movement while they sleep and if they are having a nightmare, gently arouse them out of the dream without waking up completely, using the smartwatch’s vibrations
  • The platform received the US FDA’s BT designation in May’2019 and now is available by prescription only and is intended for home use

Click here ­to­ read full press release/ article | Ref: FDA | Image: IT PRO

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Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Shots:

  • The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC vs PBO in ~5,700 patients with CKD and T2D
  • Result: reduction in the combined risk of time to kidney failure; a decrease of eGFR (≥ 40%) from baseline @4wks. or renal death by 18%, reduction in risk of 2EPs i.e. time to CV death, non-fatal MI, non-fatal stroke, or hospitalization for HF by 14% over a median duration of follow-up of 2.6yrs.
  • Finerenone is a selective MRA, being evaluated in FIGARO-DKD study in ~7,400 patients with CKD and T2D. Bayer has also initiated P-III FINEARTS-HF study of finerenone in symptomatic HF patients with a left ventricular ejection fraction of ≥40%

Click here ­to­ read full press release/ article | Ref: Bayer | Image: The Business Journals

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The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Shots:

  • The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab
  • The committee voted 5-0 and 6 uncertain on showing PD effect of aducanumab on AD pathophysiology. Finally, the committee voted 0-10 & 1 for exploratory analyses of Study 301 & 302, along with study 103 and evidence of a PD effect on AD pathophysiology
  • Following the committee’s opinion, the US FDA is expected to make a decision on approval of aducanumab’s BLA by Mar 7, 2021

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

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AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Shots:

  • The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days
  • Results demonstrated a reduction in the rate of the composite 1EP of stroke & death by 17%, risk of severe bleeding events (0.5% vs 0.1%). Regulatory submissions to expand the approved indication are under regulatory review in China and the EU
  • Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. The approval follows the US FDA’s PR designation granted in Jul’2020

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

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

Shots:

  • The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
  • Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
  • Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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

Shots:

  • The approval is based on P-III DAPA-HF study involves assessing of Forxiga (10mg) + SOC vs PBO +SOC in 4744 patients with heart failure and reduced ejection fraction (LVEF ≤ 40%) with/out T2D
  • Results: reduction in risk of the composite outcome by 26%, with both components of the 1EPs (first occurrence of a worsening HF event or CV death) contributed benefit to the overall effect.
  • Forxiga is the first SGLT2 inhibitor approved in the EU for HFrEF in adult patients with/out T2D. The therapy is currently being evaluated for HFpEF in P-III DELIVER study with its anticipated results in H2’21

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Health Quest Patient Center

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

Shots:

  • The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application
  • Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in ~70 infants and young children with achondroplasia, aged 0-<60mos., for 52wks.
  • Vosoritide (qd) is an investigational injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received the US FDA’s & EMA’s ODD for the same

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

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

Shots:

  • CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 M, including $69.5M previously announced have funded preclinical studies and P-l study, preparations for the global pivotal P-ll/lll efficacy study, and initial manufacturing scale-up activities
  • The expanded collaboration will provide $258.5M for a global pivotal P-ll/lll efficacy clinical trial which is expected to begin before the end of 2020 and generates the safety and efficacy data to support licensure of the vaccine candidate in China and across the globe
  • The collaboration anticipates that the vaccine will be made available for procurement and allocation through the COVAX Facility, which aims to fairly distribute 2B doses of COVID-19 vaccine by the end of 2021

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Los Angeles Times

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

Shots:

  • The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (atezolizumab, 1200mg) + Avastin (bevacizumab, 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
  • Result: reduction in the risk of OS (42%); reduction in the risk of disease worsening or death, PFS (41%); showed improvement in both OS and PFS; Grade 3–4 AEs (57% vs 55%), published in the NEJM
  • The approval follows an EMA’s CHMP positive opinion received in Sept’2020. The dual regimen also recently included as a class I, A recommendation by the ESMO for unresectable HCC, as well as by many clinical practice guidelines globally

Click here to­ read the full press release/ article | Ref: Roche | Image: National Foundation For Cancer Research

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

Shots:

  • The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of PP1M or PP3M across 20 countries
  • Results demonstrated non-inferior efficacy of PP6M to PP3M on the 1EPs of time to relapse at the end of the 12mos. period in both intent-to-treat and per-protocol analysis sets, the safety profile is consistent with no new safety signals
  • If approved, PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen. Additionally, Janssen plans to submit an MAA extension to the EMA for PP6M in the coming months

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

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FTC clears Mylan merger with Pfizer’s Upjohn – with conditions

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products.

The Federal Trade Commission (FTC) has ruled that the combined company – to be called Viatris – could have an anticompetitive position in the US market for seven generic drugs used for high blood pressure, heart failure, epilepsy, bacterial infections and uterine bleeding if the divestments don’t go ahead.

The FTC’s ruling means that Pfizer and Mylan have now obtained all the antitrust approvals needed for the merger to go ahead. Upjohn is now due to be spun off from Pfizer on 13 November, with the merger concluding three days later – around 16 months after first being announced. It was backed by the European Commission in mid-September.

Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word. Mylan shareholders will hold approximately 43% of the new venture, with Pfizer investors taking 57%.

The deal is structured in a similar way to Pfizer’s joint venture with GlaxoSmithKline in consumer health, allowing the company to shed off lower-margin products whilst retaining an interest and generating cashflow to invest in its new product pipeline.

Mylan meanwhile will benefit from Upjohn’s greater global reach, allowing its generics to grow more quickly, according to the companies.

The generics that have to be divested include medroxyprogesterone, amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin, and eplerenone products, according to the FTC.

Upjohn’s amlodipine besylate/atorvastatin, phenytoin, prazosin, spironolactone, gatifloxacin and medroxyprogesterone products must be divested to Prasco, and Mylan’s eplerenone product must also be shed.

The FTC was also concerned about three other drugs – sucralfate to treat and prevent ulcers in the small intestines, levothyroxine for hypothyroidism, and varenicline, the active ingredient in Pfizer’s smoking cessation brand Chantix.

The approval conditions also require a green light from the FTC before Pfizer, Mylan or Viatris may “gain an interest in, or exercise control over, any third party’s rights” to levothyroxine, sucralfate and varenicline tablets.

The divested products should continue to be manufactured by Upjohn and Mylan’s current suppliers in order to avoid any shortages in the market, and in some cases Pfizer will act as a contract manufacturer to Prasco.

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

Shots:

  • Medtronic has expanded its portfolio of technologies focusing on improving the safety of head and neck surgeries with the acquisition of Ai Biomed and the US FDA’s 510(k) clearance of NIM Vital nerve monitoring system
  • The NIM Vital nerve monitoring system enables physicians to identify, confirm, and monitor nerve function to help reduce the risk of nerve damage during head and neck surgery
  • The acquisition marks the 7th acquisition by Medtronic in 2020. The acquisition will add the PTeye laser system to Medtronic’s ENT portfolio which a tissue-detecting probe used in thyroid surgery

Click here to­ read the full press release/ article | Ref: Medtronic | Image: Market Watch

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AstraZenca Expands Supply Agreement with Cheplapharm for Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil + hydrochlorothiazide) to Cheplapharm

Shots:

  • Cheplapharm to pay AstraZeneca a total of $400M non-contingent consideration, present value recognised as other operating income upon completion of the transaction, anticipated during the Q4’2020. $250M (of the $400M consideration) will be payable on completion and the remainder in H1’2021
  • AstraZeneca has agreed to sell the commercial rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil + hydrochlorothiazide) in around 70 countries globally to Cheplapharm
  • Atacand is a selective, AT1 subtype angiotensin II receptor antagonist that is indicated for the management of hypertension in adults and children/adolescents, as well as HF in adults

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

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GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots:

  • The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
  • Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
  • Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Spiegel

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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

Shots:

  • 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

Click here to­ read the full press release/ article | Ref: Sanofi | Image: The Healthcare Technology Report

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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

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AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

Shots:

  • The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries
  • The study demonstrated that Forxiga achieved a significant reduction in the composite EP of hHF or CV death. The trial confirmed the well-established safety profile of Forxiga
  • The NMPA’s label update follows the update to the EU MAA in Aug’2019 and the US FDA’s approval granted in Oct’2019

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

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Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

Shots:

  • The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies
  • The FoundationOne CDx is the tissue-based CGP test approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with Vitrakvi
  • The approval of Vitrakvi was based on three studies including LOXO-TRK-14001,  SCOUT, and NAVIGATE studies and is indicated for the treatment of adult and pediatric patients with solid tumors that have NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Clinical OMICs

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

Shots:

  • The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types
  • The focus of the study is to determine the maximum tolerated dose and recommended dose of DS-1055 for further study and is expected to enroll ~40 patients across the US and Japan. The company will integrate novel technologies with expertise in Ab biology to develop clinical candidates
  • DS-1055 is a mAb designed to target GARP and to promote antitumor immunity through the depletion of GARP positive Tregs

Click here ­to­ read full press release/ article | Ref: Daiichi Sankyo | Image: Medical Dialogues

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

Shots:

  • The EMA’s CHMP has adopted a positive opinion on a license extension for Vimpat (lacosamide) and Lacosamide UCB (lacosamide) as an adjunctive therapy in the treatment for PGTCS in adults, adolescents, and children from 4 years of age with idiopathic generalized epilepsy
  • The CHMP’s positive opinion is based on P-lll study assessing lacosamide as an adjunctive treatment for uncontrolled PGTCS. The therapy lowered the risk of developing a second PGTCS during a 24wks. period and demonstrated a higher rate of freedom from PGTCS during the treatment period
  • The company expects the EC’s formal approval decision before the end of 2020, that broaden the clinical application of Vimpat and make a new treatment option available to aid the management of PGTCS

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

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

Shots:

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the first and only approved COVID-19 treatment in the United States.

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Los Angeles Times

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

Shots:

  • The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients
  • Novartis expects to initiate the P-IIb study for branaplam in HD patients in 2021
  • Branaplam (qw, PO) is an RNA splicing modulator, currently under investigation for the treatment of SMA

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

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

Shots:

  • The approval is based on P-lll COAST-X study assessing Taltz (80mg, q4w) vs PBO for the treatment of adult patients with nr-axSpA with objective signs of inflammation for 52wks.
  • Result: 1EPs of ASAS40 @16wks. (35% vs 19%); ASAS40 [email protected] (30% vs 13%), met its 2EPs, showing efficacy in reducing disease activity and sacroiliac joint inflammation, improving patient function & QoL, the safety profile is consistent with the previous study
  • Taltz is a mAb that selectively binds with IL-17A cytokine and inhibits its interaction with the IL-17 receptor

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Everyday Health

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

Shots:

  • AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
  • The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

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

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

Shots:

  • The company submitted applications to the US FDA & EMA seeking approval for Rinvoq (upadacitinib) for adults (15mg/30mg, qd) and adolescents (15mg, qd) with moderate to severe AD. The submission is based on three pivotal P-III studies and was studied without TCS in Measure Up 1 and Measure Up 2 and with TCS in AD Up
  • Results: Rinvoq demonstrated an improvement in skin clearance and reduction in itch in adults and adolescents, met its co-1EPs including at least a 75% improvement in EASI 75 and a validated (vIGA-AD) score of 0/1 @16wks., no new safety profile in observed
  • Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. The submissions reinforce AbbVie’s commitment to bringing Rinvoq to more patients living with immune-mediated diseases

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: The Wall Street Journal

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

Shots:

  • The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM
  • The study demonstrated that the combination regimen demonstrated a reduction in risk of disease progression or death in adults by 40%, mPFS (11.5 vs 6.5), well-tolerated with no increase in treatment discontinuation
  • Isatuximab is a mAb that binds to a specific site on CD38 and is now available to eligible patients through the NHS Cancer Drugs Fund. Isatuximab is the first mAb approved in EU to be used in combination with pom-dex for RRMM

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

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

Shots:

  • The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively
  • Combined results: @24wks. improvement in ACR (20%); improvements in quality of life scores SF36; higher PASI 75, PASI 90, and PASI 100 response rate were observed. In both studies, Tremfya was generally well tolerated through study completion
  • Guselkumab is the first approved mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. If approved, guselkumab will be the first selective (IL)-23 p19 subunit inhibitor licensed for both PsA and moderate to severe PsO

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

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

Shots:

  • The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials
  • P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi Aerosphere over 52wks. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators
  • Trixeo Aerosphere is a single-inhaler, fixed-dose triple combination of formoterol fumarate, glycopyrronium bromide with budesonide, delivered in a pressurized metered-dose inhaler, and is approved under the brand name Breztri Aerosphere in Japan, China & the US for COPD

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: TeleTrader.com

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

Shots:

  • The approval is based on P-lll VIALE-A & VIALE-C studies and updated data from the P-Ib M14-358 and the P-I/II M14-387 studies. The P-III studies involve assessing of Venclexta (400mg & 600mg, qd) + azacitidine & LDAC vs PBO + azacitidine & LDAC in 431 & 211 people with previously untreated AML who are ineligible for intensive CT respectively
  • VIALE-A results: Reduction in the risk of death (34%), m-OS (14.7 vs 9.6mos.), CR rate (37% vs 18%); CR+CRh rate (65% vs 23%), median duration (7.6 mos.). VIALE-C results: CR rate (27% vs 7.4%); DOCR (11.1mos. vs 8.3mos.); m-OS (7.2mos. vs 4.1mos.). In 2018, the US FDA has granted accelerated approval for AML
  • This is the second time that Venclexta has been reviewed under the FDA’s new RTOR and Assessment Aid pilot program. Additionally, the FDA has granted five BTD for Venclexta, two of which are for people with previously untreated AML ineligible for intensive CT

Source 1, Source 2 ­to­ read full press release/ article | Ref: Abbvie & Roche | Image: Leukemia & Lymphoma Society

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

Shots:

  • The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr, after an initial dose and one @3mos., in adults with ASCVD, ASCVD risk equivalent or HeFH6
  • 80% of high-risk patients do not reach guideline-recommended LDC-L, targets despite the widespread use of statins. Reduction in LDL-C was achieved through 17mos. with a safety and tolerability profile like PBO
  • Additional post hoc analysis demonstrated 88% of them reached guideline-recommended targets at any timepoint during the study. Additionally, the therapy is also under review by the US FDA and other health authorities for primary hyperlipidemia in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Easy Health Options

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Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Shots:

  • Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
  • Luxturna is designed to provide functioning copies of the RPE65 gene to act in place of mutated RPE65 genes. The functioning genes work to restore vision and improve sight, giving patients the potential for greater independence
  • Novartis has entered a partnership with Blueprint Genetics to facilitate the genetic testing where appropriate to validate the diagnosis

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

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Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Shots:

  • The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3
  • FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with type 2 or 3 SMA
  • Risdiplam (PO) is a therapy designed to increase and sustain SMN protein levels in the CNS & throughout the body. The therapy has received MHLW’s ODD on Mar 27, 2020, and is a subject to PR in Japan

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

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Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots:

  • The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL after at least one multi-agent CT regimen
  • Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 3mos); ORR (66% vs 54%); DOR (20.7 mos. vs 13.8mos.). The approval is reviewed under the FDA’s Project Orbis
  • Ketruda is a humanized mAb that blocks the interaction between PD-1 and its ligands, PD-L1 & PD-L2 thus activating T lymphocytes that affect tumor cells & healthy cells. Additionally, the US FDA has approved an updated pediatric indication for refractory cHL or cHL that has relapsed after two or more lines of therapy

Click here ­to­ read full press release/ article | Ref: Business Wire | Image: Fortune

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Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Shots:

  • The P-II study will evaluate STI-5656 in ~400 patients hospitalized due to COVID-19 having mild, moderate, and severe symptoms. The P-II clinical trials of abivertinib now cleared to proceed in both Brazil and the US
  • The dose to be tested is the same as in the US P-II trial but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of 7 days (versus 14 days for more advanced patients in the US)
  • Both the studies are complementary and address both dose duration and disease stage

    Click here to­ read the full press release/ article | Ref: Sorrento Image: Newsmax

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Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots:

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA.
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

    Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Stat

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

Shots:

  • 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

    Click here ­to­ read full press release/ article | Ref: Eyewire | Image: Times Union

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Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure

Shots:

  • The P-lll GALACTIC-HF study involves the assessing of Omecamtiv mecarbil (25mg, bid with the maintenance dose of 50 mg, 37.5mg, or 25mg, bid) vs PBO in 8,256 patients with HFrEF
  • Result: The study met its 1EPs of reduction in CV death or HF events (HF hospitalization and other urgent treatment for HF) while the study did not meet its 2EPs of reduction in time to CV death, presented at AHA 2020
  • Omecamtiv mecarbil is a cardiac myosin activator, targeting the contractile mechanisms of the heart, being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

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

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

Shots:

  • 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

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

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BMS’ Zeposia (ozanimod) Receives Health Canada Approval for Relapsing Remitting Multiple Sclerosis

Shots:

  • The approval is based on P-lll SUNBEAM & RADIANCE part B study which involves the assessing of Zeposia (0.92mg and 0.46 mg) vs Avonex (qw, IM) in 1,346 & 1313 patients with RMS for 12 & 24mos. across 158 & 150 sites in 20 & 21 countries respectively
  • Result: relative reduction in ARR (48% & 38%); absolute ARR (0.18 vs 0.35 & 0.17 vs 0.28). reduction in number of T1– weighted GdE (0.16 vs 0.43 & 0.18 vs 0.37); reduction in enlarging T2 brain lesions (1.47 vs 2.84 & 1.84 vs 3.18) respectively
  • Zeposia is the only first line S1P receptor modulator approved in Canada for the treatment of RRMS, acts by decreasing the frequency of clinical exacerbations

    Click here ­to­ read full press release/ article | Ref: News Wire Canada | Image: ME Support

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Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging

Shots:  

  • The company reports NDA submission and request for PR to the US FDA for hyperpolarised 129Xenon gas used to evaluate the pulmonary function and to visualize the lung using MRI. The NDA submission follows the completion of two P-III studies, demonstrating the effective measurement of regional lung ventilation
  • Both the studies met their 1EPs showing pre-defined equivalence of hyperpolarised 129Xenon MRI vs 133Xenon Scintigraphy and displayed a benign safety profile
  • 129Xenon gas MRI was used to measure regional pulmonary function in patients with lung diseases who were being evaluated for possible lung resection/ transplant surgery and is administered as an inhaled gas that is given to patients in a 10sec breath-hold MRI procedure

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

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Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment

Shots:

  • Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients
  • The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral [email protected] meeting its 1EPs, reduction in symptoms and COVID-related hospitalization and ER visits
  • Based on the combination regimen data, along with the previous findings for LY-CoV555, Lilly has submitted the initial EUA for LY-CoV555 monothx. and plans to initiate a large open-label pragmatic study in COVID-19 outpatients in Oct’2020. Additionally, Lilly anticipates the data supporting BLA submission for dual regimen as early as Q2’21

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: GMP News

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Exact Sciences and Pfizer Announce Extension and Amendment of their Cologuard Promotion Agreement

Shots:

  • Pfizer will continue to provide sales and marketing support and health system support for Cologuard through the end of 2022 and 2021, respectively. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth in the agreement
  • Cologuard was approved by US FDA in August 2014 and is included in American Cancer Society’s (2018) colorectal cancer screening guidelines. It is indicated to screen adults (aged 45 yrs. and older) who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool
  • Cologuard is the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. It is an accurate, at-home colon cancer screening option and is uniquely positioned to support screening during this time and after the pandemic abates

Click here to­ read full press release/ article | Ref: PR Newswire | Image: WMTV

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GSK Signs an Agreement with Vir Biotechnology to Develop Solutions for Coronaviruses

Shots:

  • GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act
  • The collaboration will focus on development of specific antibody candidates identified by Vir’s platforms (VIR-7831 and VIR-7832) which demonstrated high affinity for SARS-CoV-2 spike protein and highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. The companies plan to proceed directly into P-II clinical trial within next 3 to 5 mos.
  • Vir’s antibody platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, SARS-CoV-2, malaria, and others

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

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BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

  • The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
  • BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
  • BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London

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GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Shots:

  • The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status
  • The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1L Pt.-based CT
  • Zejula (PO, qc) is a poly (ADP-ribose) polymerase (PARP) inhibitor and has received approval in 2019, in Canada for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer

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

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AstraZeneca’s Farxiga Receives the US FDA’s Breakthrough Therapy Designation for Chronic Kidney Disease

Shots:

  • The BT destination follows P-lll DAPA-CKD assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, with/ out T2D across 21 countries
  • Results: 39% reduction in the composite measure of worsening of renal function or risk of CV or renal death; 31% reduction in death from any cause
  • Farxiga (PO, qd) is an SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monothx. and combination therapy as an adjunct to diet and exercise to improve glycemic control, weight loss, and BP reduction

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

Related News: AstraZeneca Reports Results of Farxiga (dapagliflozin) in P-III DAPA-CKD Trial for Patients With and Without Type-2 Diabetes

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Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Shots:  

  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

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

The post Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension first appeared on PharmaShots.

Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Shots:

  • The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020
  • The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis
  • TSHA-101 is an AAV9-based gene therapy, currently under development for rare, neurodegenerative disease that causes a progressive dysfunction of the CNS

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

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Shots:

  • The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China
  • In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s PR in Jul’2020
  • Vericiguat (BAY 1021189/ MK-1242) is an sGC-stimulator being developed to treat patients with symptomatic CHF with an ejection fraction less than 45% who have had a previous worsening HF event in combination with available HF therapies

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

Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Shots:

  • The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in fibrosis, inflammation, tissue remodeling diseases in its first clinical study after 14 days of treatment
  • The EMA cited GB0139’s clinically relevant biomarker data in IPF patients which provides financial incentives, encouraging the development of drugs targeting rare diseases
  • GB0139 (formerly TD139) is an inhaled galectin-3 inhibitor, being evaluated in P-IIb GALACTIC-1 study in 450 patients with IP across 100 centers in the US the EU and Canada

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

Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval to MDS and CMML

Shots:

  • The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine
  • Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval
  • Inqovi is a novel product orally administered hypomethylating agent approved by the US and Health Canada for the treatment of MDS and CMML

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

GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Shots:

  • 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

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

Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Shots:

  • Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with the Stimuplex Onvision needle, empowering anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia.
  • It allows anesthesiologists the confidence to accurately position the needle tip inside the body for PNBs and helps the user to align the needle with the probe in a user-friendly interface leading to a reduction in procedural time
  • Onvision needle tip tracking technology indicates the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of 3mm and is expected to be available in the US in Q4’20. The solution is CE marked and is available for sale across the EU and Chile

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

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots:

  • The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.)
  • Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV over 30 minutes across all adult indications, including both monothx. and combination therapy
  • The approval for q6w dosing regimen is based on PK modeling and exposure-response analyses & was supported by an interim analysis of KEYNOTE-555 from a cohort of patients (Cohort B) treated with Keytruda (400mg, q6w). With the approvals, Keytruda has 13 indications across seven tumor types plus MSI-H tumors in Japan

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

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Shots:

  • The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin
  • The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile of the therapy in the study was consistent with the previously approved treatment of HER2-positive metastatic BC, and was well-tolerated as an adjuvant treatment in HER2-positive early BC
  • Kadcyla is an ADC and a postoperative new treatment option to improve prognosis in the treatment of HER2-positive early BC when pCR is not obtained by neoadjuvant therapy

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Pune365

Related News: Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The Treatment of HER2-Positive Early Breast Cancer After Surgery

AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Shots:

  • The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w until disease progression
  • Results: the study met its 1EPs of OS in Jun’2019, demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs., m-OS (12.9 vs 10.5 mos.)
  • Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots:

  • 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

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

MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults

  • The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
  • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
  • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

Click here ­to­ read full press release/ article | Ref: MC2 Therapeutics | Image: MC2 Therapeutics

Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

Shots:

  • The US FDA has granted FT designation for PBCAR0191 to treat advanced B-ALL. FT designation facilitates the expedited development and review of a new drug, whether alone or in combination with another drug addressing the unmet medical needs and treats a serious or life-threatening disease
  • Under the agreement with Servier, Precision will solely lead early-stage research activities and P-I execution for PBCAR0191 along with clinical supply for P-II clinical trials. Servier has an exclusive right to opt in for late-stage development and commercialization while Precision has the right to participate in the process of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the US
  • PBCAR0191 is an allogenic CART cell therapy, currently being evaluated in a P-I/IIa study evaluating PBCAR0191 in adult patients with r/r B-ALL and r/r NHL

Click here ­to­ read full press release/ article | Ref: Precision BioSciences | Image: StraitTimes

Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19

Shots:

  • Sorrento has filed an IND for STI-1499 in patients hospitalized with COVID-19. In preclinical studies, STI-1499 has demonstrated 100% neutralizing effect (in vitro) against the highly contagious D614G mutant strain at a low dose
  • Additionally, animal model data confirms the neutralizing profile and high potency of Ab, expected effective dose in human to be at least 5 times lower than current known Abs being assessed in other active trials
  • Sorrento has initiated cGMP manufacturing to produce 50,000 doses, expected to be available by the end of 2020, in anticipation of a potential EUA

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

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

The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues

Shots:

  • The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested data from two ongoing clinical trials, MANTA and MANTA-Ray assessing the effect of filgotinib (200mg) on sperm parameter
  • The authority has expressed concerns regarding the overall benefit/risk profile of the filgotinib (200mg). The company will evaluate the points raised in the CRL for discussion with the FDA and will continue to believe in the results of P-III FINCH clinical program
  • The company anticipates the study of MANTA and MANTA-RAy studies in H1’21. Filgotinib is currently under review by regulatory authorities across the globe and has received the CHMP’s positive opinion, recommending MAA for filgotinib in the EU to treat mod. to sev. RA who have responded inadequately or are intolerant to one or more disease-modifying anti-rheumatic drugs

Click here ­to­ read full press release/ article | Ref: Gilead | Image: New York Post

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Shots:

  • The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery
  • The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) + SOC intranasal corticosteroids vs PBO + intranasal corticosteroids. The studies demonstrated improvement in its 1EPs and 2EPs @24wks.
  • The approval makes the Dupixent first approved biologic in Canada for CRSwNP. Dupixent is a fully mAb inhibiting the signaling of the IL-4 and IL-13 proteins and is not an immunosuppressant

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: CHE Manager

G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Shots:

  • The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021
  • G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter clinical trials while the NDA for the therapy is under regulatory review, pursuant to FDA’s EAP
  • Trilaciclib is an investigational therapy designed to preserve bone marrow and immune system function during CT and improve patient outcomes and has received the US FDA’s BT designation in 2019

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

PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Shots:

  • The MAA submission is based on dose-finding Part 1 and confirmatory Part 2 of the FIREFISH and SUNFISH studies evaluating the efficacy and safety of Evrysdi (risdiplam) in symptomatic infants with type 1 SMA aged 2-7mos. and in people with types 2/3 SMA aged 2-25 yrs/ respectively
  • The submission also includes data from JEWELFISH study evaluating patients with all types of SMA aged 1-60yrs. prior treated with other SMA therapies. Exploratory efficacy analysis from SUNFISH Part 1 showed Evrysdi improved motor function @24mos. of treatment, Part 2 of the FIREFISH study met its 1EPs of infants sitting without support for 5sec by month 12, as assessed by BSID-III, Part 2 of the SUNFISH trial demonstrated that change from baseline in MFM-32 score was greater at 12mos.
  • Roche will grant $15M as milestones to PTC following MAA acceptance. Evrysdi is an SMN2-directed RNA splicing modifier designed to treat SMA caused by mutations in chromosome 5q leading to SMN protein deficiency

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

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Shots:

  • The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC
  • The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials, including results of P-III CASPIAN trial in ES-SCLC which used the 4wks., FD regimen during maintenance
  • If approved, the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w

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

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

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 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

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Shots:

  • The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
  • The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
  • Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

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

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots:

  • The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology
  • The study met its 1EPs & 2EPS, demonstrating OS, PFS, and ORR for the dual immunotherapy. @12.7mos. follow up mOS (15.6 mos. vs 10.9 mos.)
  • The approval marks the availability of the first dual immuno-oncology in NSCLC treatment in Canada

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

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

Click here ­to­ read full press release/ article | Ref: Gilead  | Image: The Wire Science

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

LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

Shots:

  • The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE
  • The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions and demonstrate the potential to address an unmet medical need
  • Delgocitinib (bid, topical formulation) acts by inhibiting the activation of the JAK-STAT pathway, currently being evaluated in two P-IIb studies for mild-to-severe CHE & AD. The company plans to submit the results of P-IIb CHE study in late 2020

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




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

Shots:

  • The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients
  • The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile compared with Darzalex IV in patients with RRMS, 2/3rd reduction in systemic ARRs (13% vs 34%)
  • In P-II PLEIADES study evaluates Darzalex SC + D-VMP in newly diagnosed transplant-ineligible patients & Darzalex SC + (D-Rd) in R/R patients prior treated with 1L therapy. In general, Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions

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




Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

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




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

Shots:

  • The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East
  • The study resulted in improvement in DFS, reduction in risk of disease recurrence, or death by 79% in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, also presented at ASCO 2020. Additionally, the trial will continue to assess OS
  • Tagrisso (osimertinib) is third-generation, irreversible EGFR-TKI once-daily oral tablets approved 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC in the US, Japan, China, the EU

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




Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Shots:

  • The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin
  • Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-center P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

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




UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Shots:

  • The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults
  • The usage of Brivlera in pediatric and adolescent patients is supported by the placebo-controlled partial-onset seizure studies in adults, PK study in pediatric aged 4 to 17 years of and for the achievement of similar plasma concentrations as of adults weight-based dose adaptations were practiced
  • Brivlera is an anti-epileptic drug (AED) displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) developing anticonvulsant effects, approved by Health Canada as adjunctive therapy for partial-onset seizures in patients 4 years of age and older

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




Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Shots:

  • The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
  • The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
  • MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

Click here ­to­ read full press release/ article | Ref: Merck | Image: Market Watch




Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots:

  • The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • Results: 87% patients responded to Tecartus (single infusion), including 62 % patients achieved CR, 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities
  • Tecartus is an autologous, anti-CD19 CAR T cell therapy, currently under EC review and has received EMA’s PRIME designation for r/r MCL. The therapy will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California

Click here to read full press release/ article | Ref: Kite | Image:  Stat News




Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Shots:

  • Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs
  •  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage assessed by mTSS compared with PBO
  • Across the FINCH and DARWIN trials, filgotinib(qd) demonstrated a clinical safety profile when administered as monothx./ in combination with MTX. The company expects the EC’s decision in Q3’20

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




AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Shots:

  • The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year
  • The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
  • Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

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

Related News: AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study to Treat COPD




Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Shots:

  • The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their smartphone
  • The company plans to integrate the app into Abbott’s NeuroSphere Digital Care, launched in May’2020 which is compatible with Infinity DBS System for patients with PD or essential tremor, Proclaim XR SCS system and Proclaim DRG Neurostimulation system for patients with chronic pain and chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia respectively
  • The integration across all Abbott neuromodulation technologies allows physicians to treat patients more easily within their practice who have an Abbott device and Apple smartphone. The patient controller app with personalized access to therapy will be available imminently

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




Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Shots:

  • The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm @12mos. post-procedure) and showed a high implant success rate of 98.8%
  • The company is also evaluating the device in OPTION study for patients with NVAF undergoing cardiac ablation procedure comparing it to oral anticoagulants as well as in the CHAMPION-AF trial that assess the device against NOACs in a broader OAC-eligible patient population
  • The WATCHMAN FLX device is indicated to reduce the risk of stroke in patients with NVAF by permanently closing off the left atrial appendage and is available in broader size options to treat a wider range of patient anatomies. The device receives CE mark in Mar’2019 and will immediately commence a launch of the device in the US

Click here to read full press release/ article | Ref: Businesswire | Image: Boston Scientific




Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Shots

  • The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future
  • In Nov’2019, FullFocus received the CE Mark, making it available to use in the EU. Paige has early access trials across the US, EU, and Brazil with healthcare organizations to serve patients and maintains a business continuity
  • FullFocus operates within the Paige Platform and allows users, meaning researchers and pathologists to view any digital image, regardless of the scanning platform used to generate the image

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




Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Shots:

  • The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020
  • Earlier, the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy improved clinical outcomes associated with the unmet medical need in recurrent pericarditis
  • Rilonacept (SC, qw) is a recombinant fusion protein that blocks IL-1α and IL-1β signaling and has received the US FDA’s BT designation in 2019. In 2017, Regeneron out-licensed rilonacept to Kiniksa for recurrent pericarditis under which Regeneron will receive equal profit on sales of the therapy, if approved in the US

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




Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Shots:

  • The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event
  • The 1EPs is the composite of time to the first occurrence of HF hospitalization or CV death. 2EPs included time to occurrence of CV death, time to the first occurrence of HF hospitalization, time to total HF hospitalizations (including first and recurrent events), time to the composite of all-cause mortality and time to all-cause mortality
  • Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator with its anticipated PDUFA date as Jan 20, 2021

Click here to read full press release/ article | Ref: Businesswire | Image: USA Today




US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

Click here to download printable PDF The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program instituted by the US Food and Drug Administration (FDA) in response to the COVID-19 pandemic The primary goal of the program is to expedite the availability of new treatments and vaccines to COVID-19 patients as rapidly as possible […]

The post US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines appeared first on PharmaVOICE.

Virtual Panel – Combination Products Post Marketing Safety Reporting (PMSR): An Expert Panel Discussion on PMSR Challenges and Preparation for Upcoming Reporting Expectations

Sponsored by Covance Register The PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes. In this virtual webinar, expert panelists will provide an overview of the combination product PMSR final rule, what you need to do to be prepared, common […]

The post Virtual Panel – Combination Products Post Marketing Safety Reporting (PMSR): An Expert Panel Discussion on PMSR Challenges and Preparation for Upcoming Reporting Expectations appeared first on PharmaVOICE.

How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have had to step up and work on producing guidance.

There are many
challenges that accompany RWD. Its various forms (e.g. EHRs, disease
registries, claims data) are not necessarily subject to the same
well-established regulations and protocols as clinical data. The data might be
inconsistent, unstructured, in multiple formats and it may not adhere to the
principles of FAIR data. As regulatory bodies consider RWE, they must think
about the quality of the data underpinning it.

The FDA offers
guidance

The Food and Drug Administration (FDA) took its first big step in December 2018 by publishing a framework for their real-world evidence program, which helped to lay out some of their goals and issues of importance to be addressed, such as how RWE will be used for regulatory decision-making for drugs, considerations for observational study designs and clinical trial design, data standards for submissions, regulatory issues around the use of electronic source data and more. Actual draft guidance for submitting documents using RWD and RWE for drugs and biologics then followed in May 2019.

The EMA grapples with real-world
challenges

Meanwhile in Europe, the European Medicines Agency (EMA) has also had to address the intense interest in RWD and RWE, though there are clearly concerns about whether real-world evidence can be credible evidence. In an article published in the journal Clinical Pharmacology & Therapeutics in October 2019, the EMA officials who authored it noted concerns that “acceptance of non‐RCT methodologies is tantamount to lowering the quality of evidence because these methods are prone to a myriad of undetected or undetectable biases.”

They remain optimistic
about the future for RWE, but are adamant about the importance of testing and
validation. “The ultimate key to achieving credibility is to start with an open
but ‘agnostic’ mind‐set and submit novel
methods to a fair, transparent, and prospective validation exercise,” they wrote.

The pharma response

The FDA has invited comments on its draft guidance, and the pharmaceutical industry has obliged. As reported in Policy & Medicine, a number of suggestions have come in from major players. Gilead, for instance, has proposed expanding the submissions list so that supplemental new drug applications and supplemental biologics license applications are included. Gilead has also suggested lab data be considered a source of RWD, and Novartis has suggested pharmacy claims should be considered a source for RWE. 

What is quite clear is
that we are in the early stages of what will be a long process, as regulators
work to formulate policy and guidance for a type of data that they are still
trying to fully define. Real-world data and real-world evidence have much to
offer in drug development and post-market, and it will be important to have the
guidance and cooperation of our most influential regulatory bodies.

In our next piece on
RWE, we will discuss the role of real-world evidence in the fight against
COVID-19, including a new research project spearheaded by the FDA.

Innovative Solutions to Overcome eSource Challenges

eSource (defined as data initially recorded in an electronic format) formats have provided excellent opportunities to not only streamline clinical research securely, but to increase data quality and trustworthiness. As these methods are continually reviewed for newer and better processes to be leveraged, challenges arise. In effect, many cutting-edge technologies have been developed as the […]

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MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Shots:

  • The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx
  • Re-MIND has met its 1EPs and has shown improved ORR of the tafasitamab/lenalidomide combination vs lenalidomide monothx. In Oct 2017, Tafasitamab + Lenalidomide received the US FDA’s Breakthrough Therapy Designation
  • Tafasitamab (MOR208) is an investigational Fc-engineered mAb directed against CD19 and is being evaluated in B-MIND P-III trial in combination with bendamustine vs rituximab + bendamustine in patients with r/r DLBCL

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

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

Shots:

  • The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months
  • The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also received NMPA’s Priority Review while BeiGene is currently working with BI for its commercial supply to launch in China
  • Tislelizumab (BGB-A317, 200mg, IV) is a humanized IgG4 anti–PD-1 mAb targeted to minimize binding to FcγR on macrophages and is been evaluated as a monothx and in combination to treat multiple solid tumor and hematologic cancers with 15 registration-enabling trials conducted in China and globally, including 11 P-III trials and 4 pivotal P-II trials

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

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

Shots:

  • The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks on 1L Pt-based chemotherapy
  • The study resulted in improvement in median progression-free survival (7.4 mos. vs 3.8 mos.), 47% reduced risk of disease progression or death, respond ratio (23% vs 12%), median duration of treatment in excess of 2 yrs. (24.9 mos. vs 3.7 mos.), OS (18.9 mos. vs 18.1 mos.), safe and tolerable
  • AstraZeneca and Merck & Co’s (MSD outside the United States and Canada) Lynparza (olaparib) is a first-in-class PARP inhibitor targeted to block DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR) and is approved in 65 countries

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

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

Shots:

  • Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy
  • The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% reduction in risk of disease progression and death in patients with germline BRCA mutations and 55% in patients without germline BRCA mutations with expected for sNDA submission to the NMPA for 1L monothx maintenance treatment of platinum-responsive ovarian cancer patients
  • The candidate has also received priority review status on Jan 29, 2019 and is also evaluated in NORA study for Chinese patients with recurrent ovarian cancer plus expected completion in Q3’20. Zai Lab in-licensed exclusive rights to commercialize Zejula in Mainland China, Hong Kong, and Macau from GSK

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