RECON: FDA halts Pepaxto trials; Pfizer nears $8B in vax sales for Q2

ReconRecon | 28 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer sells $7.8 billion in Covid shots in the second quarter, raises 2021 guidance on vaccine sales (CNBC)
  • AstraZeneca castoff draws $123M wager on CXCR2 antagonist as Arena lines up a buyout option (Endpoints)
  • Opinion: US FDA Should Take Its Time With COVID Vaccine BLAs (Pink Sheet)
  • Biden Is Considering A Vaccine Or Testing Mandate For Federal Workers (NPR)
  • White House tells agencies to mandate masks in federal buildings in hot spots (Reuters)
  • Senators Urge HHS to Support Prescription Drug Imports From Canada (FDA News)
In Focus: International
  • EU signs deal with GSK for supply of potential COVID drug (Reuters)
  • Complix and Jiangsu Nhwa to collaborate on treatment of CNS Diseases (Pharmafile)
Coronavirus Pandemic
  • Efficacy of Pfizer/BioNTech Covid vaccine slips to 84% after six months, data show (STAT)
  • AZ publishes new real-world safety data for COVID-19 vaccine Vaxzevria (PM Live)
  • In CureVac's failure, a possible verdict on the past (and future) of mRNA vaccines (Endpoints)
  • England scraps quarantine for fully vaccinated U.S., EU arrivals (Reuters)
  • Legal wrangles hold up U.S. vaccine donations to India (Reuters)
  • Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response (PharmaTimes)
  • Scientists model 'true prevalence' of COVID-19 throughout pandemic (PNAS)
Pharma & Biotech
  • In halting confirmatory trial for Oncopeptides' accelerated approval, FDA notes increased risk of death (Endpoints) (FDA)
  • Amgen strengthens portfolio with Teneobio buy (Pharmaletter)
  • Deerfield and ARCH back a new $200M SPAC run by California VC firm (Endpoints)
  • Massive Selloff Hits US, HK-Listed China Health Cos, Clouds Sunny Prospects (Scrip)
  • Biogen and Eisai present new data for controversial Alzheimer's drug Aduhelm at AAIC (PM Live)
  • Biogen pulled Aduhelm paper after JAMA demanded edits (Axios) (Reuters)
  • Biogen pushes for broad CMS coverage of Alzheimer's drug — while Eli Lilly looks to escape an NCD (Endpoints)
  • Any Medicare Study Requirements For Alzheimer’s Drugs Should Be Time Limited, CMS Told (Pink Sheet)
  • Deep Genomics, now flush with cash, plans to take dozens of RNA therapies to the clinic (Endpoints)
  • AGTC Moves Past Biogen With Ophthalmic Gene Therapy (Scrip)
  • USP, NIST, others collaborate to enable standardisation of AAV quality measurement (EPR)
  • FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022 (Pink Sheet)
  • France issues moratorium on prion research after fatal brain disease strikes two lab workers (Science)
  • Cassidy joins SpringWorks as CMO (Biocentury)
  • Ipsen strengthens its pre-clinical oncology pipeline with BAKX deal (Pharmaletter)
  • GlaxoSmithKline punts a key Zejula combo study in ovarian cancer with added setbacks on ICOS and RSV (Endpoints)
  • Bristol Myers' Opdivo turns the boat around in Q2 as manufacturing issues haunt CAR-T launch (Endpoints)
  • FDA Grants Rare Pediatric Disease Designation to Day One for Treatment of Pediatric Low-Grade Glioma (Rare Daily)
  • Recognizing Hepatitis R&D on World Hepatitis Day (PhRMA)
  • Pharmacoequity: a new goal for ending disparities in U.S. health care (STAT)
  • RARE-X Appoints Charlene Son Rigby as Chief Executive Officer (Rare Daily)
  • RareStone and Tencent Collaborate on Service Ecosystem Focused on Rare Disease Patients in China (Rare Daily)
  • Abeona Reports New Positive Data from Study of Gene Therapy for Sanfilippo Syndrome (Rare Daily)
  • GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound (MedTech Dive)
  • BD Closes on 6th Acquisition for Fiscal 2021 (MD+DI)
  • Boston Scientific tops pre-pandemic results in Q2, expects similar trends in H2 (MedTech Dive)
  • Handing Production to the Robots? It’s Getting Cheap and Easy (MD+DI)
  • Designing Medical Devices for Manufacturability: How to Do It and Why You Should (MD+DI)
  • What's Next for Artificial Intelligence and Medical Devices? (MD+DI)
Government, Regulatory & Legal
  • Johnson & Johnson Held In Contempt In Illinois Talc Trial (Law360)
  • US sells Wu-Tang Clan album to cover Shkreli debt (Endpoints)
  • Bio-Rad And 10X Agree To End Patent War (Law360)
  • Ex-FDA Chief Counsel On Relationships, Consensus-Building (Law360)
  • Medical Products Supply Chain Week in Review (JDSupra)
  • Judge Urged To Rethink Ruling Perrigo Hid $1.9B Irish Tax Bill (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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