Regulatory Focus™ > News Articles > 2021 > 11 > Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to

Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to donate 70M vaccine doses

Posted 16 November 2021 | By Michael Mezher 

Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to donate 70M vaccine doses

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer asks FDA to authorize COVID-19 pill for unvaccinated people (NYTimes)
  • As Big Pharma and Hospitals Battle Over Drug Discounts, Patients Miss Out on Millions in Benefits (KHN)
  • Report says drugmakers impose unjustified U.S. price increases; spending on AbbVie drug rises $1.4 billion (Reuters) (BioPharmaDive) (Fierce)
  • Pharmacy chains defend actions as landmark U.S. opioid trial nears its end (Reuters)
  • Biogen's research chief Alfred Sandrock to retire (Reuters) (STAT)
  • Biogen’s pricey Alzheimer’s drug will fuel record premium hikes for Medicare Part B (STAT)
  • Moderna offers NIH co-ownership of COVID vaccine patent amid dispute with government (CBS)
In Focus: International
  • Top scientist defends decision to sell AstraZeneca vaccine at a profit (FT)
  • Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries (NYTimes) (Reuters)
  • Moderna says EU to donate over 70 mln doses of its COVID-19 vaccine (Reuters) (Politico)
  • Pfizer to conduct trials of antiviral COVID-19 pill in Russia (Reuters)
Coronavirus Pandemic
  • Nearly 100 children near DC receive incorrect dose of vaccine at clinic (The Hill) (Reuters)
  • Another one bites the dust: Novartis, Molecular Partners and their antiviral get the boot from NIH Covid study (Endpoints)
Pharma & Biotech
  • Viatris launched two versions of its interchangeable insulin biosimilar. Why? (Fierce)
  • Apellis' eye med application on track for next year after FDA OKs inclusion of phase 2 data (Fierce)
  • AHA: J&J's Invokana chases AZ's Farxiga and Lilly's Jardiance with phase 3 heart failure win (Fierce)
  • Eye disease specialists venture into M&A with a buyout deal worth up to $126M (Endpoints)
  • Bristol Myers and Janssen race toward PhIII with a next-gen blood thinner (Endpoints)
  • In quest to eliminate tropical diseases, Merck KGaA will submit anti-worming drug for approval in young children (Endpoints)
  • Exclusive: Big-name academics and investors are quietly preparing a slate of new (epi)genome editing companies (Endpoints)
  • Cassava being investigated by unnamed 'government agencies'; Rocket Pharma gives updated data on Danon disease (Endpoints)
  • Backed by Sean Harper and Beth Seidenberg, an LA biotech scores a massive $250M crossover ahead of 2022 IPO (Endpoints)
  • A Czech biotech bets big on rising ADC player LegoChem as part of licensing pact aimed at solid tumors (Endpoints)
  • CRISPR, ViaCyte beat Vertex to the clinic with diabetes cell therapy that evades the immune system (Endpoints)
  • Eyeing an accelerated BLA, PhaseBio says its monoclonal antibody reversed the dangerous effects of AstraZeneca's blood thinner (Endpoints)
  • Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices (MedtechInsight)
  • Medtronic nets FDA capsule camera clearance for at-home gastrointestinal screenings (Fierce)
  • Geneoscopy nabs $105M to advance RNA-based gut tests for early colorectal cancer screening (Fierce)
  • How Does The Eudamed Module On Notified Bodies And Certificates Work? (MedtechInsight)
  • ‘It’s going to set the bar pretty high’: A path forward for trusted AI in breast cancer risk prediction (STAT)
Government, Regulatory & Legal
  • Defense lashes out at key witness in Elizabeth Holmes fraud trial (CNBC)
  • House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval (Pink Sheet)
  • Philips Claims Order A Hurdle To Fixing Sleep Apnea Devices (Law360)
  • Mallinckrodt Exec Says Acthar Price Hikes Were Necessary (Law360)
  • Illumina Tells Jury BGI Copied Its DNA Sequencing Patents (Law360)
  • High Court Won't Hear Breast Implant Suits Against J&J Unit (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.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.