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)
Medtech
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.