Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children (WSJ) (STAT) (Reuters)
- US pivots to ‘harm reduction’ after 107,000 overdose deaths last year (FT)
- Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA (Endpoints)
- Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (Reuters)
- FDA oversight of pharma manufacturing facilities plunges during the pandemic (STAT)
- Pfizer stops enrollment in Paxlovid trial in standard-risk population (Reuters) (STAT)
- Mental-Health Startup Cerebral Investigated by FTC (WSJ) (Reuters)
- Baby formula makers raced for FDA approval. They may be waiting a while (Reuters)
- EU drugs watchdog in rolling review of Pfizer-BioNTech's variant vaccine (Reuters) (EMA)
- Shionogi to provide global access to its antibiotics, with focus on poor countries, as resistance fears grow (Endpoints) (STAT)
- Spanish PM: Moderna to invest $523M into the country to boost vaccine production (Endpoints)
- Valneva reaches settlement with Britain on COVID-19 vaccine deal termination (Reuters)
- WTO Summit Extended As Officials Scramble For Consensus (Law360)
- The FDA could do more to promote generic competition: Here’s how (Brookings)
- Two days after showing strong pediatric cancer data, Day One taps $150M in public capital (Endpoints)
- No introductions necessary: A TCR upstart with deep-pocket backers partners with one of the new players in the hot gene editing field (Endpoints)
- MorphoSys out-licenses two antibodies to secretive ARCH biotech as it pushes forward with lead Constellation work (Endpoints)
- Brookings issues recommendations for generic drug competition as PDUFA VI expiration looms (Endpoints)
- After ulcerative colitis flop, Immunic regains some momentum with multiple sclerosis update (Fierce)
- FDA warns Spanish drug and API manufacturer over multiple production line problems (Endpoints)
- Third Rock pushes newest fund over $1B line as it marks 15 years in venture capital (Endpoints)
- Califf Floats Third-Party Supply Chain Monitoring To Fight Product Shortages (Pink Sheet)
- 'Huge Problem': FDA Leaders Fear Collapsing Trust In Agency (Law360)
- Outset Medical pauses at-home dialysis shipments, sending stock to all-time low (Fierce)
- Digital pathology player Proscia procures $37M to expand its reach (Fierce)
- Supreme Court sides with hospitals on Medicare drug pay dispute (STAT)
- Inside Johnson & Johnson’s bankruptcy two-step (FT)
- Impax Got Earliest Possible Generic Opana Entry, Jury Hears (Law360)
- Bristol-Myers Sues To Block Rival's Generic Leukemia Drug (Law360)
- Amarin Beats Class Claims Of Duping Investors At 3rd Circ. (Law360)
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