Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population

ReconRecon
| 15 June 2022 | By Michael Mezher 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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