Recon: Pfizer seeks authorization for bivalent booster in kids under 5; FDA takes firmer stance on dangling accelerated approvals

ReconRecon | 05 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer applies for FDA authorization for Omicron-retooled vaccine booster in kids under 5 (Reuters)
  • FDA Takes Tougher Line on Fast-Tracked Drugs (WSJ)
  • Do Verve’s gene edits pass down to patients’ children? The FDA wants to know (Fierce)
  • FDA remains silent on orphan drug exclusivity after last year's court loss (Endpoints)
  • US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases (Pink Sheet)
  • US monthly costs for biosimilars 'substantially higher' than Germany or Switzerland, JAMA research finds (Endpoints)
  • FDA's drug shortages leader wants companies to start reporting increases in demand (Endpoints) (Pink Sheet)
  • Biden administration poised to lift monkeypox emergency declaration (Washington Post)
  • Before making unbiased pulse oximeters, researchers need a better way to measure skin tone (STAT)
  • Advocates warily eye legal challenge to abortion pills (The Hill)
  • Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab (Pink Sheet)
  • A Conversation With Anthony Fauci on Covid Lessons: Lisa Jarvis (Bloomberg)
In Focus: International
  • EMA To Address Problems With CTIS By Key January Deadline (Pink Sheet)
  • Novel Vaccines Among Wide Ranging EU Plans To Boost Health Threat Preparedness (Pink Sheet)
  • EU Countries Slam Transferable Exclusivity Voucher Proposal (Pink Sheet)
  • EMA pulls an opioid from the 1950s used to treat dry cough (Endpoints) (Pink Sheet)
  • Drop in COVID alertness could create deadly new variant, WHO says (Reuters)
  • Indonesian families sue drug regulator, govt after children die of kidney disease (Reuters)
  • New Zealand announces review of its handling of COVID-19 pandemic (Reuters)
Pharma & Biotech
  • Pfizer to invest more than $2.5 billion to expand European manufacturing (Reuters) (Fierce)
  • Pfizer bolsters blockbuster investment spree with $750M outlay at one of its biggest manufacturing plants (Fierce)
  • AAM’s Dan Leonard, president of generic drug lobby, ousted (STAT)
  • In Face of Multiple Patent Cliffs, Novartis’ Prostate Cancer Drug Shows Promise (Biospace) (Fierce) (Bloomberg)
  • Valneva: "on track" with Chikungunya vaccine after positive data (Reuters
  • Amgen says experimental obesity drug has promising durability Reuters)
  • Salarius Pharmaceuticals sees withdrawals, 3 of 13 patient responders in sarcoma trial (Endpoints)
  • Merck could keep its patent edge by shifting Keytruda cancer drug to a simple shot  (Reuters)
  • J&J Says It Won’t Make Offer for Horizon Therapeutics (Bloomberg) (Biospace)
  • Beam jumps back into off-the-shelf CAR-T race after FDA lifts clinical hold (Fierce)
  • In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use (Fierce)
  • Crucial Council Of EU Debate On Medical Device Regulation Crisis Countdown (MedTech Insight)
  • Why EU Must Reform Regulation And Funding For Life-Saving Cancer Biomarker Tests (MedTech Insight)
  • View From German Industry: MDR At The Turning Point (MedTech Insight)
  • Some Essential Cardiac Devices In Short Supply FDA Warns (MedTech Insight)
  • BD finds cybersecurity flaw that could allow hackers to disable infusion pumps (Fierce)
  • Medtronic completes enrollment in pivotal trial evaluating first-of-its kind pulsed field ablation catheters for patients with atrial fibrillation (Biospace)
  • An AI model to predict kidney damage, trained on data from veterans, works less well in women (STAT)
Government, Regulatory & Legal
  • Whistleblower Hopes Supreme Court Will Curb DOJ Dismissal Power Bloomberg)
  • Teva Hit With Antitrust Claims for Alleged Epipen-Nuvigil Scheme (Bloomberg)
  • Tylenol Consumer Drops Titanium Dioxide Suit Against J&J Unit (Bloomberg)
  • AstraZeneca partner FibroGen slaps former employee with trade secret theft lawsuit (Fierce)
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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