Recon: FDA delays decision on Biogen’s ALS drug; European prosecutor’s office investigating COVID vaccine contracts

ReconRecon | 17 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biogen’s ALS ambitions on pause as FDA delays approval decision by 3 months (Fierce) (Reuters) (BioSpace)
  • FDA Moves to Pull Controversial Preterm Birth Drug From the Market (MedPage Today)
  • FDA punts Travere's rare kidney disease NDA for three months, requesting REMS update (Endpoints) (Fierce)
  • Ensuring consistency in product quality: How FDA's requests for more info will be formalized (Endpoints)
  • Lawmakers push NIH to disclose steps being taken to ensure clinical trial results are reported (STAT)
  • Comparative Claims In Product Promotions: FDA Isn’t Entirely Leaving It To Firms To ‘Duke It Out’ (Pink Sheet)
  • Research Money Bonanza Spurs Contest to Hose New Federal Agency (Bloomberg)
  • Abbott recalls some liquid baby formula over bottle defect (Reuters)
  • Lower-cost U.S. hearing aids go on sale today (Reuters)
  • Medicare Drug Payment Demonstration May Advance In 2023 Under Executive Order (Pink Sheet) (Endpoints)
  • Ex-JAMA Chief: Cut the Hype, Spin in Published Studies (MedPage Today)
  • Biden takes aim at Big Pharma, Republicans in California (Reuters)
In Focus: International
  • European Prosecutor’s Office confirms it’s investigating European Union Covid vaccine contracts (STAT) (Politico) (EPPO)
  • Dengue Vaccine Qdenga & Nine Drugs Win EMA Thumbs Up (Pink Sheet) (Reuters) (Endpoints)
  • Europe: Cross-Country HTA of Gene Therapy Libmeldy Calls For Price Cut (Pink Sheet)
  • Moderna halts vaccine supply to COVAX in favor of new agreement for omicron-adjusted shots in 2023 (Fierce)
  • Serum Institute to produce Ebola vaccine for use in Uganda outbreak (Reuters)
  • Gates Pledges $1.2 Billion to Speed End of Crippling Poliovirus (Bloomberg) (Reuters)
  • With no monkeypox vaccine at home, frustrated Mexicans go abroad (Reuters)
Pharma & Biotech
  • ‘Pharma burnout’: Industry reputation slumps in first half of 2022, study finds (Endpoints)
  • Biosimilar approvals on the rise after a two-year slump — Amgen report (Endpoints)
  • The top 10 vaccine companies worldwide (Fierce)
  • Josh Bilenker’s last biotech sold for $8 billion. His next one is cloaked in mystery but loaded with money (STAT)
  • Gilead, MacroGenics Unite Against Hematologic Cancers in $1.7B Biobuck Deal (Biospace)
    After 2020 flop, Milestone’s arrhythmia nasal spray hits in phase 3 (Fierce) (Endpoints)
  • Sage, Biogen post fresh phase 3 depression data as FDA filing nears completion (Fierce)
  • What to know about Roche’s experimental Alzheimer’s treatment (STAT)
  • Fierce Biotech Layoff Tracker: Adagio rebrand Invivyd lays off staff; GreenLight slashes 25% of workforce (Fierce) (Fierce)
  • NeuBase lays off 60% of employees as it swaps out antisense focus for gene editing tech endorsed by George Church (Endpoints)
  • Salix report uncovers climbing death rates from chronic liver disease (Fierce)
  • Call For Risk-Based Extension For Legacy Products And No Sell-Off Deadline Under EU MDR (MedTech Insight)
  • “Decisive And Rapid” Action Needed On UK Regulations As Target Dates Looking Unlikely (MedTech Insight)
  • Europe’s ‘Regulatory Lasagna’: Commission Facing Yet More AI Act Criticism (MedTech Insight)
  • A green revolution: FDA hands down emergency OK to plant-based surgical face mask (Fierce)
  • LASIK Comments Show Divided Opinions As FDA Extends Feedback Period (MedTech Insight)
  • Regulating Software As A Medical Device Will Take Paradigm Shift, Former FDA Chief Counsel Says (MedTech Insight)
Government, Regulatory & Legal
  • Pfizer takes Vyndagel copay fight to Supreme Court, decrying ‘staggeringly overbroad’ anti-kickback rule (Fierce)
  • Supreme Court rejects Novartis' request for stay in Gilenya patent battle (Endpoints) (Reuters)
  • Lilly Sues Dr. Reddy’s to Block Copies of Forteo Bone-Loss Drug (Bloomberg)
  • Biotech ‘New Era’ in Store if Patent Revamp Overcomes Opposition (Bloomberg)
  • Grifols Defeats Whistleblower’s Vid to Revive Drug Fraud Suit (Bloomberg)
  • Alcon, J&J Vision settle for $75M in contact lens price-fixing case (Fierce) (MedTech Dive)
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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