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

• 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)

• 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 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)

• 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)