Recon: FDA panel votes against Otsuka, Lundbeck PTSD drug; Biogen announces $2B upgrades to NC facilities

• FDA taps biotech veteran George Tidmarsh to lead drug center (STAT) (Reuters)
• A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry (STAT)
• The FDA’s new SSRI experts have long questioned antidepressant use (Endpoints)
• Otsuka, Lundbeck’s PTSD Drug Fails to Win US FDA Panel Support (Bloomberg) (Reuters)
• Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths (AP) (FDA)
• Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy (Fierce)
• The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear (STAT)

• Moderna cancels plans to build mRNA manufacturing site in Japan (Endpoints)
• Shares of Brazil's Fleury jump on reports of talks with Rede D'Or (Reuters)
• A Passport To Streamlined Medtech Access Under UK Life Sciences Plan (MedTech Insight)
• World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings (Pink Sheet)
• Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS (Pink Sheet)
• US rejects WHO pandemic changes to global health rules (Reuters)

• Biotech VC Omega Funds raises $647 million fund (STAT)
• Alkermes drug helped narcolepsy patients stay awake in Phase 2 trial (STAT)
• Omega Funds matches size of 2021 fund with $647M for life sciences startups (Endpoints)
• Roche's IL-33 antibody misses in COPD after Sanofi and Regeneron's drug fell short (Endpoints)
• GSK to lay off 150 workers in MA as site transitions to focus on R&D (Endpoints)
• Alkermes gets a mid-stage narcolepsy hit, but trails Takeda in R&D race (Endpoints)
• Biogen beefs up North Carolina manufacturing ahead of potential drug tariff storm (Reuters)
• Activist Investors Target $30 Billion Tied Up in Biotech Stocks (Bloomberg)
• Lilly enlists 'Happy Gilmore 2' star as Zepbound partner (Fierce Pharma)
• Ferring summons star power to celebrate World IVF Day with firsthand fertility stories (Fierce Pharma)
• Layoff Tracker: GSK, Sail, BioNTech Cut Staff for Second Time This Year (BioSpace)

• Heartflow files for IPO (MedTech Dive)
• Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric (MedTech Dive)
• Risk management, legacy tech pose major threats to healthcare firms, report finds (MedTech Dive)
• Carlsmed seeks up to $103M IPO haul to fuel spine surgery growth (MedTech Dive)
• Medtronic wins US appeal to overturn $106.5 mln heart-valve patent verdict (Reuters)
• Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out (MedTech Insight)

• Food industry pushes traceability rule changes amid Trump deregulation effort (Food Dive)
• Study: CDC Funding for State-Level Programs Improves Foodborne Illness Outbreak Detection (Food Safety)

• HHS’ move against the WHO: a line in the sand, or political theater? (STAT)
• A SPAC seeks $500M IPO to make drugs in the US (Endpoints)
• Congressional forecaster says Trump health research cuts would lead to fewer new drugs (Reuters)
• Sometimes, Timing is Everything (FDA Law Blog)