Recon: Gilead to buy CymaBay for $4.3B; FDA approves Takeda’s oral eosinophilic esophagitis drug

• Gilead to acquire CymaBay for $4.3 billion, adding new treatment for liver disease (STAT)
• FDA finalizes rule on using master files in biologics applications (Endpoints)
• US FDA’s Congressional Education Becoming More Essential With Key Member Departures (MedTech Insight)
• Takeda's treatment becomes first oral therapy for esophageal condition in US (Reuters)
• Weight-loss drugs tied to benefit after hip replacement (Reuters)
• Psychedelic investment continues to ramp up (STAT)
• US FDA staff raises no new concerns about Abbott's heart device (Reuters)
• PBM Legislation And The Meaning Of ‘Meaningful’ Reform (Pink Sheet)

• Trade Body Call To Address Key Challenges Of The EHDS Regulation For Medtech (MedTech Insight)
• Catalent sales edge past estimates as focus shifts to Novo deal (Reuters)
• Navigating The EU's Revised Clinical Trial Disclosure Rules (Pink Sheet)
• EMA’s Cancer ‘Pathfinder’ Project Targets Conditional Approvals, Endpoints & RWE (Pink Sheet)
• ‘A Maze Of Rules’: EFPIA On EU’s Proposed Health Data Sharing Law (Pink Sheet)
• Czech Republic To Assess Impact Of National Drug Shortage Measures In The EU (Pink Sheet)

• A sweeping form of search-and-replace editing has come for mRNA (Endpoints)
• Moderna shares slide on concerns over drop in RSV vaccine efficacy (Reuters)
• Iambic unveils new AI model besting AlphaFold as protein models rocket ahead (Endpoints)
• CSL shares down 5% after post-heart attack drug disappoints in late-stage test (Endpoints)
• Centessa 2.0 with a twist: Medicxi combines six immuno-derm startups with $100M (Endpoints)
• Pfizer joins Super Bowl ad lineup, toasting Katalin Karikó and other innovators with 'Here’s to Science' spot (Endpoints)
• AstraZeneca encourages NHL fans to get 'body checked' for cancer (Endpoints)
• Novo Holdings’ $16.5B bid for Catalent; Novartis’ $2.9B bolt-on; Endpoints Slack interview with John Evans; and more (Endpoints)
• Novo Nordisk's controlling shareholder plans to invest about $35 bln by 2030 (Reuters)
• PTC's Emflaza to face generics this month after Aurobindo's final FDA nod (Fierce Pharma)
• After rejection, FDA re-accepts Xspray's application for would-be rival to BMS' Sprycel (Fierce Pharma)
• Bayer, Moderna-Backed Metagenomi’s Stock Crashes 31% in Friday IPO Debut (BioSpace)

• Fresenius brings dialysis technology to US with FDA clearance (MedTech Dive)
• Cue Health axes more jobs amid declining test sales (MedTech Dive)
• Illumina cut 12% of global staff over past year: CEO (MedTech Dive)
• Surgical VR May Look Like Fun, But It Is No Game For Osso’s CEO (MedTech Insight)
• Diagnostics CEOs In Triplicate Weigh In On Upcoming Hurdles (MedTech Insight)

• States are ramping up scrutiny of health transactions, as more provider groups look for buyers (STAT)
• A flurry of research misconduct cases has universities scrambling to protect themselves (STAT)
• Novo Nordisk secures first two wins in legal battle against compounding pharmacies, wellness centers (Endpoints)
• Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not (FDA Law Blog)