Recon: Gilead to buy CymaBay for $4.3B; FDA approves Takeda’s oral eosinophilic esophagitis drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
