Recon: UK unveils recommendations for regulating AI in medicine; FDA halts new enrollment in Biohaven epilepsy trials
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Seehafer selection as first deputy commissioner of technology and AI draws praise, questions (Medtech Insight)
- FDA expands indication for Bayer’s Hyrnuo (The Pharma Letter) (Fierce Pharma)
- UCB’s Cimzia wins FDA Breakthrough therapy status for antiphospholipid syndrome (The Pharma Letter)
- FDA pauses new enrollment in Biohaven's epilepsy drug trials (Reuters) (BioSpace)
- FDA withdraws Krazati's colorectal cancer indication after confirmatory trial miss (The Pharma Letter) (Endpoints)
- FDA is open to novel approaches for evaluating psychedelics (Bloomberg)
- NME reviews and costs drop, along with FDA’s priority review voucher fee (Pink Sheet)
- Smaller application package among FDA IND reform goals (Pink Sheet)
- FDA advisory committee meetings remain rare despite leadership changes (Pink Sheet)
In Focus: International
- UK unveils recommendations for regulating AI in medicine (STAT) (Medtech Insight)
- In draft guidance, NICE rebuffs Gilead's twice-a-year PrEP med for national coverage (Fierce Pharma) (The Pharma Letter)
- Novo Nordisk says Wegovy approved in China for liver disease MASH (Reuters)
- Mexico bets on Brazil regulatory reliance for swifter 45-day drug approvals (Pink Sheet)
- First ever ATMP joint clinical assessment report highlights evidentiary challenges (Pink Sheet)
- Pooled purchasing in EU beats extended IPR to incentivize innovation, says Spanish minister (Pink Sheet)
- EMA’s dossier maturity checks raise new questions for drugmakers (Pink Sheet)
- New procurement opportunities open in LMICs for pediatric cancer drugmakers (Pink Sheet)
- West Nile virus infections cause three deaths in the Netherlands (Reuters)
Pharma & Biotech
- Major Novartis shareholder calls for board shake-up after drug trial setbacks (Reuters) (Fierce Pharma)
- Expanding its biopharma plans, Anthropic looks for a life sciences dealmaker (Endpoints)
- Evommune scraps eczema drug after trial miss, shares plunge (Reuters) (Endpoints)
- Amgen’s lung cancer treatment Imdelltra notches new major victory (Endpoints)
- AbbVie's menstrual migraine treatment meets late-stage study goal (Reuters)
- NodThera, a decade-old NLRP3 player, plans phase 3 and a rebrand (Endpoints)
- A new immuno-oncology play raises $225M for a next-generation drug (BioPharma Dive)
- Samsung Bio, waiting to break into peptides, nets $262M manufacturing deal with unnamed EU pharma (Fierce Pharma)
- Encoded raises $275M series F for Dravet syndrome gene therapy (BioSpace) (Endpoints)
- Tyra finds ray of sunshine in otherwise cloudy phase 2 bladder cancer data (Endpoints) (BioSpace)
Medtech
- FDA opens 510(k) pathway for eight device types (Medtech Insight)
- ARPA-H to invest $62 million to develop FDA-authorized AI to help treat heart failure (STAT) (Endpoints)
- UpFront’s finger-prick stroke blood test gets first-of-its-kind CE mark (Medtech Insight)
- Labcorp acquires MLM Medical Labs in global expansion (MedTech Dive)
- Boston Scientific says cyberattack makes 2026 guidance ‘unlikely’ to be met (Medtech Insight) (MedTech Dive)
- UK-based Kneu Health launches Parkinson’s disease monitoring on Apple Watch (Medtech Insight)
- Zimmer restructures Americas leadership team (MedTech Dive)
- 5 takeaways from Oura’s IPO filing (MedTech Dive)
Food & Nutrition
- CDC reporting almost 20,000 confirmed patients in Cyclospora outbreak (Reuters)
- FDA reports 22 cases of salmonella infections linked to broccoli sprouts (Reuters)
- German food safety officials say glycerol exposure limits for beverages should also apply to solid foods (Food Safety Magazine)
- Trump executive order seeks meat inspection modernization by cutting ‘unnecessary’ requirements, expanding state programs (Food Safety Magazine)
- India signals stricter red warning labels in setback for Big Food (Reuters)
Government & Legal
- Senate HELP committee announces hearings for three Trump health nominees (Politico)
- CMS approach to easing small biotechs into Medicare price negotiation draws concerns (Pink Sheet)
- US appeals court skeptical of bid to curtail abortion pill access (Reuters)
- Ex-FDA chief counsel Mark Raza joins Hogan Lovells Cadwalader (Pink Sheet)
- Drugmakers cherry pick launch regions as MFN creates ‘policy environment like an earthquake’ (BioSpace)
- Trump administration working on more drug pricing deals, Oz says (Bloomberg)
- Where things stand with EU product liability directive transposition (Drug & Device Law)
- Five midterm races to watch that could be crucial for vaccine policy (STAT)
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.
