Recon: German Merck acquires Silence Therapeutics for $1.3B; China's Hansoh Pharma strikes $15B drug deal with Roche
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA sets up board to oversee drug exclusivity determinations (Reuters)
- Trump to create new NIH division, task force for women's health (Reuters)
- CMS gains permissive exclusion authority: Implications for pharma and medical device companies (FDA Law Blog)
- International trials blog raises questions about FDA communications, definition of ‘policy’ (Pink Sheet)
- CDRH’s FY 2027 proposed guidances: Shorter lists, focused on software and AI (FDA Law Blog)
- Industry worries about misbranding exposure in FDA’s distributed manufacturing path (Pink Sheet)
- FDA issues warning over Eurofins’ selective recording that ‘compromises’ data (BioSpace)
- User fee deflation: PDUFA goals letter shrinking along with fees (Pink Sheet)
- Consumer reps rarely swung FDA advisory committee votes, but often sided with majority (Pink Sheet)
- Reading EPARs and FDA reviews beyond the approval announcement (The Pharma Letter)
In Focus: International
- Germany's Merck buys Silence Therapeutics in $1.3 billion RNA drug deal (Reuters)
- Chinese government pursues export ban on select biopharma tech (Endpoints) (Fierce Biotech)
- CHMP endorses Eli Lilly’s GLP-1 pill and three other new drugs (Endpoints) (Reuters)
- Ascendis’s US-approved Yuviwel gains EMA backing for achondroplasia (Pink Sheet)
- Pharma wants UK’s risk-based AI rules to work across global development programs (Pink Sheet)
- EMA’s first phased review delivers thumbs up for Rasonque in under 150 days (Pink Sheet)
- Japan grants global-first price to GSK’s novel HBV drug bepirovirsen (Pink Sheet)
- India widens cancer drug price caps, lowering prices of 137 medicines (Reuters)
- Roche puts future German investments 'on hold' (Reuters)
- Sth Korean court backs Samsung Biologics’ manufacturing processes (The Pharma Letter)
- Australia confirms first H5N1 bird flu case on sub-Antarctic Macquarie Island (Reuters)
Pharma & Biotech
- China's Hansoh Pharma strikes drug deal with Roche worth over $15 billion (Reuters) (Endpoints)
- Virginia is for manufacturing: State leads by winning $12.6B in onshoring projects (Endpoints)
- OrbiMed raises $3B in new life sciences funds, including $1B+ for Asia (Endpoints) (BioSpace)
- Merck KGaA buys Silence Therapeutics in $1.3 billion RNA drug deal (Reuters) (Bloomberg)
- HK-listed Metis TechBio, Eli Lilly strike drug-delivery deal worth up to $1.1 billion (Reuters)
- After FDA rejection, Disc Medicine's 'sun allergy' drug hits home run in phase 3 (Endpoints) (Reuters)
- Gilead’s IBD drug eliminated symptoms for patients, mid-stage study finds (STAT) (Reuters)
- Veradermics' oral Rogaine wins again at growing hair in late-stage trial (Endpoints) (Reuters)
- Novartis scraps Fabhalta study in lupus nephritis (Endpoints) (Reuters)
- EyePoint to halve workforce after experimental drug fails second late-stage trial (Reuters)
Medtech
- FDA flags Edwards heart-valve delivery system issue after death, injury (Reuters) (MedTech Dive)
- MiniMed completes separation from Medtronic (MedTech Dive)
- AMA releases governance framework for agentic AI in healthcare (MedTech Dive)
- Labcorp to buy BioReference assets for up to $872M (MedTech Dive)
- MHRA’s 2030 vision puts lifetime monitoring at center of medtech plans (Medtech Insight)
- EY pulse of medtech industry report shows record revenues of $650B in 2025; AI remains focus (Medtech Insight)
- Dexcom hopes strong CONNECT data will break the CGM reimbursement quagmire (Medtech Insight)
- EndoQuest Robotics hires chief commercial officer (MedTech Dive)
Food & Nutrition
- RFK Jr. seeks policy win in defining ultraprocessed foods (Politico)
- FDA warns importers about Salmonella, recalls and supplier verification failures (Food Safety News)
- UN says Gaza malnutrition gains fragile as commercial supplies halt (Reuters)
- India's food regulator proposes ban on added sugars in infant foods (Reuters)
Government & Legal
- US strikes one-year deal to fund maternal and newborn health donations in poorest countries (Reuters)
- Trump administration advances plan for peptide drugs favored by RFK Jr. (AP News)
- A CDC page supporting Covid-19 vaccines for people wanting a baby went dark (Endpoints)
- Bipartisan House bill would exempt ostomy, urological supplies from Medicare competitive bidding (Medtech Insight)
- Top immunology association divided over $8.4-billion California ballot measure to fund the field, emails show (STAT)
- New Medicare plans have fewer benefits, higher costs (Wall Street Journal)
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.
