Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Hansoh, Samsung Biologics hit with FDA write-ups after inspections (Fierce Pharma)
- FDA puts Bright Minds drug on partial hold, stock tanks (Endpoints)
- Generic drug industry pushes for earlier FDA calls on 180-day forfeiture (Pink Sheet)
- Washington state resident dies from bird flu following exposure to infected cattle (AP News)
- New York reports first measles death in 30 years during outbreak (Bloomberg)
- Myopia ‘fast progressors’ may not offer escape path for Sydnexis’ SYD-101 (Pink Sheet)
- HHS’ peptide compounding enforcement policy silent on advertising claims (Pink Sheet)
In Focus: International
- Merck KGaA is selling its CDMO business in the US to Lonza (Endpoints) (The Pharma Letter)
- Accord reports US bridging data for serplulimab in SCLC, and wins UK approval for ranibizumab biosimilar (The Pharma Letter)
- EC approves Alfasigma’s linerixibat for PBC (The Pharma Letter)
- FAST-EU scale-up raises capacity questions as poor trial dossiers add to regulatory burden (Pink Sheet)
- Global eCTD v4.0 rollout advances with new Swiss, US moves (Pink Sheet)
- Sun Pharma stops eye-care drug production at Indian plant amid quality issues (BioSpace)
Pharma & Biotech
- Karyopharm, deep in debt, to sell itself in bankruptcy (BioPharma Dive) (BioSpace)
- Novartis ends BioArctic brain delivery collaboration (The Pharma Letter) (Fierce Biotech)
- AbbVie discloses up to $757M deal with Beijing-based Brise for preclinical migraine meds (Endpoints)
- Bayer CEO says company is ‘working on’ MFN in the US (Endpoints)
- CinRx, Sam Waksal's Graviton team up on ROCK2 for PAH, other cardio conditions (Endpoints)
- Teva gains rights to biosimilars from Samsung Bioepis (The Pharma Letter)
- InventisBio's nomelcitinib meets phase 3 goals in psoriasis (The Pharma Letter)
- Acumen Pharma tanks as it drops Alzheimer’s candidate (The Pharma Letter)
- Cerus' blood-safety system meets main goal in late-stage trial (Reuters)
- Theriva Biologics sells antibiotic-degrading enzyme portfolio to Biossil Labs (The Pharma Letter)
Medtech
- Philips reaches DOJ agreement over device recall, books €288 million provision in Q3 (Reuters)
- False-negative risk prompts class I recall of Werfen’s HemosIL AcuStar HIT test (Medtech Insight)
- Abbott starts pivotal trial for mitral valve replacement device (MedTech Dive)
- Brainomix says biomarker qualification is next step for its FDA-cleared lung AI software (Medtech Insight)
- Elixir DynamX Bioadaptor pulls ahead of DES after 6 months In pooled patient analysis (Medtech Insight)
- 12-month data show Heartflow’s CT-guided PCI planning matches invasive IVUS outcomes (Medtech Insight)
- Abbott, Dexcom grapple with diabetes coverage ahead of planned Medicare expansion (MedTech Dive)
- No transmitter, no alerts without a phone: Senseonics’ Freedom CGM trade-offs (Medtech Insight)
- Illumina lifts 2026 outlook as NovaSeq X placements rise but instrument revenue slips (Medtech Insight)
- AdvaMed chair Mick Farrell shares his top priorities, challenges for the medtech industry (MedTech Dive)
Food & Nutrition
- CAP makes policy recommendations for stronger federal food safety oversight, calls out MAHA ‘failures’ (Food Safety Magazine)
- EU recommends monitoring chlorinated paraffins in food through 2029 (Food Safety Magazine)
Government & Legal
- Trump administration said to plan rolling back pregnancy-related job protections (New York Times)
- New York Medicaid spending balloons $45 billion over five years (Bloomberg)
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.