Recon: Adcomm backs Grail’s cancer test; Lilly, China’s InnoCare sign $3.35B deal
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Abortion pills, vaccines and food safety: FDA nominee to face Senate panel (New York Times) (AP News)
- FDA adcomm votes in favor of benefit-risk of Grail’s cancer test (Endpoints) (Reuters)
- White House plan to increase control of NIH grants appears ‘dead’ (STAT) (Politico)
- FDA approves Elevar’s lirafugratinib (The Pharma Letter)
- Eli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry (BioSpace) (Reuters)
- FDA should improve audits of stumbling third-party review program, GAO says (Medtech Insight)
- FDA grounds CoGenT gene therapy pilot after a single review (Pink Sheet)
- Contract manufacturing woes mount for Seikagaku’s Condoliase after second FDA CRL, clinical issues fixed (Pink Sheet)
- CDC confirms first measles-related death of 2026, does not disclose state (Reuters)
- HHS considers reclassifying some islet cell products as organs instead of biologics (Pink Sheet)
In Focus: International
- China's InnoCare, Eli Lilly sign collaboration deal worth up to $3.35 billion (Reuters) (Endpoints)
- EMA review triggers sweeping restrictions on long-established ipidacrine drugs (Pink Sheet)
- Missing evidence prompts EU JCA termination for Lilly/Innovent’s sintilimab (Pink Sheet)
- Almost there? EU officials hint pharma reform nearing adoption (Pink Sheet)
- EU closes the gap on ICH Q12, but industry uptake remains slow (The Pharma Letter)
- Malaysia's IHH's unit appeals Tokyo court's rejection of Daiichi Sankyo damages claim (Reuters)
- From ECG methods to study design: ICH to close regional gaps in cardiac safety testing (Pink Sheet)
- US trade officials hear case on declining German drug prices (Endpoints)
- US pledges $267 million more to fight Ebola in central Africa (Reuters)
- China eyes central role on global biopharma stage (Pink Sheet)
Pharma & Biotech
- Roche kidney drug's phase 3 win sets up path to accelerated approval (Endpoints) (BioPharma Dive)
- Merck's drug for diabetes-related eye disease meets trial goal (Reuters)
- Viking touts once-a-month maintenance data for its weight loss candidate (Endpoints) (BioPharma Dive)
- Enveda, an AI drugmaker, banks $311M in venture funding (BioPharma Dive) (Fierce Biotech)
- Compounder Empower receives FDA warning letter over GLP-1s (Endpoints)
- Roche pens backloaded $2B deal with Atavistik to discover allosteric CVRM drugs (Fierce Biotech) (BioSpace)
- Boehringer adds $250M to value of Variant pact by expanding into cardiovascular disease (Fierce Biotech)
- Kyverna says long-term data bolster FDA submission for rare autoimmune CAR-T (Endpoints) (BioSpace)
- Celldex falls on safety concern, even as chronic hives drug succeeds in Phase 3 trials (Endpoints) (BioPharma Dive)
- Amgen reports a phase 3 win with Sjögren’s drug candidate (BioPharma Dive)
Medtech
- Cordis wins FDA approval for sirolimus-eluting balloon (MedTech Dive)
- CVRx names John Landry as CFO (MedTech Dive)
- Basecamp raises $140M Series C, unveils six-program pipeline in test of its AI (Endpoints)
- In radiology, AI is blurring the line between technology development and clinical practice (STAT)
- How Elucid plans to outperform HeartFlow without computational fluid dynamics (Medtech Insight)
- Senseonics widens its AID reach with Beta Bionics as pump integrations become the growth path (Medtech Insight)
Food & Nutrition
- US packaged food makers could help cut diet-related deaths, study shows (Reuters)
- Potential infant formula illnesses probed in the UK (Food Safety News)
- FDA identifies listeria, E. coli outbreaks (Food Safety News)
- EPA announces glyphosate safety review efforts, decision expected by early 2027; Experts question scientific rigor (Food Safety Magazine)
- India tightens proposed food warning labels in setback to industry (Reuters)
Government & Legal
- Trump's Department of War bets $47M on Flagship biotechs to develop countermeasures (Fierce Biotech) (The Pharma Letter)
- CMS sets preliminary cuts to Medicare lab reimbursement rates (MedTech Dive) (Medtech Insight)
- Lilly’s retatrutide: Legal dispute with FDA heating up, both sides meet multiple times (Pink Sheet)
- Oral chemotherapy costs: House hearing focuses on small fix for big issue (Pink Sheet)
- DOJ, EPA reach proposed settlement with Puerto Rican sterilizer firm over EtO violations (Medtech Insight)
- Why a US senator wants a biotech leader in the White House who ‘has the president’s ear’ (Fierce Biotech)
- US tariffs round two: The Sept. 29 reckoning for API makers without a deal (Pink Sheet)
- Kennedy drew $4 million in book advances from publisher who also monetized MAHA (New York Times)
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.
