Recon: FDA clears Roche, Lilly Alzheimer’s blood tests; Regenxbio gene therapy trial halted by FDA again
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance (Reuters) (Forbes)
- FDA pauses Regenxbio gene therapy trial again due to safety concerns (STAT) (Reuters)
- Capricor's Duchenne cell therapy gets PDUFA date extended as FDA reviews new data (Endpoints) (Reuters)
- FDA digital health leader promises generative AI regulatory guidance is coming (STAT)
- Lawmakers urge FDA to enact new China policies after 3 gene therapy trial deaths (BioSpace)
- US health department seeks public feedback on vaccine guidelines after Trump order (Reuters)
- Clinical research ‘incubators’ urged by ex-FDAer Woodcock (Pink Sheet)
- FDA’s expedited IND pilot comes into focus (FDA Law Blog)
In Focus: International
- GSK scores regulatory wins for chronic hepatitis B drug, cancer therapy (Reuters)
- Sweden suffers two-pronged attack on availability of generic and innovative drugs (Pink Sheet)
- Scholar Rock withdraws Europe filing for muscle weakness drug, plans resubmission (Reuters)
- EMA pilot cuts approval times for global post-marketing changes by more than half (Pink Sheet)
- Canada on using AI to generate RWE for HTAs: Declare it, justify it, validate it (Pink Sheet)
- Lilly’s Onswik weekly insulin shot backed for English funding ahead of marketing approval (Pink Sheet)
- NZ expands access to Jardiance, Jardiamet, Trulicity, Victoza to 30,000 more T2D patients (Pink Sheet)
- Who was here before? Sharing pharmacovigilance inspection history could shape next visit (Pink Sheet)
- Eli Lilly launches oral weight-loss drug Foundayo in UK (Reuters)
- Notified Body closures signal a difficult transition period for EU regulation (Medtech Insight)
Pharma & Biotech
- Roche bets up to $2.3B on Hanmi’s early-stage muscle-building obesity asset (Endpoints) (BioSpace)
- Option-to-acquire deals remain rare in biotech's buzzy M&A season (Endpoints)
- Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone (BioSpace)
- Inside Moderna and Merck’s cancer vaccine triumph (STAT)
- A cure for HIV would be a triumph. But it shouldn’t harm survivors (STAT)
- Indian pharma has little reason to fear Trump (Bloomberg)
Medtech
- FDA device recalls: Records jumped 28% in 2026, but distinct events barely moved (Medtech Insight)
- Nearly 40,000 eye drop bottles are recalled over potential contamination (New York Times)
- France warns of 300,000 potentially unsafe condoms (Reuters)
- FDA adds two behavioral health firms to TEMPO pilot (MedTech Dive)
- Two FDA convenience kit alerts linked to Huons drug components (Medtech Insight)
- CMS grants NTAP for Aidoc’s foundation-model AI, a first for broad diagnostic tools (Medtech Insight)
- FastWave’s Artero enters pivotal trial, betting speed, simplicity can crack a crowding IVL market (Medtech Insight)
- Sonova unveils new AI-powered hearing-aid platform to support growth targets (Reuters)
- MiniMed starts shipping new insulin pump with Abbott-made sensor (MedTech Dive)
- Siemens Healthineers, Philips awarded ARPA-H funds for stroke robots (MedTech Dive)
Food & Nutrition
- US health agencies report 55 cases of E. coli and salmonella infections tied to alfalfa sprouts (Reuters) (New York Times)
- Americans bought 12% less soda under new SNAP restrictions, study says (STAT)
- Michigan reports about 3% weekly rise in cyclosporiasis cases as outbreak begins to slow (Reuters)
- Moldy peanuts can Be deadly. The solution is more mold (Bloomberg)
- Somali child hunger crisis deepens as facilities close due to aid cuts, UNICEF says (Reuters)
Government & Legal
- US court orders Guardant to pay $245 million in DNA sequencing patent dispute (Reuters)
- Medicaid transgender care rule sets precedent that could restrict coverage of other drugs (STAT)
- Medicare makes it harder for antibiotics to win enhanced payment (Pink Sheet)
- Patent application buyouts are fair game for antitrust scrutiny, FTC says in Enbrel dispute (Pink Sheet)
- Medicare denies being ‘excessively stringent’ in reviews of add-on payments (Pink Sheet)
- CDC’s new director cannot break vaccine policy deadlock, even as Schwartz assures staff of support (Pink Sheet)
- Kennedy questions vaccination guidelines following Trump’s order to break up MMR (BioSpace)
- Trump offered state Medicaid programs lower prices on weight-loss drugs. Most are rejecting the deal (Politico)
- Fauci's lawyers set up legal defense fund as US probes multiply (Reuters)
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.
