Recon: FDA staff raise no major concerns for Grail multi-cancer test ahead of adcomm; Trump admin drafting order to exert control over NIH grant funding
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA updates regulations to advance innovative alternatives to animal testing (FDA)
- Trump asked budget chief to draft order bringing health research funding under his control (Politico) (New York Times)
- Grail rallies as FDA staff flags no major concerns for multi-cancer test (Reuters)
- Bill Cassidy urges FDA nominee to reject Trump’s vaccine claim (Politico)
- FDA approves therapy to treat ataxia (The Pharma Letter) (Fierce Pharma)
- FDA approves Lilly's oral SERD combo for second-line breast cancer therapy (Endpoints) (Reuters)
- CDC works on standard definition for measles deaths as cases rise (Reuters)
- FDA accepts Tanabe’s NDA for dersimelagon (The Pharma Letter)
- FDA says initial rejections of new drugs have declined (Endpoints)
- FDA wants to change the narrative on complete response letters with new report (Pink Sheet)
- CDER director Mike Davis eyes AI as solution to institutional memory loss (Pink Sheet)
In Focus: International
- UK government committees call for probe into US pharma deal (Endpoints)
- Ex-banker eyeing top WHO job says agency can tap outside money (Bloomberg)
- Zealand Pharma's short bowel syndrome drug wins backing from EU panel (Reuters) (Pink Sheet)
- EMA backs EU approval for Corcept’s, Impact’s ovarian cancer drugs Lifyorli, Sepalna (Pink Sheet)
- Incyte’s Povofortay scores EMA win as US review continues (Pink Sheet)
- Blockbuster-tipped encaleret and novel psoriasis hopeful zasocitinib head new EMA filings (Pink Sheet)
- AstraZeneca’s, Mirum’s orphan bone disease disorder drugs among new EU filings (Pink Sheet) (Fierce Pharma)
- China sets ambitious goals for global drug and biotech expansion in new five-year plan (Endpoints)
- EMA backs Novo’s Frehemgo for hemophilia as US decision nears (Pink Sheet)
- Takeda’s Mimrylo, Gilead’s Bixlenvo eye EU market amid US wins (Pink Sheet)
Pharma & Biotech
- Novo’s plan to hit $23B in revenue by 2035 leaves investors wanting (BioSpace) (Bloomberg)
- Telix and radioisotope maker ITM merge in deal worth up to $2.35B (Endpoints) (STAT)
- Electra says $350M IPO will help it become a commercial biotech (Endpoints) (BioPharma Dive)
- ADARx targets $319M IPO as TRexBio, Retension join filing queue (Endpoints) (Reuters)
- Beacon says gene therapy succeeds in key trial of rare eye disease XLRP (Endpoints) (Reuters)
- Anthropic starts allowing some life sciences researchers to use Mythos (Endpoints)
- Alkermes’ orexin agonist shows potential to treat ADHD in early-stage trial (STAT)
- Bristol Myers scraps $100M Orum-partnered cancer drug after reviewing phase 1 data (Endpoints)
- J&J's Caplyta meets main goal of bipolar mania study (Reuters)
- Bayer offloads cancer drug Stivarga to Grünenthal for up to $431M as new competition looms (Fierce Pharma)
Medtech
- Neptune Medical secures FDA nod for endoscopy robot (MedTech Dive)
- RAPS Convergence: RWE gains regulatory traction but device data gaps remain a hurdle (Medtech Insight)
- Medtronic hit with second class I recall for Bravo CF capsule delivery device as injuries reach 184 (Medtech Insight)
- Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI (MedTech Dive)
- AI-derived advertising claims land Starkey in hot water with watchdog (Medtech Insight)
- Oura targets $15.62 billion valuation in US IPO, setting stage for fall listings (Reuters)
- MethodSense pitches a ‘consultant in the box’ to speed device compliance (Medtech Insight)
- Chicago man first-ever to receive mind-controlled bionic arm in human trial (Medtech Insight)
Food & Nutrition
- Ultra-processed food has links to food safety (Food Safety News)
- Analysis of EU RASFF data finds aflatoxins, imported foods lead mycotoxin-related notifications (Food Safety Magazine)
- USDA-FSIS to roll out listeria environmental sampling program nationwide at RTE facilities (Food Safety Magazine)
- FDA warns Texas beverage companies about acidified food, unapproved drug claims (Food Safety News)
- Finland assesses safety of plant-based dairy products (Food Safety News)
Government & Legal
- Trump touts pharma deals to offer cheaper drugs to state Medicaid programs (STAT) (Endpoints)
- Kennedy renews attacks on vaccines at Children’s Health Defense conference (STAT) (New York Times)
- Patients sue GLP-1 drugmakers over risk of sudden vision loss (Wall Street Journal)
- Trump says he will demand some childhood vaccines be split into five shots (Reuters)
- Internal CMS email confirms Globe and Guard exemption strategy (Endpoints)
- Kennedy announces new effort to speed up autism diagnoses (STAT)
- Medicare set to expand ACCESS model with the addition of four chronic conditions (Medtech Insight)
- Two hospital systems settle US probe over transgender care billing for $9.5 million (Reuters)
- The NIH budget should be $100 billion per year (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.
