Recon: Lilly’s bimagrumab plus Novo’s Wegovy prove potent for weight management; MHRA adds second AI airlock
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA chief’s goals of ‘radical transparency’ threatened by agency cuts (STAT)
- Eli Lilly drug bimagrumab saves muscle mass when added to Novo's Wegovy (Seeking Alpha)
- The decades-long journey to Gilead’s twice-a-year HIV prevention drug lenacapavir (STAT)
- Inside the FDA’s ‘listening’ tour: Officials agree US lags behind China on drug development (Endpoints)
- Last Friday was a Good Day for Those Who Want to Litigate Against the Federal Government (FDA Law Blog)
In Focus: International
- CHMP recommends five new drugs, reconsiders Eli Lilly’s Kisunla (Endpoints)
- UK's NICE says Lilly, Eisai's Alzheimer's drugs aren't worth national coverage (Endpoints)
- Trump aid cuts deal a blow to HIV prevention in Africa (Reuters)
- China's Sciwind's GLP-1 shows similar weight loss to Novo's Wegovy, study finds (Reuters)
- Ireland Sees Thousands of Jobs at Risk From US Pharma Tariffs (Bloomberg)
Pharma & Biotech
- Novo Nordisk’s amylin obesity drug keeps performing like Zepbound (STAT)
- Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results (STAT) (Endpoints)
- GLP-1 reduced migraine frequency by nearly half, in a pilot study (STAT)
- Compass claims Phase 3 win in depression for psilocybin drug, moves closer to FDA filing (Endpoints)
- Illumina to buy SomaLogic for $350M upfront, pushing further into proteomics (Endpoints)
- Compass shares tumble after depression drug fails to impress (Reuters)
- Roche’s bispecific-ADC combo keeps lymphoma at bay (Fierce Pharma)
Medtech
- Billionaire Hoffman Backs Brain Startup Using AI, Ultrasound (Bloomberg)
- Labcorp was the blockbuster Supreme Court case that wasn’t (Reuters)
- MHRA Opens Second AI Airlock Program For Applications (MedTech Insight)
- Stealth Mode AI Imaging Startup Faction Imaging Raises $10M (MedTech Insight)
- Remepy To Embed AI In Next-Gen Digital Therapeutics For Personalized Neuroimmune Modulation (MedTech Insight)
- Virtual Incision appoints former Intuitive exec as CEO (MedTech Dive)
- Rise in VC activity tees up ‘strong year’ for medtech funding: PitchBook (MedTech Dive)
Food & Nutrition
- Grocers pressed to detail link between tariffs and food prices (Food Dive)
- FDA Seeks Input on New Method for Ranking Chemicals in Food for Post-Market Assessments (Food Safety)
Government, Regulatory & Legal
- Doctors lose Medicare pay bump in Senate version of tax bill (STAT)
- Senate Republicans debate Medicaid options as hospitals move to shape legislation (STAT)
- Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official (STAT)
- Pharma companies are weighing how a drug’s IP location could impact tariffs (Endpoints)
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.
