Recon: FTC expresses concern over Novo Nordisk’s desire to buy Metsera; FDA OKs Caplyta as a add-on depression treatment
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- How Congress can still get health care subsidies in place for 2026 (STAT)
- FTC raises concern about Novo Nordisk attempt to acquire obesity startup Metsera (STAT) (Reuters) (Bloomberg)
- The FDA is a mess, but don’t blame it for everything (STAT)
- Obesity Drugs May Drop to as Little as $149 a Month (New York Times) (Washington Post)
In Focus: International
- Swiss biotech returns to Boehringer Ingelheim to partner on autoimmune T cell engager (Endpoints)
- Investors back new biotech with heart disease treatment from China (STAT)
- China lifts import ban on Illumina's DNA sequencers as trade tensions ease (Endpoints)
- Gates Foundation Backs Biovac Lab to Boost Africa Vaccine Production (Bloomberg)
- Canada: Two Faster Pricing Negotiation Pathways To Target Market Access Bottlenecks (Pink Sheet)
- China Takes Major Step On Commercial Insurance For Innovative Drugs But Hurdles Ahead (Pink Sheet)
- Not just Rogaine: Biotech investors see promise in a new wave of hair loss treatments (STAT)
- FDA approves J&J’s antipsychotic drug to treat depression (STAT)
- Recursion CEO Chris Gibson out as company head after 12 years (STAT)
- Lilly moves obesity drug to late-stage trials after it shows promise (Reuters)
- AstraZeneca holds forecasts as cancer, heart drugs lift earnings (Reuters)
- Vera outlines full Phase 3 win for kidney drug, preps for FDA filing by year's end (Endpoints)
- Dyne changes plans for DM1 drug again; Dynavax licenses Vaxart's Covid vaccine (Endpoints)
- UPS, Cencora to expand their US operations; Evotec divests biosimilar business to Sandoz (Endpoints)
- Moderna struggles to sell its vaccines, posts paltry RSV sales in third quarter (Endpoints)
Medtech
- Number of Persons Responsible For Regulatory Compliance Grows Nearly 10% (MedTech Insight)
- Italy’s Responsible Person Sanctions Approach Raises Eyebrows (MedTech Insight)
- Microsoft launches 'superintelligence' team targeting medical diagnosis to start (Reuters)
- Oura’s healthcare ambitions take shape as the smart ring maker vaults to a $11B valuation (Endpoints)
- Siemens Healthineers predicts tariff impact will double (MedTech Dive)
- Medtronic’s Jason Fontana on ramping up renal denervation (MedTech Dive)
- Zimmer CEO ‘very surprised’ by Q3 sales miss (MedTech Dive)
- Qiagen inks $225M single-cell buyout as CEO prepares to step down (MedTech Dive)
- Dexcom Targets Manufacturing Stability, 15-Day Rollout To Restore Margins In 2026 (MedTech Insight)
Food & Nutrition
- Big Food’s Fight Against Kennedy Is Heating Up (New York Times)
- Trump says he’s withholding SNAP benefits until shutdown ends (The Hill)
- JBS to pay $1.1M to settle New York lawsuit over climate claims (Food Dive)
Government, Regulatory & Legal
- Appeals court judges seem skeptical of Trump administration’s defense of capping NIH overhead payments (STAT)
- Smaller Companies Next Frontier for FDA’s Voluntary Improvement Program (MedTech Insight)
- Novel Oncology Endpoints Take Time, Require Broad Outreach, US FDA Says (Pink Sheet)
- US FDA’s Richard Pazdur Says ‘No’ To CDER Director’s Spot (Pink Sheet)
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 Regulator
