Recon: Judge bars compounders from making copies of Lilly’s weight loss drugs; PTAB invalidates two Moderna COVID vaccine patents
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Live updates: Marty Makary, Trump’s pick for FDA commissioner, testifies before Senate panel (STAT)
- Trump's FDA chief pick Makary to face overhauling agency, keeping Kennedy happy (Reuters)
- US judge ruling for FDA bars copies of Lilly weight loss drug (Reuters)
- Judge issues preliminary injunction blocking Trump cuts to NIH research overhead payments (STAT)
- How the race for the next obesity drug is shaping up (STAT)
- Pfizer, BioNTech Get PTAB To Invalidate Moderna Vaccine IP (Law 360) (Reuters)
- Jazz Pharmaceuticals to buy Chimerix for $935 million (Reuters)
- On path to likely confirmation as NIH director, Bhattacharya toes the party line (STAT)
- CDC invites back about 180 fired employees, including some who help fight outbreaks (STAT) (AP)
- No news is good news? Merck KGaA quiet on potential SpringWorks takeover (Endpoints)
- Bavarian Nordic CEO says it can take years to move pharma manufacturing to the US (Endpoints)
- Lilly, Pfizer invest in UK startup's seed round for neurodegeneration protein degraders (Endpoints)
- Novartis not panicking over potential US pharmaceutical tariffs, chairman says (Reuters)
- South African health agency calls for coal-fired power station phase-out (Reuters)
- Analysis: Competition Increases Amid China Medtech Market Growth (MedTech Insight)
- Galderma to discuss U.S. tariffs with retailers, sees "moving target" (Reuters)
- New radiopharmaceutical heading to the FDA after Phase 3 win (STAT)
- Roche/BioNTech experimental vaccine shows early promise in pancreatic cancer (Reuters)
- US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients (Reuters)
- Novo Nordisk to sell obesity drug Wegovy direct to patients at lower price (STAT) (Reuters)
- U.S. FDA places BioNTech's malaria vaccine study on clinical hold (Reuters)
- Novo Nordisk looks into starting GLP-1 drug trials for addiction (Endpoints)
- Denali stops some work on ALS drug after analysis showed no impact on key biomarker (Endpoints)
- Swiss biotech ends Phase 2 study in Alzheimer's shortly after Lilly and Biogen did the same (Endpoints)
- Italy's Amplifon posts 2024 margin below guidance, shares drop 12% (Reuters)
- Trump’s early actions imperil efforts to improve AI’s performance in medicine (STAT)
- Trump administration policies could create headwinds across healthcare: Fitch (MedTech Dive)
- Philips pulls endovascular implant from market after 20 injuries (MedTech Dive)
- Trump’s trade war heats up as countries retaliate against tariffs (MedTech Dive)
- Staar Surgical names Stephen Farrell as CEO (MedTech Dive)
- Medical device firms brace for effect of White House tariffs (MedTech Dive)
- Novo Nordisk will join legal row over FDA's removal of semaglutide from shortage list (Endpoints)
- Some malaria, TB programme cuts reversed by US, sources say (Reuters)
- Hospitals line up to sue Blue Cross, opting out of $2.8 bln settlement (Reuters)
- DOJ Position on Administrative Law Judges (FDA Law Blog)
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