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March 6, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
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