Recon: Eli Lilly’s experimental obesity drug slashes weight in study; FDA approves first at-home device for depression
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Postscripts from the frontlines of Trump’s attacks on science: no simple happy endings (STAT)
- Lilly’s next-gen obesity drug delivers major weight loss in Phase 3 trial, but with many discontinuations (STAT)
- US FDA approves first at-home device for depression (Reuters)
- Fighting Dementia Could Be as Easy as the Shingles Vaccine (Bloomberg)
- Senate Rejects GOP Health Plan as Insurance Premium Spike Looms (Bloomberg)
- Here’s Looking at You, OTC Drugs: FDA Requests Information to Plan for Public Meeting on Increasing Access to Nonprescription Drugs and Issues New MaPP on OTC Switches and Generics (FDA Law Blog)
- Europe’s pharma policy shakeup moves forward toward enactment (STAT)
- A weakened bill to cut off Chinese biotech firms nears passage, after years of changes (STAT)
- Zealand inks deal with Chinese biotech as it spells out broader metabolic disease ambitions (Endpoints)
- WHO chief still hopes Trump administration will rethink withdrawal (Reuters)
- China’s Pushes for a Baby Boom With a New Tax on Birth Control (Bloomberg)
- US Health Deal Halted by Kenyan Court on Privacy Concerns (Bloomberg)
- J&J’s two-drug combo blocked tumors in advanced multiple myeloma (STAT)
- Myocarditis is a rare but real Covid vaccine side effect. A new study sheds light on what might cause it (STAT)
- Now is the time to launch mpox vaccine booster trials (STAT)
- Wave’s ‘gym bro’ obesity drug is story over substance (STAT)
- Umoja delays first readout for in vivo CAR-T therapy (Endpoints)
- Rezolute crashes as its only drug fails in Phase 3 (Endpoints)
- AC Immune says early biomarker data are promising in Parkinson's, but clinical benefit remains unclear (Endpoints)
- Rhythm reports Imcivree’s key weight loss data from Phase 2 Prader-Willi trial (Endpoints)
- Health tech investors are getting creative with exits (Endpoints)
- Weight loss biotech gets $70M, snags Amgen's obesity commercial leader as CEO (Endpoints)
- Medra Raises $52 Million to Speed Drug Discovery With AI Robots (Bloomberg)
- Moderna Founder Warns US Doubts on Science Threaten Biotech Edge (Bloomberg)
- Novo Nordisk Is Trading as If Obesity Drug Craze Never Happened (Bloomberg)
- Welsh Carson-backed Lumexa Imaging raises $463 million in US IPO (Reuters)
- Intuitive wins 3 new indications for da Vinci SP system (MedTech Dive)
- FDA pilots allowing digital health devices access to CMS payment program (MedTech Dive)
- Natera acquires Foresight Diagnostics for up to $450M (MedTech Dive)
- Abbott Fired a Warning Shot on Baby Formula — Then Launched a Lobbying Blitz (Bloomberg)
- San Francisco’s move against ultraprocessed food could lead to wave of lawsuits (Food Dive)
- HHS health IT chief hints at a new approach to EHR certification (STAT)
- In expert panel, FDA says ‘door is open’ for testosterone labeling revisions (STAT)
- Exclusive: NAACP pressing for ‘equity-first’ AI standards in medicine (Reuters)
- US senators push USDA for urgent action on bird flu vaccine (Reuters)
- Texas Files Antitrust Suit Against Epic Systems Over Health Data (Bloomberg)
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