Recon: FDA warns Aspen Pharmacare for sterility issues at major facility; EMA OKs AI tool in fatty liver disease studies
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- HHS agency responsible for health care quality research threatened with mass layoffs (STAT)
- Sale of Ozempic Knockoffs Is Supposed to End Soon. Telehealth Companies Aren’t Happy. (The Wall Street Journal)
- Illumina was built on DNA. Its future could be biology’s next big wave (Endpoints)
- Gilead stock slips as HHS denies reports of HIV funding cuts (Endpoints)
- Medtronic recalls embolization devices tied to 17 injuries, 4 deaths (MedTech Dive) (Reuters)
- Pfizer sells entire Haleon stake for $3.24 billion (Reuters)
- UnitedHealth eases rules on renewing some prescription drugs (Reuters)
- FDA warns Aspen Pharmacare, Africa’s biggest drugmaker, over sterility issues at a key plant (STAT)
- India's Bharat Biotech launches cell gene therapy facility, eyes product launch by 2028 (Reuters)
- ‘We’ve vanished’: U.S. aid cuts leave health workers around the world reeling (STAT)
- Eli Lilly launches weight-loss drug Mounjaro in India at $50 for 5 mg vial, beating Novo Nordisk (Reuters)
- EU health regulator clears use of AI tool in fatty liver disease trials (Reuters) (EMA)
- UK's Niox Group receives sweetened buyout proposal from Keensight Capital (Reuters)
- Novartis finally delivers gene therapy data in older SMA patients. Will they still want it? (STAT)
- Immunovant and Roivant report success in autoimmune drug’s Phase 3 trial (STAT)
- Monte Rosa reports first data for molecular glue program licensed to Novartis (Endpoints)
- FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1) (FDA)
- Sanofi to pay $600M upfront for Dren Bio’s bispecific B cell depleter (Endpoints) (Reuters)
- Cargo Therapeutics scraps R&D
- Colonoscopy and AI: Experts weigh fuzzy evidence of benefit (STAT)
- Paratek boosts commercial portfolio in move to buy Optinose and its nasal spray (Endpoints)
- A California health tech company is letting AI run medical visits, from intake to diagnosis (Endpoints)
- Quest, Google team on gen AI; GE Healthcare plans autonomous imaging (MedTech Dive)
- Cargo Therapeutics scraps R&D pipeline, axes bulk of workforce as it looks for an exit (Endpoints)
- Flagship's Ampersand gets Eli Lilly's support in $65M Series B (Endpoints)
- Roche inks $1B+ biobucks deal with UK biotech for new antibody cancer targets (Endpoints)
- US health agencies announce plan to strengthen infant formula supply and quality (Reuters) (STAT)
- HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families (FDA)
- Food Safety Jeopardized by Onslaught of Funding and Staff Cuts (NYTimes)
- As U.S. punts on ultra-processed food, California seeks to ban ‘particularly harmful’ ones from school lunches (STAT)
- How to protect the American egg supply from avian flu (STAT)
- Trump admin looks to allow meat processers to permanently run faster line speeds (Food Dive)
- NIH cancels funding for landmark diabetes study at a time of focus on chronic disease (STAT)
- US Senate Democrats demand reversal of CDC mass firings (Reuters)
- ME/CFS research program shuts down at Columbia after Trump cuts (STAT)
- USDA to invest up to $100 million in projects to combat bird flu (Reuters)
- Tariffs are paused for USMCA-compliant goods. How can companies qualify? (MedTech Dive)
- Monogram robot wins FDA OK; Vicarious hit by supplier woes (MedTech Dive)
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