Recon: FDA warns Aspen Pharmacare for sterility issues at major facility; EMA OKs AI tool in fatty liver disease studies

• 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)