Recon: Gilead’s long-acting HIV drug beats Truvada in late-stage trial; Biocon seeks partner for generic weight loss drugs in China

• Gilead’s twice-yearly antiviral protected women from HIV infection in large trial (STAT)
• Lilly takes more actions against unapproved versions of Mounjaro (STAT) (Endpoints)
• A primer on HELIOS-B, an enormous stock-moving event for Alnylam Pharmaceuticals (STAT)
• New study bolsters evidence rare genetic mutation can delay early Alzheimer’s (STAT)
• Flat-Lining US FDA: Failure To Invest May Have Consequences (MedTech Insight)
• US FDA May See Second Straight Year of Non-User Fee Funding Cuts From Congress (MedTech Insight)
• US FDA Creating Rare Disease ‘Hub’ To Serve As Center Of Excellence (Pink Sheet)
• Food companies wade carefully into weight-loss waters (Reuters)

• Revised EU Trial Transparency Rules Go Live With Last Minute Changes To Address Confidentiality Concerns (Pink Sheet)
• AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation (MedTech Insight)
• India's Biocon seeks partner to test generic Wegovy, Ozempic in China (Reuters)
• iOnctura raises €80M to advance early-stage rare eye cancer treatment (Endpoints)
• Forbion's new €75M fund; Cara Therapeutics to cut workforce after trial failure (Endpoints)
• EMA Explains How To Draw Up Shortage Prevention & Mitigation Plans (Pink Sheet)
• China Sets Clinical Trial Record But Starting Studies Can Be Challenging (Pink Sheet)

• A biotech’s binary bet ends badly (STAT)
• Roche partners with Ascidian Therapeutics to develop gene therapies (Reuters)
• Gilead tested an antibody many times. A small biotech salvages it, with $40M and ‘conviction’ elsewhere (Endpoints)
• Jazz Pharmaceuticals' tremor drug misses main goal in mid-stage study (Reuters)
• Aphaia hits primary endpoint with oral glucose drug in mid-stage prediabetes trial (Endpoints)
• Samsung Bio and Baxter dial up manufacturing deal to $223M (Endpoints)
• Blank check, please? Three healthcare SPACs reveal their IPO plans (Endpoints)
• Vanda rejects buyout offers, pans 'opportunistic attempts' at securing its shares at a discount (Fierce Pharma)

• AMR, UTI, Breathomics And 3D Printing Technology Innovators Profiled At BioWales 2024 (MedTech Insight)
• Radiologists Ask For AI-Focused Reimbursement Pathway (MedTech Insight)
• FDA official sets out approach to AI in medical devices (MedTech Dive)
• Medtronic’s president of global regions set to retire in June (MedTech Dive)
• Agilent to cut 3% of employees as sluggish lab equipment market persists (MedTech Dive)

• Novant Health calls off North Carolina hospital deal, giving a win to the FTC (STAT)
• Amazon Pharmacy expands $5 monthly subscription to Medicare patients (Reuters)
• Judge questions 'unusual' DOJ plan to pay lead-testing device victims (Reuters)
• Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says (Pink Sheet)
• US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia (Pink Sheet)
• Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote (Pink Sheet)