Recon: Gilead’s long-acting HIV drug beats Truvada in late-stage trial; Biocon seeks partner for generic weight loss drugs in China
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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