Recon: FDA advisory panel endorses Lilly’s Alzheimer’s therapy; Genfit, Ipsen get accelerated approval for liver disease drug

• FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment (STAT) (Endpoints)
• US FDA grants accelerated approval to Genfit and Ipsen's liver disease drug (Reuters) (Endpoints)
• Millions fewer people may need statins, a new study suggests. But guidelines have yet to agree (STAT)
• BIO's new CEO takes a patriotic pivot to win back Congress, pushing industry to rethink China relationship (Endpoints)
• Paxlovid did not beat placebo in Stanford-led long Covid study (Endpoints)
• Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections (FDA Law Blog)

• UK medtech raises $100M for two-in-one urinary incontinence treatment (Endpoints)
• EU Substances Of Human Origin Regulation Set To Pass Final Milestones (Pink Sheet)
• ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership (Pink Sheet)
• Switzerland Adopts Changes To Human Research & Clinical Trial Regulations (Pink Sheet)
• European Parliament Has Missed The Chance to Boost Orphan Drug Development (Pink Sheet)
• Oliver Bisazza Warns That EU’s Innovation Issues May Create More Reliance On Medtech Imports (Pink Sheet)

• Sage Therapeutics says rare disease drug found to be safe in mid-stage study (Reuters)
• Eli Lilly’s Alzheimer’s candidate, Bob Langer’s new startup, and other biotech news you need to know (STAT)
• Biotech co-founded by entrepreneur Bob Langer is testing a new approach to developing obesity treatments (STAT)
• Pivoting to ‘ADC-like’ approach, Versant-backed startup gets $90M Series C (Endpoints)
• New obesity biotech Syntis Bio launches with early-stage alternative to GLP-1s (Endpoints)
• ARCH backs lab instrument company that wants to help demystify how cells talk to each other (Endpoints)
• Exclusive: Auxilius raises $10M to help biotechs manage clinical trial finances (Endpoints)
• US FDA’s Yim Hints At Revisiting Biosimilar Suffix Naming Convention, Reassures On Immunogenicity (Pink Sheet)

• Tweezers? Wrenches? Researchers plot prosthetics’ future with tools, not hands (STAT)
• Blood tests for cancer detection aren’t yet ready for prime time (STAT)
• Medical device trials still don’t enroll enough women, study finds (STAT)
• AI Assurance Lab Concept Leaves Potential Regulatory Gap (MedTech Insight)
• Physician And myTomorrows CEO Discusses FDA’s New Program To Advance Clinical Trial Diversity (MedTech Insight)
• Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence (MedTech Insight)

• GSK asks to appeal Delaware ruling allowing Zantac cases to go forward (Reuters)
• Melinda French Gates, going solo, aims to influence reproductive rights in the U.S. (STAT)
• Empathy should guide responses to reported vaccine injuries (STAT)
• Oscar stakes its future on companies dumping worker health benefits (Endpoints)
• Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz (Pink Sheet)