Recon: FDA authorizes updated COVID vaccines; NICE finds Alzheimer’s drug Leqembi too pricey for NHS use

• US FDA clears COVID shots targeting newer variants ahead of fall campaign (Reuters)
• Oprah, Walz and other Democrats hammer reproductive freedom message at DNC (STAT)
• First real-world analysis of Merck's Ebola vaccine reveals 84% efficacy during DRC outbreak (Fierce Pharma)
• FDA defends Shuren’s tenure after report raises ethics concerns (MedTech Dive)
• FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices (MedTech Insight)
• Musk's Neuralink says second trial implant went well, no thread retraction issue (Reuters)

• U.K.’s cost-effectiveness agency gives negative review of Alzheimer’s drug Leqembi (STAT) (Reuters)
• Fujifilm Diosynth opens new UK facility; Bora completes Emergent factory buy (Endpoints)
• Updated: Chinese government indicts Japanese Astellas employee for espionage (Endpoints)
• LinkedIn post lands Vertex in hot water with MHRA over breach of UK ad regulations (Fierce Pharma)
• Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects (Fierce Pharma)
• Supreme Group buys UK agency BioStrata, extending deal spree (Fierce Pharma)
• Criticisms About EU MDR’s Rule 11 For Software Classification Are ‘Unfounded’ (MedTech Insight)

• Gene therapy pioneer Jim Wilson believes he can commercialize rare-disease drugs in a tough climate (STAT)
• Alzheimer’s drug may raise the risk of brain bleed in patients with Down syndrome (STAT)
• Merck Ebola vaccine Ervebo shown to offer substantial protection (STAT)
• Digital therapeutics pioneer Pear’s treatments get a second life, a year after bankruptcy (STAT)
• Q&A: GSK CSO Tony Wood on staying out of obesity, 'careful' cancer ambitions, and AI's future in R&D (Endpoints)
• Versant and Novartis build 'Chinook 2.0' for RNA therapies in kidney diseases (Endpoints)
• Illumina Ventures sets out for $300M third fund (Endpoints)
• BridgeBio forms another offshoot with $300M in commitments (Endpoints)
• In launching epinephrine nasal spray, ARS Pharma has a 'blue sky opportunity,' analyst says (Fierce Pharma)
• PAPA can you hear me? BioTek reMEDys in rare disease awareness push (Fierce Pharma)
• Growing Republica Havas hires execs to get into New York groove (Fierce Pharma)
• Sustainability is increasingly important in pharma, but several hurdles are slowing the effort: survey (Fierce Pharma)
• In drug development, diversity must be extended to preclinical research (STAT)

• Procept wins FDA clearance for updated prostate surgery robot (MedTech Dive)
• FDA’s plan to expand device surveillance faces challenges, GAO finds (MedTech Dive)
• Masimo’s consumer audio brands attract more suitors (MedTech Dive)
• Zoll to buy Vyaire’s ventilator business with $37M auction bid (MedTech Dive)
• J&J Acquires Heart Failure Implant Company V-Wave For Up To $1.7Bn, Expanding Its Medtech Portfolio In Cardiology (MedTech Insight)
• Agendia Aims To Reshape Breast Cancer Care With Predictive Genomic Tests (MedTech Insight)

• Liquidia challenges regulatory exclusivity for rival's inhaled drug (Reuters)
• Federal judge blocks noncompete ban, and FTC considers appeal (STAT)