Recon: AP report claims FDA faces backlog of 2,000 overdue inspections; Lykos CEO steps down after MDMA drug setback

• FDA has massive backlog of factory inspections as staffers leave for private sector jobs (AP)
• Lykos' longtime CEO to step down in latest shakeup after MDMA drug setback (Reuters)
• Eli Lilly partners with AI-focused Genetic Leap to develop RNA-based drugs (Reuters)
• Can amylin drugs best Wegovy and Zepbound? Companies bet on next big obesity target (STAT)
• Summit Therapeutics vs. Merck: Prepping for a big lung cancer study reveal (STAT)
• ZipBio launches using generative AI to make compact proteins (Endpoints)
• Johnson & Johnson adds $1.1 billion to proposed talc settlement (Reuters)
• Drug distributor McKesson forecasts Q2 profit below estimates (Reuters)

• Landmark Guidance For Curbing Antibiotic Pollution Considers Impact On Pricing & Supply (Pink Sheet)
• Eli Lilly signs manufacturing deal for rheumatoid arthritis drug in Africa (Reuters)
• European heart group recommends renal denervation for some patients (MedTech Dive)
• Medtech Warming Up To Benefits Of Australia’s Teletrials Initiative (MedTech Insight)
• Congo receives long-awaited mpox vaccine doses (Reuters)

• Fake Ozempic: How batch numbers help criminal groups spread dangerous weight loss drugs (Reuters)
• Lilly has more positive data on its weekly insulin (STAT)
• Alnylam versus BridgeBio: The ATTR-CM debate (STAT)
• US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization (Pink Sheet)
• Moderna’s mpox vaccine outperforms approved version in preclinical study (Endpoints)
• Novartis to spend $200 million in further bid to boost radiopharma manufacturing, market dominance (STAT)
• IN8bio pauses glioblastoma program, halves workforce as it prioritizes leukemia asset (Endpoints)
• MDLive veterans nab $7.5M Series A for virtual specialty care startup (Endpoints)
• Astellas to close facility in California; Takeda can make more of its ADHD drug (Endpoints)
• BioMarin restructures following staff shakeup, slow Roctavian sales (Endpoints)
• Higher dose of Spinraza helped spinal muscular atrophy patients, Biogen says (Endpoints)
• Diversity Action Plans: What To Submit And When (Endpoints)

• Court orders J&J to pay $1B following buyout of surgical robotics company (Endpoints)
• Abbott follows rival Dexcom with OTC glucose monitor launch in US (Reuters)
• AI still the most exciting emerging technology for healthcare: survey (MedTech Dive)
• Exact Sciences Looks Ahead As Cologuard Marks 10th Anniversary (MedTech Insight)
• Ultrasound Firm Sonio Acquired By Samsung Medison (MedTech Insight)

• Judge rules J&J owes Auris investors $1 billion related to 2019 robotics deal (Reuters)
• Walgreens hit with lawsuit claiming generic cold medicine has cancer-causing chemical (Reuters)
• Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal (Pink Sheet)
• Humana cutting Medicare Advantage plans that cover 10% of members (STAT)
• US pharmacy chain Rite Aid to operate as a private company as it emerges from bankruptcy (Reuters)
• Purdue Pharma gets extension for Sackler settlement talks (Reuters)