Recon: FDA to increase inspections of Indian drugmakers; FDA rejects Minerva’s schizophrenia drug

• Oregon suspends a portion of its drug transparency law found to be unconstitutional (STAT)
• FDA protocols originally intended to be extra conservative are now heralded as evidence of mifepristone’s risk (STAT)
• Congress punts on PBM reform efforts (STAT)
• Experts say scale of Change cyberattack shows risk of centralized claims processing (STAT)
• IVF bans like Alabama’s could cost the lives of children already born (STAT)
• Internal documents shed new light on Sarepta FDA decision, which top agency official says was ‘exceptional’ (Endpoints)
• Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues (Fierce Pharma)
• US FDA to boost inspections of drug manufacturing units in India (Reuters)
• Minerva Neurosciences falls as US FDA declines to approve drug for schizophrenia symptoms (Reuters)

• UK biotech draws Pfizer backing in £40.5M Series A for peptide-inspired drugs (Endpoints)
• Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350 (Fierce Pharma)
• Australia's Noumed Pharma breaks ground on $65M manufacturing plant (Fierce Pharma)
• Japan's Takeda in regulatory talks to launch dengue vaccine in India (Reuters)
• New Zealand set to scrap world-first tobacco ban (Reuters)
• India court bars yoga guru's Patanjali from publishing some medicine ads (Reuters)
• European Council approves extension of IVDR transition (MedTech Dive)

• Drugmakers deepen efforts to tap into booming market for obesity drugs (Reuters)
• Viking Therapeutics obesity drug hits target in key study, raising hopes for a competitor to existing medicines (STAT)
• AstraZeneca bails on roxadustat’s future in the US, but keeps China pact with FibroGen (Endpoints)
• Janux shares up 90% as T cell engager shows early signs of PSA response in prostate cancer (Endpoints)
• Denali’s $500M placement; Brain health startup raises $26M (Endpoints)
• GV backs hair loss biotech out of UCLA with PhII set for mid-2024 (Endpoints)
• With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy (Fierce Pharma)
• Ex-VMLY&R leaders take top creative health jobs at new mega-agency VML (Fierce Pharma)
• Bristol Myers CEO says India to have largest R&D presence outside US by 2025 (Reuters)
• Zydus aims to launch first new drug in US by early 2026 (Reuters)

• Thermo Fisher downsized by 8,000 workers in 2023 amid revenue decline (Endpoints)
• Medtronic will transfer or offer comprehensive support to workers affected by ventilator exit (MedTech Dive)
• Agiliti to go private in $2.5B PE deal (MedTech Dive)
• ‘Deep Concerns’ Raised Over EHDS Regulation By Medtech Industry (MedTech Insight)

• Congress ditches site-neutral hospital pay policy (STAT)
• Private equity firm offers $5.8 billion buyout of hospital billing company R1 RCM (STAT)
• MD Anderson tried — and failed — to resolve research credit dispute between two scientists, new documents show (STAT)
• The quest for psychedelics in the Amazon would push a Harvard botanist to his limits (STAT)