Recon: FDA to increase inspections of Indian drugmakers; FDA rejects Minerva’s schizophrenia drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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