Recon: FDA again uncovers quality problems at Eli Lilly’s New Jersey site; Viatris considering $3B sale of its consumer drug division
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- U.S. finds new quality problems at Lilly drug factory (Reuters) (Fierce) (Endpoints)
- CDER strikes back at Vanda, discloses rationale behind 2019 sNDA rejection (Endpoints) (Pink Sheet)
- FDA spurns Supernus for Parkinson's drug, noting application issues 'across several areas' (Endpoints)
- After a rocky few months, Gilead’s Trodelvy keeps recent winning streak rolling with priority review (Fierce)
- US FDA’s New Chief Medical Officer Is Tackling Califf’s Top Priorities (Pink Sheet)
- Senate Republicans seek to repeal new government drug price negotiations (Endpoints) (FDAnews)
- NIH awards $15M contract to Intravacc’s nasal gonorrhea vaccine (Fierce)
- FDA Vapor Regulations Caught in Balancing Act With Youth Survey (Bloomberg)
- U.S. preventive health group recommends anxiety screening for kids 8 to 18 (STAT) (Reuters)
- Maternity care ‘deserts’ on the rise across the U.S., report finds (STAT)
- EU Moment of Truth For Abaloparatide & Advanced Therapy Tab-Cel (Pink Sheet)
- Pfizer exec denies vaccine negotiations via text message in grilling before European Parliament (Endpoints)
- Mirum Awaits EMA Verdict On ‘Reprioritized’ Livmarli Filing (Pink Sheet)
- Can First Approval Of China mRNA Vaccine Change 'COVID Zero' Approach? (Scrip)
- China steps up anti-COVID measures ion megacities as infections mount (Reuters)
- UN spokesperson: 16 confirmed cholera deaths in Haiti (Reuters)
- Viatris Considers Sale of $3 Billion European OTC Assets (Bloomberg) (Fierce) (StreetInsider)
- BIO Taps King as Interim CEO after McMurry-Heath Ousting (BioSpace)
- Eli Lilly tasks Nimbus with hitting a 'high-value' target for diabetes, obesity (Endpoints)
- Sandoz Weighs In On US Adderall Shortages Amid Supply Disruption (Generics Bulletin)
- Illumina continues trek into drug discovery, inks AI pact with AstraZeneca (Endpoints)
- Sanofi and Regeneron present more positive data for Dupixent product (Reuters)
- Rigel steps back from sNDA filing plans for bleeding disorder drug; NMD gives first look into troubled myasthenia gravis program (Endpoints)
- Are incentives necessary to achieve trial diversity? Two researchers say yes (Endpoints)
- AstraZeneca’s Nasal Spray for Covid Fizzles in Early Test (Bloomberg)
- PureTech and Nektar Call Off Rumored Merger (Biospace)
- Chasing Big Pharma rivals, NMD posts clinical data on rare disease prospect (Fierce)
- Ginkgo inks $144M deal with Merck to engineer enzymes to improve ingredient manufacturing (Endpoints)
- Neumora Raises Additional $112M to Advance Neuro Pipeline (BioSpace)
- BMS-backed Immatics’ cell therapy shows early promise in small data set, prompting $110M offering (Fierce)
- Eisai cuts the ribbon on $69M injectable drug delivery facility (Fierce)
- Medical Devices to Enter FDA Pilot Program Starting in 2023 (Bloomberg)
- Germany's Upper House Adds Weight To Urgent Calls To Address EU MDR/IVDR Issues (MedTech Insight)
- UK Medtech’s Wait-And-See Approach On New Ministerial Health Team (MedTech Insight)
- Expert: New Guidance May Demand Clinical Decision Support Software Re-Evaluation (MedTech Insight)
- Orthofix, SeaSpine to combine into $700M orthopedics player in merger of equals (Fierce)
- Cardinal Health Opioid Derivative Suit Ends With Settlement Nod (Bloomberg)
- New Abortion Bans Put on Hold by Courts in Arizona and Ohio (Bloomberg)
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