Recon: Emergent wins $235.8M US anthrax vaccine contract; FDA allows import of syphilis drugs from France amid shortage
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Courts will decide the future of Medicare’s power to negotiate drug prices within months (STAT)
- Emergent nabs US government contract of up to $235.8M for anthrax vaccine (Endpoints)
- FDA approves import of French antibiotics to combat syphilis drug shortage (Endpoints)
- Cigna CEO says the insurance giant is paying attention to healthcare services to buy: #JPM24 (Endpoints)
- FDA finds no evidence yet linking weight-loss drugs to suicidal thoughts (Reuters)
- Contributors to psychiatry’s bible, the DSM-5, got $14 million from industry (STAT)
- RTW, Bayer back Cytokinetics-allied Ji Xing Pharmaceuticals with $162M: #JPM24 (Endpoints)
- UK sequencing study surfaces new findings about tumor DNA (STAT)
- BioNTech pays $20M upfront for two monoclonal antibodies from China's WuXi Biologics (Endpoints)
- Nearly 1 in 10 teens globally have used ‘budget Ozempic’ laxatives and other risky weight loss products, per study (STAT)
- Oxford starts human testing of Nipah virus vaccine (Reuters)
- Pakistan seizes poisonous solvent used in cough syrup (Reuters)
- Early Version Of EU’s Medtech Dashboard Promises To Reflect A Regulatory Data Goldmine (MedTech Insight)
- UK MHRA Sets Out 2024-25 Regulatory Timetable And Multiple Statutory Instruments (MedTech Insight)
- EU AI Act Regulatory Overlap “Likely To Persist”: Expert Presents Solutions For Dual Conformity (MedTech Insight)
- At JPM, Verve details plot to take genome editing mainstream (STAT)
- Greg Verdine’s LifeMine eyes the clinic next year with T-cell immunosuppressive and antifungal: #JPM24 (Endpoints)
- Case against Gilead for delaying release of safer HIV drug on solid ground, court rules (Endpoints)
- Madrigal says it's 'well on the way' to potential NASH launch ahead of FDA decision: #JPM24 (Endpoints)
- WuXi Bio expands US presence; FujiFilm boosts autoinjector services; SpectronRx to make prostate cancer radioligand (Endpoints)
- Praxis prices $150M public stock offering ahead of four topline neuro readouts in 2024 (Endpoints)
- Dermavant's PhIII eczema data; Oxford's Nipah vaccine; Inventiva's €25M lifeline (Endpoints)
- Drugmakers plot way into obesity market with deals and development (Reuters)
- AbbVie expects Botox to maintain market share as competition heats up (Reuters)
- Novo CEO expects patients to stay on Wegovy longer than older weight loss drugs (Reuters)
- Accolade beats analyst estimates, Teladoc’s optimism, and more JPM health tech news (STAT)
- Patients’ social needs often get lost in health records. Generative AI could help (STAT)
- FDA adds vaporized hydrogen peroxide as sterilization alternative to EtO (MedTech Dive)
- Nevro laying off 63 people to strengthen financial position (MedTech Dive)
- Abbott CEO talks diabetes market, device pricing at J.P. Morgan conference (MedTech Dive)
- Livanova to close loss-making circulatory support business (MedTech Dive)
- J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice (MedTech Dive)
- Software Glitch Behind Recalled App Could Drastically Increase Insulin Delivery (MedTech Insight)
- JPM 2024: Illumina Publishes Results And Speaks On Future Efforts Towards Stabilization (MedTech Insight)
- How to ensure the NIH’s decision to recognize people with disabilities as a health disparity population makes a difference (STAT)
- Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration (FDA Law Blog)
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