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11th January 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.