Recon: US to build $300M Alzheimer’s database; BioNTech, DualityBio partner to develop ADC drugs in $1.5B deal
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Ascendis’ shares slump 38% as FDA unexpectedly halts hypoparathyroidism drug review (Fierce) (MedWatch)
- Vertex and CRISPR Advance First-In-Kind Therapeutic for SCD (BioSpace) (STAT) (BioSpace)
- After Akorn's site closures in the US, albuterol remains in shortage (Endpoints)
- FDA Can Apply Faster Drug Withdrawal Powers Without New Guidance (Bloomberg)
- US House assembles bipartisan caucus on domestic pharma manufacturing (Endpoints)
- Amid SVB storm, pharma’s reputation bucks downward trend and scales up driven by insulin price drops (Fierce) (Endpoints)
- US to build $300 mln database to fuel Alzheimer’s research (Reuters)
- HHS Publishes National Cancer Plan in Collaboration With NIH (Bloomberg)
- ‘If we don’t, others will’: White House Covid adviser calls on doctors to combat a vacuum of medical information (STAT)
- The tragic, preventable reasons syphilis is surging among U.S. infants (Washington Post)
- Whoops: CMS quietly pares back list of drugs requiring new rebates under Inflation Reduction Act (Endpoints)
- Brains Shrink With Anti-Amyloid Alzheimer’s Drugs (MedPage Today)
- Medicare Expected to Become Insolvent by 2031, Trustees Say (MedPage Today)
- BioNTech, DualityBio to develop cancer treatment drugs in over $1.5-bln deal (Reuters) (Pharmaceutical Technology) (Fierce) (BioSpace) (Endpoints)
- After COVID and drug shortages, EU revamps drug laws (Reuters)
- EU Health Chief Under Pressure To Explain Delay In Legislative Overhaul (Pink Sheet)
- CHMP gives thumbs-up for Wegovy use in adolescents, along with nine new drug recommendations (Endpoints) (Pink Sheet)
- Bivalent COVID-19 Vaccine Bimervax Wins EU Marketing Approval (Pink Sheet)
- EU CHMP Opinions and MAA Updates (Pink Sheet)
- Syphilis cases in babies skyrocket in Canada amid healthcare failures (Reuters)
- New Powers For Australian Agency To Deal With Drug Shortages (Pink Sheet)
- Takeda pays $5M upfront to license antibodies for celiac disease drug development (Endpoints)
- Reeling from AstraZeneca’s termination of pneumonia collab, Aridis lays off 20% of staff (Fierce)
- Lilly says experimental Alzheimer’s drug reduces amyloid in small study (Reuters) (Fierce)
- US Biotech Firm Apellis Is Said to Attract Takeover Interest (Bloomberg)
- Gene therapy startup Vedere to close two years after launch (BioPharma Dive)
- Galapagos, following Sanofi’s playbook, offloads French R&D site to drug discovery CRO (Fierce)
- Call For Globally “Streamlined, Harmonized And Flexible Approach” To Real World Evidence (MedTech Intelligence)
- What The UK’s “Non-Statutory” AI Regulatory Framework Means For Medtech (MedTech Insight)
- FDA begins investigation of unauthorized dental device that sparked at least 20 lawsuits (Fierce) (MedTech Dive)
- Pixium Vision’s bionic eye implants nets FDA breakthrough label in drug AMD (Fierce)
- Abbott scores FDA green light for latest surgical aortic valve replacement implant (Fierce)
- Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says (MedTech Dive)
- Medtronic, DaVita launch kidney care joint venture (MedTech Dive)
- Dionysus Digital Health Hopes To Be First To Market With Blood Test To Forecast Postpartum Depression (MedTech Insight)
- In Teva vs. skinny label feud, Biden admin urges Supreme Court to weigh in (Fierce) (Endpoints)
- J&J Talc Unit Loses Bid to Pause Mandate Dismissing Bankruptcy (Bloomberg) (Fierce)
- FTC tells Illumina to divest Grail, boosting Icahn’s case (STAT)
- Mylan Beats Securities Class Action Over EpiPen, Generic Drugs (Bloomberg)
- Hip Implant Expert Cleared to Testify Over DePuy’s Objection (Bloomberg)
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