Recon: US to build $300M Alzheimer’s database; BioNTech, DualityBio partner to develop ADC drugs in $1.5B deal

• 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)