Recon: FDA expresses concern on sickle cell CRISPR therapy prior to adcomm; President Biden issues executive order on AI risks

• Coherus, Junshi Get FDA Approval for First Chinese PD-1 and NPC Treatment (BioSpace) (Endpoints)
• FDA has some safety concerns about CRISPR-based sickle cell treatment, documents show (STAT) (BioSpace)
• FDA Greenlights First Therapy for Rare Cancer of the Nasopharynx (BioSpace)
• Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short (Pink Sheet)
• UPDATE 2-FDA advises not to purchase certain eye drops due to infection risk (Reuters)
• Biden Targets Artificial Intelligence in Broad Regulation Order (Bloomberg) (The White House)
• Paying for Covid pills will soon shift to insurers (STAT)
• Pharmacy staff from CVS, Walgreens stores in US plan 3-day walkout (Reuters)
• AbbVie takes $2.1 billion charge on cancer drug ahead of US price negotiation (Reuters)
• Masimo prevails against Apple in USITC patent investigation (MedTech Dive)

• EMA Chief Backs Restructuring Plan & ‘Regulatory Sandbox’ Proposal (Pink Sheet)
• Merck KGaA widens work on 'DNA damage' drugs in deal with China's Hengrui (Reuters)
• Amplifon lowers profit forecast on weak European market, shares drop (Reuters)
• Australia: Easier & Faster Mechanisms To Drive Biosimilars Uptake (Pink Sheet)
• Cardiology And Biomarker Opportunities In Next Funding Round Of EU's IHI (MedTech Insight)

• What to know about Sarepta’s upcoming data on its Duchenne gene therapy (STAT)
• An exit interview with Bristol Myers Squibb CEO Giovanni Caforio (STAT)
• Pfizer RSV vaccine lags GSK’s as head-to-head competition underway (Reuters)
• GSK's cancer drug Jemperli meets overall survival goal in late-stage trial (Reuters)
• Reviva Pharma's schizophrenia drug succeeds in late-stage study (Reuters)
• Novartis drug candidate scores interim win in rare kidney disease trial (Reuters)
• Exclusive: Trailing Karuna, MapLight Therapeutics aims to improve schizophrenia, CNS drugs with $225M Series C (Endpoints)
• Viridian inks $185M financing, hires three Magenta executives as CEO Scott Myers exits (Endpoints)
• Lexeo Therapeutics pencils in $113M IPO for cardiac and Alzheimer's gene therapy readouts in 2024 (Endpoints)
• Vyne aims to raise $88M; Sanofi invests in gene therapy company; 4DMT addresses clinical hold (Endpoints)
• Deal flow influx: Abingworth's new $356M fund will help Big Pharma expand drug labels (Endpoints)

• Revvity cuts annual forecast on weak demand for diagnostics, contract research (Reuters)
• Edwards posts early look at tricuspid device, stoking Abbott rivalry ahead of FDA panel (MedTech Dive)
• Baxter’s Heather Knight talks combating sepsis — and how AI can help (MedTech Dive)
• United Therapeutics looks to hog bioengineered organ R&D with $91M Miromatrix buy (Fierce)
• Accuray lays off nearly 6% of radiotherapy workforce (MedTech Dive)
• GE HealthCare’s imaging AI will become ‘increasingly meaningful’ to growth: Moody’s (MedTech Dive)
• ResMed Lays Off 5% Of Work Force Amid Strong First-Quarter Results For Fiscal Year 2024 (MedTech Insight)

• CUNY Halts Investigation of Alzheimer’s Researcher (The New York Times)
• Bayer US Court Verdict Raises Prospect of More Roundup Pain (Bloomberg)
• AMA Not Required to Disclose Sources of GlaxoSmithKline Article (Bloomberg)
• Treasurer Folwell Calls on Novo Nordisk to Lower the Unfair Cost of Weight Loss Drugs (North Carolina Department of Treasurer)
• Virtual care options flood the market as retailers take telehealth mainstream (STAT)