Recon: EU eyes new rules governing AI; Bluebird’s newly approved sickle cell gene therapy priced at $2.2M

• The prices of 8 drugs were hiked without proof of new benefits, costing the U.S. $1.2 billion in 2022, report finds (STAT)
• Weight loss from Lilly's Zepbound reversed after stopping treatment, study shows (Reuters)
• Moderna, Merck begin late-stage study for mRNA cancer therapy (Reuters)
• Cigna abandons pursuit of Humana, plans $10 billion share buyback (Reuters)
• Pfizer’s $5.4B GBT Bet Pays Off with Promising Phase II Data for Oxbryta Successor (BioSpace)

• Provisional Agreement Reached For EU Artificial Intelligence Act (MedTech Insight) (European Parliament)
• Time Pressures May Result In Diluted Global Pandemic Treaty (Pink Sheet)
• Eudamed Features High On MDCG’s December Meeting Agenda (MedTech Insight)
• Swedish regulator asks doctors not to prescribe diabetes drugs for weight loss (Reuters)
• As UK dental system decays, surging numbers seek treatment abroad (Reuters)
• Autoimmune patients in CAR-T study see striking improvements across lupus and other diseases (Endpoints)
• Hoba, a Danish biotech from Novo, raises $25M to crack into difficult pain and hearing loss fields (Endpoints)
• Global Pharma Guidance Tracker – November 2023 (Pink Sheet)
• Sanofi taps local drugmaker Minapharm to crank out popular blood thinner Clexane in Egypt (Fierce Pharma)

• Bluebird’s Newly Approved SCD Gene Therapy Faces Rough Road with Hefty Price Tag, Boxed Warning (BioSpace)
• After sickle-cell screwups, Bluebird Bio’s only option might be a company sale (STAT)
• The First Crispr Therapy Is Start of DNA-Editing Revolution (Bloomberg)
• US Generics Industry Group Gets New Board Chair, Begins Search For New CEO In Earnest (Pink Sheet)
• The biotech news you missed from the weekend (STAT)
• A Q&A with Vertex founder Joshua Boger on Casgevy, the biotech industry, and Elon Musk (STAT)
• After two historic approvals, Editas unveils promising early results for its sickle cell therapy: #ASH23 (Endpoints)
• Patients Regained Weight After Stopping Lilly Drug in Study (Bloomberg)
• Catalent details revenue downturn, staff cuts as it looks forward to a brighter 2024 (Endpoints)
• Roche partner touts early allogeneic CAR-T data at #ASH23, but durability remains key question (Endpoints)
• Novartis, on a roll with newly approved Fabhalta, touts its promise in another rare blood disease (Fierce Pharma)
• Novartis puts ‘Sopranos’ actor in TV spot for MS drug Kesimpta (Fierce Pharma)
• American Cancer Society boosts Big Pharma backed ‘Get Screened’ lung cancer campaign (Fierce Pharma)

• GE HealthCare CEO named chair of AdvaMed as device lobby forms new imaging division (STAT)
• Exclusive: Aviv Regev talks three years of leading Genentech’s research, the future of AI, and not making Nobel predictions (Endpoints)
• Medtronic expands AI endoscopy partnership with Cosmo (MedTech Dive)
• Hologic promotes Essex Mitchell to COO (MedTech Dive)

• Eli Lilly Won't Get Quick Exit From Mounjaro Injury Claims (Bloomberg)
• NEJM aims to hold AI to account with new publication (STAT)
• Novo Nordisk Must Face Suit From Woman Who Lost Teeth on Ozempic (Bloomberg)
• Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference (FDA Law Blog)