Recon: EU eyes new rules governing AI; Bluebird’s newly approved sickle cell gene therapy priced at $2.2M
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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