Recon: Novo Nordisk to slash US list prices for Ozempic, Wegovy; BioMarin withdraws gene therapy Roctavian after failing to find buyer
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Novo Nordisk to Cut US List Prices for Ozempic, Wegovy by Up to 50% (The Wall Street Journal)
- US CDC vaccine panel to meet in March after February session scrapped (Reuters)
- Exclusive: South Carolina seeks non-CDC reinforcements to contain growing measles outbreak (Reuters)
- In earnings call, Hims CEO addresses scrutiny of GLP-1 compounding (STAT)
- New biotech Slate Medicines raises $130M for migraine drug from China (Endpoints)
- Hungary's Turbine raises $25M Series B to build virtual experiments (Endpoints)
- Pfizer buys China rights to Sciwind’s approved GLP-1 drug in metabolic push (Endpoints)
- Third Time Lucky? Vanda Awaits EMA Verdict On Iloperidone (Pink Sheet)
- EU’s 11% Clinical Trial Increase Goal Seen As ‘Absolute Minimum’ By Industry (Pink Sheet)
- Frontier Biotechnologies strikes up to $1 billion deal with GSK (Reuters)
- Bayer sues J&J over ‘false and misleading claims’ about competing prostate cancer treatments (STAT)
- Novo Nordisk’s triple-G is competitive with Lilly in obesity, but likely to be second to market (Endpoints)
- My biggest GLP-1 ethical problem: patients who don’t want to stop (STAT)
- EMA Decision Time For Single-Dose Sleeping Sickness Drug Acoziborole (Pink Sheet)
- New treatment approach could give IBD patients hope, and be a bonanza for drugmakers (STAT)
- Digital twins, the holy grail of preventative health, are still only a ‘Frankensteinian proof of principle’ (STAT)
- Failing to find a buyer, BioMarin pulls Roctavian in gene therapy's biggest disappointment (Endpoints)
- Patient dies in MacroGenics' cancer study, FDA puts trial on hold (Endpoints)
- Immedica wins accelerated approval for rare disease drug, plans to sell PRV (Endpoints)
- Abcuro plans to proceed with drug that failed pivotal muscle weakness trial (Endpoints)
- Indivior picks Havas to lead US marketing efforts as DTC push ramps up (Fierce Pharma)
- Medtronic’s MiniMed prices IPO at up to $784M (MedTech Dive)
- AdvaMed urges tailored tariff approach for medtech (MedTech Dive)
- Oura To Test Custom Large Language Model For Women’s Health (MedTech Insight)
- FDA Webinar Details Updates To Real-World Evidence Policy (MedTech Insight)
- Youth Alcohol Cravings May Rise While Scrolling Social Media, Study Suggests (MedPage Today)
- RFK Jr. Fought Pesticides for Years. Now He's Backing Their Production. (MedPage Today)
- Optum CMO: Doctors must take responsibility for patient outcomes (STAT)
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