Recon: Pfizer to acquire obesity drugmaker Metsera for $4.9B; Bristol Myers to launch schizophrenia therapy Cobenfy in UK at U.S. price
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Federal vaccine adviser says former CDC officials can’t be trusted unless they agree to ‘public debate’ (STAT)
- Winner of mRNA Nobel Prize says ACIP member’s claim that Covid vaccines persist is ‘absolutely impossible’ (STAT)
- Walmart Adds Home Delivery for Ozempic, Other Refrigerated Drugs (Bloomberg)
- US Weighs Trump-Branded Website to Help Shop for Cheaper Drugs (Bloomberg)
- Birth Control Among US Therapies Most At Risk From Trump’s 250% Tariff Threat (Bloomberg)
- Novartis Working on Price Cut Proposals for US, CEO tells NZZ (Bloomberg)
- Trump expected to link autism with Tylenol, a claim highly disputed (Reuters)
- Big Pharma Forces Britain to Take Its Medicine (Bloomberg)
- Bristol Myers to launch schizophrenia drug in the UK at the same price as in the US (Endpoints)
- Avenzo collects another $60M for two small molecules and two ADCs licensed from China (Endpoints)
- Urgent support needed to prevent Ebola spreading in Congo, says Red Cross federation (Reuters)
- ShiraTronics Targets FDA Approval for Migraine Implant In 2027, Australian Review to Follow (MedTech Insight)
- MBX hormone replacement shows efficacy in mid-stage study (STAT)
- Pfizer to buy obesity-focused Metsera in $4.9 billion deal (STAT)
- Ionis says RNA drug for rare brain disorder succeeded pivotal trial, plans to ask for FDA approval (Endpoints)
- FDA approves Stealth's rare disease drug after past rejection, delay (Endpoints)
- Roche declares Phase 3 win for SERD in broad breast cancer population that eluded competitors (Endpoints)
- Zealand Pharma may sell future obesity drug direct to patients (Reuters)
- J&J pads Tremfya IBD offerings with subQ ulcerative colitis nod (Fierce Pharma)
- As medical AI use grows, industry payments to providers remain opaque (STAT)
- How SS Innovations is expanding robotic surgery’s reach (MedTech Dive)
- Ten Words We Won’t Miss: FDA Publishes Final Rule Implementing Court Vacatur of LDT Rule (FDA Law Blog)
- Medtronic wins FDA approval for urinary incontinence device (MedTech Dive)
- Exactech agrees to $8M settlement over defective knee implants (MedTech Dive)
- Trump administration halts government hunger report (The Hill)
- FDA proposes ban on rarely used Orange B food dye (Food Dive)
- Hospitals get dinged for reporting too many infections. In some cases, the solution is not to test (STAT)
- Most doctors believe interactions with pharma erode public trust, analysis finds (STAT)
- Don’t Wait! Early Talks With Device Innovators Pay Off, Say Australia, Malaysia Regulators (MedTech Insight)
- Trump’s health and the medicalization of American politics (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.