Recon: Novartis, Matchpoint sign $1B deal to develop anti-inflammatory drugs; FDA reinstated a quarter of jobs cut by DOGE, Makary says
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA reinstated roughly a quarter of initial DOGE job cuts (Politico Pro)
- HHS Secretary RFK Jr. accepts recommendations to drop thimerosal from U.S. flu vaccines (STAT)
- Alnylam CEO: Congress must pass the MINI Act to protect future biotech breakthroughs (STAT)
- Medical groups and US states work to circumvent Kennedy's vaccine decisions (Reuters)
- Exclusive: Sarepta would have to conduct new studies to get back on market, FDA official says (Endpoints)
- FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies (CNN)
- FDA panel on the use of antidepressants during pregnancy is alarming experts (LA Times)
- Do fluoride supplements harm children? FDA panel discussion turns into heated debate (NBC) (CNN)
- Novartis to pay Matchpoint up to $1 billion to develop anti-inflammatory therapies (Reuters)
- Permira, Nordic in Takeover Talks for Vaccine Maker Bavarian (Bloomberg) (Reuters)
- Weak regulation causing deaths due to contaminated medicines, WHO says (Reuters)
- TCG Labs Soleil gets another $400M for single-asset biotechs, expands to China (Endpoints)
- Medtronic receives Type 2 label expansion for MiniMed 780G in Europe (MedTech Dive)
- Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation (MedTech Insight)
- Roche pauses shipments of Elevidys gene therapy outside US (Reuters)
- Why Sarepta may not survive its current gene therapy crisis (STAT)
- Contract research firms' strong earnings signal stabilizing biotech, pharma spending (Reuters)
- Political or professional? Makary's overhaul of CDER, CBER may reshape leadership norms (Endpoints)
- Roche profit beats forecast on strong sales of cancer, allergy drugs (Reuters)
- Roche May Sell Drugs Directly in US to Bypass Middlemen (Bloomberg)
- Sun Pharma to Settle US Generics Pricing Case for $200 Million (Bloomberg)
- AstraZeneca’s Autoimmune Medicine Reduced Disease Severity (Bloomberg)
- Sarepta's licensing partner Arrowhead expects near-term payments despite setbacks (Reuters)
- Rocket cuts 30% of staff as it plots path forward for gene therapies (Endpoints)
- Still in flux, Galapagos hires new execs, adjusts deal with Gilead, and considers selling its cell therapy business (Endpoints)
- Novo Nordisk to discontinue three insulin products; Thermo Fisher CFO to retire (Endpoints)
- LEO Pharma’s eczema cream is approved in the US; Abivax’s $650M offering (Endpoints)
- 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline (Fierce Pharma)
- FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice (Fierce Pharma)
- Labcorp to buy some Community Health assets for $195M (MedTech Dive)
- Boston Scientific halves expected tariff hit (MedTech Dive)
- Intuitive Surgical tempers tariff impact expectations (MedTech Dive)
- Baxter recalls certain Novum pumps over issues tied to 79 injuries, 2 deaths (MedTech Dive)
- Medtech M&A Resurges: How To Define Startup Exit Strategy (MedTech Insight)
- ForSight Sets Its Sights On Automating Delicate Eye Procedures (MedTech Insight)
- HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods (HHS)
- Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out (FDA Law Blog)
- How GLP-1 weight loss drugs are reshaping the food industry (Food Dive)
- UnitedHealth confirms DOJ investigations into Medicare practices, says it’s cooperating (STAT)
- How states can mitigate Trump’s Medicaid cuts – and set their health care systems on a better path (STAT)
- Molina Drops After Lowering Guidance Twice in One Month (Bloomberg)
- Missouri accuses Planned Parenthood of downplaying abortion drug risks (Reuters)
- 10M people will lose insurance due to GOP policy law: CBO (MedTech Dive)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
