Recon: Vertex buys Crinetics for $10B; EMA fast tracks Revolution’s metastatic pancreatic cancer drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- US FDA approves Vera's kidney disease drug (Reuters)
- Vertex acquires Crinetics Pharmaceuticals for $10 billion as biotech M&A booms (STAT)
- Obesity biotech Kalohexis confidentially files to go public in US (Reuters)
- Almost $1 Billion Later, the US Still Can’t Make a Medical Glove (Bloomberg)
- Coming Soon: Proposed Rule to Remove “Adequate Provision” (and Ban DTC TV Ads?) (FDA Law Blog)
In Focus: International
- EMA fast-tracks review of Revolutions' experimental pancreatic cancer pill (Reuters)
- India finds Adani's Mumbai airport shops sold nicotine pouches in breach of law (Reuters)
- French gene therapy biotech gets €33M to follow Krystal's blueprint (Endpoints)
- EU Tests Drug-Diagnostic Partnerships In Unified Pathway Pilot (MedTech Insight)
- Ebola outbreak in Congo still spreading, WHO says (Reuters)
Pharma & Biotech
- Novartis, Vertex and Ipsen extend pharma's M&A spree after 45 first-half acquisitions (Endpoints)
- Online GLP-1 prescriptions are often fast, easy — and low on clinical oversight (STAT)
- Island Pharma Jumps 47% After Initial Approval for Ebola Drug (Bloomberg)
- Tanabe to sell manufacturing unit, rights to 17 meds to Towa (Fierce Pharma)
- AI care partner Heidi puts a spin on pharma ad tropes in new campaign to relieve 'side effects' (Fierce Pharma)
Medtech
- Alcon Bets Up To $200m On Tunable IOLs In RxSight Collaboration (MedTech Insight)
- $4bn Allograft Billing Scheme Leads Wound Care Focus In DOJ’s 2026 Fraud Takedown (MedTech Insight)
- Trio Of FDA Warning Letters Cites Poor Complaint Processing And Marketing Unauthorized Devices (MedTech Insight)
- Heavy Metals in Tampons Aren’t Cause for Concern, Regulators Say (Bloomberg)
Food & Nutrition
- McCormick gets $28M tariff refund as Iran war raises costs (Food Dive)
- Sara Lee owner to remove artificial preservatives from top brands (Food Dive)
Government, Regulatory & Legal
- 5 takeaways from STAT’s series on the soaring cost of health insurance (STAT)
- This whistleblower took on a health insurance giant and a political machine. She’s not stopping there (STAT)
- UnitedHealth Defends Home Visits in Latest Transparency Report (Bloomberg)
- How digital health companies are planning to conquer a brand new Medicare experiment (Endpoints)
- Obamacare rolls shrank dramatically in many states over the past year, new federal data shows (STAT)
- US makes available $281 mln in grants for addiction and mental health programs (Reuters)
- Conquering Medicare's ACCESS program (Endpoints)
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.
