Recon: FDA approves drugs for persistent herpes, schizophrenia; Steris to buy Xodus Medical for $2.1B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves Asahi Kasei's drug for persistent herpes infections (Reuters) (The Pharma Letter)
- Teva wins FDA approval for monthly schizophrenia injection Weltruza (Reuters) (Fierce Pharma)
- FDA’s Rasonque review documents pressure RevMed as investors jitter over KRAS subgroup data (Fierce Pharma)
- FDA staff push back against Trump administration interim peptide dispensing order (Pink Sheet)
- New PDUFA deal allots money to rehire FDA reviewers, trade groups say (Endpoints)
- FDA staff bristle at opaque ‘calibration boards’ in new performance ratings push (Pink Sheet)
- CDC offers states $100 million in measles support as cases climb (New York Times)
- Merck’s Lipfendra: Speedy review followed months of FDA heavy lifting (Pink Sheet)
- Foreign clinical trial data: FDA draws a firmer line (The Pharma Letter)
- Cancer vaccines are the NIH’s next ‘big bet' (New York Times)
In Focus: International
- WHO unsure what caused pneumonia that killed plague-lab worker in Russia (Reuters)
- Valneva shrugs off UK Ixchiq withdrawal, other licenses worldwide unaffected (Pink Sheet)
- Colombian pharma groups sign alliance to fight counterfeit medicines (The Pharma Letter)
- EU will make standards free, faster and AI-ready after CJEU ruling (Medtech Insight)
- Results reporting to become a measure of EU’s clinical trials performance (Pink Sheet)
- What do new EU drug launch rules mean for patient access? (Pink Sheet)
- India GMP trends and lingering systemic failures: What the FDA, DCGI said (Pink Sheet)
- BioJapan: Policy changes key to rebuilding Japan’s competitiveness (Pink Sheet)
- German medtechs’ 10-point plan augurs ‘autumn of reform’ (Pink Sheet)
- MHRA AI rules get thumbs up from digital experts as UK builds ‘frictionless’ regulator (Medtech Insight)
Pharma & Biotech
- Steris doubles down on healthcare consumables with $2.1 billion Xodus buy (Reuters)
- Viatris to make $1.65 billion Pacira acquisition, adding to momentum in pain (Endpoints)
- AI startup Chai lands GSK deal, its sixth pharma partner in nine months (Endpoints)
- Bristol Myers' lung disease drug succeeds at lower dose in late-stage trial (Reuters) (Bloomberg)
- AstraZeneca blames trial design for phase 3 failure of bone disease drug (Endpoints)
- Endeavor notches major mid-stage trial win, says IPF drug can reverse disease (Endpoints)
- Zealand, Roche topline a phase 2 study for amylin drug, though Lilly remains an obstacle (Endpoints)
- Long ignored by drugmakers, preeclampsia is now a focus for WHO and biopharma (Endpoints)
- Quince relaunches as IRulya, going all in on lung disease after Hail Mary merger (Fierce Pharma)
- Parkinson's cell therapy biotech Aspen Neuroscience and I&I startup Bambusa file for IPOs (Endpoints)
Medtech
- FDA clears Motivista for schizophrenia’s negative symptoms, but coverage remains unsettled (Medtech Insight)
- Philips wins Dutch court battle with shareholders over recall (Reuters)
- Medtech lobby seeks broader device eligibility for CMS’ proposed RAPID pathway (MedTech Dive)
- AdvaMed urges copyright office to reject renewal of medical device repair exemption (Medtech Insight)
- CLIA proposal codifies existing remote flexibilities while adding new digital-data requirements (Medtech Insight)
- Medical Microinstruments raises $125 million in Series D to scale robotic microsurgery (Medtech Insight)
- Healthcare organizations are underprepared for quantum computing threats (MedTech Dive)
Food & Nutrition
- Renewed calls for UK allergen ratings after girl’s death (Food Safety News)
- With Cyclospora lettuce outbreak over, Taylor Farms speaks up as FDA is questioned (Food Safety Magazine)
Government & Legal
- Acting general counsel at HHS has left the department (Endpoints)
- GENEROUS Medicaid MFN pricing demo could extend beyond 2030, CMMI official says (Pink Sheet)
- New York and Pennsylvania's split screen approach to measles (Politico)
- Florida health officials meet amid fierce debate over childhood vaccine plans (Politico)
- Proposed US census changes could be catastrophic for public health (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.
