Recon: AZ, Oracle partner for AI-powered clinical trials; FDA approves Haemonetics vascular closure system
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Antheia gets $80M conditional DOD loan to onshore to the US (Endpoints) (DOD)
- FDA approves immunotherapy Jemperli for new indication (The Pharma Letter) (FDA)
- FDA’s biologics center recruits former epidemiology office head to return (Pink Sheet)
- GSK’s Jemperli rectal cancer indication becomes FDA’s 11th national priority voucher approval (Pink Sheet)
- FDA to rare disease sponsors: Include patient voice from the start, not as an afterthought (Pink Sheet)
- Will FDA’s push for faster early-stage trials summon ghosts of COVID-19 vaccine hesitancy? (Pink Sheet)
- As weight-loss drug users turn to dietary supplements, doctors, regulators raise flags (Reuters)
- Haemonetics says FDA clears vascular closure device (Reuters)
In Focus: International
- MHRA authorizes Redemplo for familial chylomicronemia syndrome (The Pharma Letter)
- GLP-1 boom fuels dangerous black market for smuggled weight-loss drugs in Brazil (Bloomberg)
- Hims & Hers Health launches online weight management service for men in Germany (Reuters)
- ‘Very unusual:’ Aumseqa loses EU approval in first-of-its-kind data protection revocation (Pink Sheet)
- CTR ‘nightmares’ offer cautionary tale for EU pharma reform rollout (Pink Sheet)
- Omeros fails to rescue US-approved Yartemlea in EU with conditional approval gambit (Pink Sheet)
- China regulator’s PIONEER plan to adopt new approach methodologies (Pink Sheet)
- Nipro’s Stemirac set to earn Japan’s first full approval for a cell therapy (Pink Sheet)
- Brazil’s regulatory sandbox moves closer (Pink Sheet)
- J&J’s bedaquiline enters PRIME, but EMA may rename it to avoid confusion over scheme’s scope (Pink Sheet)
Pharma & Biotech
- AstraZeneca partners with Oracle for AI-driven clinical trials (Reuters) (Fierce Biotech)
- TriGemX plans $246 million SPAC deal to fund migraine program (The Pharma Letter) (Fierce Biotech)
- Ambrose Healthcare inks $181M deal for former Pfizer target AM-Pharma (Fierce Biotech)
- Drug developer Lycia Therapeutics targets $938 million valuation in US IPO (Reuters)
- AstraZeneca-Amgen asthma drug hits 69% remission in esophageal disease trial (Reuters)
- Rapport says drug it licensed from J&J clears phase 2 bipolar mania study (Endpoints) (Fierce Biotech)
- Pfizer makes ‘business decision’ to end phase 2 trial of autoimmune drug as program’s future uncertain (Fierce Biotech)
- Israeli biotech’s inhaled exosome therapy reduces respiratory failure in phase 2 study (Fierce Biotech)
- Astellas partners with Boston ‘miniproteins’ startup (Endpoints)
Medtech
- FDA clears Sequel’s insulin delivery system in Type 2 diabetes (MedTech Dive)
- MHRA will ‘routinely’ use AI and international reliance in assessments by 2030 (Medtech Insight)
- AdvaMed calls for tariff stability and faster device coverage at medtech conference (Medtech Insight)
- Growth investors want high unmet need and lower costs, not hot categories (Medtech Insight)
- Kimberly-Clark’s Kenvue buy clears EU review after agreeing to divest European tampon brands (Medtech Insight)
- Fractyl’s Revita clears first pivotal hurdle in post-GLP-1 weight maintenance; De Novo request next (Medtech Insight)
Food & Nutrition
- FDA steps up import enforcement because of Salmonella, pesticides, illegal colors (Food Safety News)
- More than two dozen patients identified in outbreak linked to oysters (Food Safety News)
Government & Legal
- California settles 23andMe data breach claims for $6 million (Reuters)
- The key health care ballot measures we’re watching in the midterms (STAT)
- Medicaid cuts haunt Republicans in battleground states (Politico)
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.
