Recon: FDA rejects Replimune’s oncolytic virus drug over study issues; Sarepta to halt shipments of Duchenne gene therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Drugmakers are racing to help patients stay awake — and could also make billions (STAT)
- Study of GLP-1 guidelines for teens points to potential for influence from drugmakers (STAT)
- In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy (STAT) (Reuters)
- US begins organ-transplant reform as 'signs of life' found before some retrievals (Reuters)
- AstraZeneca unveils $50 billion US investment as pharma tariff threat looms (Reuters)
- NIH Budget Cuts Are a Setback for American Science (Bloomberg)
- RFK Jr. Turns to Fringe Medical Journal to Find New Hires (Bloomberg)
- France's Sanofi to acquire biotech firm Vicebio for $1.15 billion (Reuters)
- CapVest eyes majority stake in German drugmaker Stada, Bloomberg News reports (Reuters)
- EU approves €403 mln in funding for companies to boost medical device innovation (Reuters)
- Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition (MedTech Insight)
- Expert Panels Remain Tough On Manufacturers And Their Notified Bodies (MedTech Insight)
- World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings (Pink Sheet)
- Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS (Pink Sheet)
- China’s Top Medical Device Maker Mindray Is Said to Mull Hong Kong Listing (Bloomberg)
- A rare drug trial for long Covid failed, yielding lessons on study design (STAT)
- US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy (Pink Sheet)
- Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance (STAT)
- Exclusive: Circular RNA startup Orbital unveils first monkey data as it enters in vivo CAR-T cell therapy race (Endpoints)
- Scancell’s skin cancer vaccines show Phase 2 promise but only one set to advance (Endpoints)
- Avalyn gets $100M to test inhaled pulmonary fibrosis medicines (Endpoints)
- Oscar Health Sees 2025 Loss as Obamacare Troubles Spread (Bloomberg)
- Slingshot AI, the a16z-backed mental health startup, launches a therapy chatbot (STAT)
- Trump delays ethylene oxide emissions standards for device sterilizers (MedTech Dive)
- HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing (MedTech Insight)
- FDA Document Request Denied As Case Against SurModics Merger Intensifies (MedTech Insight)
- Philip Morris Slumps After Zyn Shipments Miss Estimates (Bloomberg)
- Coca-Cola Says US Cane Sugar Soda Is Coming After Trump Post (Bloomberg)
- Pepsi to introduce prebiotic soda (Food Business News)
- IQVIA beats quarterly estimates on resilient demand for healthcare analytics (Reuters)
- A SPAC seeks $500M IPO to make drugs in the US (Endpoints)
- Humana refiles Medicare Advantage ratings lawsuit against federal government (STAT)
- Pioneer HIV researcher Robert Gallo: Cuts to medical research funding leave us vulnerable to viral threats (STAT)
- Humana to reduce about one-third of prior authorization requirements (Reuters)
- Medicaid enrollment startup Fortuna Health raises $18M (Endpoints)
- ‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents (Pink Sheet)
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