Recon: FDA rejects Replimune’s oncolytic virus drug over study issues; Sarepta to halt shipments of Duchenne gene therapy

• 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)