Recon: FDA approves higher dose of Regeneron’s Eylea; Gilead’s blood cancer drug trials placed on hold
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves higher dose of Regeneron's eye disease drug Eylea (Reuters)
- Regeneron's Eylea could return to growth after nod to high-dose version- analysts (Reuters)
- As the obesity drug market grows, digital health companies juggle patients and payers (STAT)
- Biden administration to urge Americans get new COVID-19 boosters (Reuters)
- US FDA puts Gilead Sciences blood cancer drug studies on hold (Reuters)
- Eris, BA.2.86: Do I need to worry about COVID again? (Reuters)
- Johnson & Johnson to keep a 9.5% stake in consumer health spinoff Kenvue stake after exchange offer (Fierce Pharma)
- Roche, Exelixis' Tecentriq-Cabometyx combo rebounds with partial win in previously treated prostate cancer (Fierce Pharma)
- Merck's Keytruda will top pharma's sales rankings in 2028, with Roche taking the company category crown: Evaluate (Fierce Pharma)
- FDA Pilot Program for Cancer Diagnostics Met with Skepticism (BioSpace)
- Novartis plans Sandoz spin-off around Oct. 4, proposes share distribution (Reuters)
- Berlusconi Office Backs $100 Million Pharma Startup Qualifyze (Bloomberg)
- Japan health ministry panel recommends approval of Alzheimer's treatment Leqembi (Reuters)
- Notified Bodies Warn Manufacturers And Decision-Makers Not To Sabotage MDR Implementation (MedTech Insight)
- The Ozempic Craze Could Put These Companies on a Crash Diet (The Wall Street Journal)
- Google Parent’s Cost Cuts Hit Verily as Other Bets Group Feels Pressure to Stem Losses (The Wall Street Journal)
- An innovative eye stem cell transplant could help restore vision in people with chemical injuries (STAT)
- NewLimit's Jacob Kimmel brings anti-aging back to reality (Endpoints)
- Andreessen Horowitz-backed startup lands $200M for AI-based drug discovery (Endpoints)
- After Prometheus sale, Mark McKenna heads to another autoimmune biotech as chair of Apogee (Endpoints)
- Leo Pharma spending $14M upfront to acquire Timber (Endpoints)
- Moderna and CARsgen team up on CAR-T cell therapy and mRNA cancer vaccine combo (Endpoints)
- Skye acquires Bird Rock Bio, weeks after Novo Nordisk says it will buy a CB1 developer (Endpoints)
- Bruker to buy PhenomeX and its cell research tools for $108M (MedTech Dive)
- CRISPR Shows Preclinical Promise in Treating Alzheimer’s, Challenges Persist (BioSpace)
- Merck’s Welireg Clears Phase III Primary Endpoint in Renal Cell Carcinoma (BioSpace)
- Kodiak CMO Steps Down After Phase III Flops for Eye Therapy (BioSpace)
- Should Pharma Firms Cover CDx Costs For Precision Cancer Drugs? (Pink Sheet)
- What the hospital-at-home movement tells us about igniting innovation in health care (STAT)
- US FDA staff raise no concerns about Otsuka, Medtronic blood pressure devices (Reuters)
- Generative AI in healthcare: Google Cloud’s Amy Waldron on the tech giant’s health ambitions (MedTech Dive)
- Google expands AI mammography deal with iCAD (MedTech Dive)
- GaitBetter On Mission To Bring VR, AI-Based Solution To Gait Training; Will Physical Therapists Pay For It? (MedTech Insight)
- Recalls For Datascope And Abiomed Designated Class I (MedTech Insight)
- Indivior to pay $30 million to settle health plans' Suboxone claims (Reuters)
- Boehringer latest to sue US over drug price negotiation plan (Reuters)
- Bristol-Myers, J&J Likely First for Medicare Price Negotiation (Bloomberg)
- Ex-employees of Ramaswamy's investment company sue, claiming they were misled or pushed to violate securities law (Endpoints)
- AARP joins Justice Department's bid to knock down industry lawsuit targeting IRA pricing negotiations (Fierce Pharma)
- Relying On Perfection In An Imperfect World: ADHD Drug Shortage Could Spur Push For DEA Reform (Pink Sheet)
- New Workload Categories Add To FDA Staff Needs, Help Increase User Fees (Pink Sheet)
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