Recon: FDA approves first two biosimilars to Regeneron’s Eylea; Neuralink cleared to implant brain chip in second patient
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves two biosimilars for blockbuster eye drug Eylea (Reuters)
- BIO to announce reorganization, senior leaders expected to depart (STAT)
- Elon Musk’s Neuralink Gets FDA Green Light for Second Patient, as First Describes His Emotional Journey (WSJ) (Reuters)
- Lobbying group BIO restructures staff in shakeup under new CEO (Endpoints)
- Bernie Sanders may have reached the limits of his pharma pressure campaign (STAT)
- Gilead's rare liver disease drug improves symptoms in another Phase 3 study ahead of FDA decision (Endpoints)
- Genetic profile may predict best response to weight-loss drug Wegovy (Reuters)
- US FDA approves Amgen drug for small cell lung cancer (Reuters)
- Americans divided as Supreme Court weighs abortion pill access, Reuters/Ipsos poll finds (Reuters)
- AstraZeneca earmarks $1.5B for end-to-end ADC factory in Singapore (Endpoints)
- UK's infected blood scandal could and should have been avoided, inquiry finds (Reuters)
- Shah Capital ends campaign against Novavax board after Sanofi deal (Reuters)
- Moderna wins COVID shot patent case against Pfizer-BioNTech in Europe (Reuters)
- EU regulator scraps approval for pregnancy drug over cancer risk (Reuters)
- Investors demand clarity from Fresenius over dialysis group FMC (Reuters)
- UK Life Sciences Cautiously Upbeat For Investment Year Ahead – BioWales 2024 (MedTech Insight)
- EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices (MedTech Insight)
- PDS Biotech’s survival benefit is absurdly overstated (STAT)
- Dyne Therapeutics sharpens case for two muscle disease therapies with updated data (Endpoints)
- Foghorn’s $110M offering; Novovax investor withdraws proxy campaign (Endpoints)
- WuXi Biologics pauses Massachusetts build; Novo Holdings nabs majority stake in pharma tools firm (Endpoints)
- Progentos emerges with $65M for multiple sclerosis trials with IP from Frequency (Endpoints)
- AstraZeneca, Amgen tout Phase 2a Tezspire data in COPD ahead of Dupixent decision (Endpoints)
- Mega startup watch; Interview with Siddhartha Mukherjee; Tracking Wegovy’s long-term effects; Biogen’s ALS flop; and more (Endpoints)
- Rapport, a clinical-stage neuroscience biotech, files for IPO (Endpoints)
- Jim Burns reunites with Genzyme colleague at Ensoma; Lilly exec to retire after 27 years (Endpoints)
- A novel spinal cord stimulator treats paralysis without surgery. FDA will rule on it soon (STAT)
- Pulsed field ablation poised for fast adoption, analysts say (MedTech Dive)
- J&J posts latest Varipulse data while awaiting FDA review (MedTech Dive)
- UK backs use of cancer treatment offered by Boston Scientific (MedTech Dive)
- FDA issues import alerts against 2 more plastic syringe manufacturers (MedTech Dive)
- FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device (MedTech Insight)
- Class action against UnitedHealth asks about DOJ probe transparency (STAT)
- Private equity escapes FTC in court, but anesthesia group doesn’t (STAT)
- Why health systems are faring better so far in 2024 (STAT)
- HHS’s proposed rule pays lip service to addressing the climate crisis, the greatest threat to human health (STAT)
- Health plan startup Centivo acquires primary care operator Eden Health (Endpoints)
- Upcoming EveryLife Foundation Scientific Workshop on May 21, 2024 will Address Challenges in Developing Therapies for Ultra-Rare Diseases (FDA Law Blog)
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