May 2, 2025
FDA frees Amgen’s phase 1 obesity asset from clinical trial hold
Obesity, United States Food and Drug Administration, Amgen, MariTide, Study on Hold, Participant
FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth
Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback
Exact Sciences plans ‘transformative year’ with 3 cancer test debuts
Science, MRD, Exact brand biomedical or dental material, Hypersensitivity
FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
United States Food and Drug Administration, Allogeneic bone graft, Mycobacterium tuberculosis, guidances, Disease Outbreaks, standards characteristics
HHS to require all “new vaccines” to be tested against placebo
Vaccines, HHS, placebo-controlled trials, COVID19 (disease), Testing, Placebos, Policy
Tang’s Concentra snaps up Kronos in buying spree
Concentra, Acquisition (action), Kronos, Kronos Bio, Purchase
BMS to close Illinois site as part of cell therapy manufacturing consolidation
Bristol Myers Squibb, viral vector production, Libertyville Illinois, manufacturing consolidation, Novartis acquisition, cell therapy, cost cuts
Lilly’s Q1 revenue surge overshadowed by CVS dumping Zepbound for Wegovy
Chorionic Villi Sampling, Zepbound, Eli Lilly, Wegovy, Health
Generation Gold Standard: HHS’s $500 Million Initiative for Universal Vaccine Development
Universal vaccines, beta-propiolactone (BPL), whole-virus platform, influenza, coronavirus, NIH, Jay Bhattacharya, Robert F. Kennedy Jr., pandemic preparedness