Temporal Concept
J&J’s $130M gene therapy bet flunks rare retinal disease trial
Johnson & Johnson, gene therapy, bota-vec, X-linked retinitis pigmentosa, Phase 3 failure, vision loss treatment, rare eye disease, $130 million investment
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
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
Moderna expands effort to rein in costs in an uncertain environment
Moderna, Financial cost, Uncertainty, Environment
Novartis to buy Regulus Therapeutics for up to $1.7B
Goldcrest, Novartis, Acquisition (action), Kidney Diseases
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids
Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease
United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s