April 2025
Chinese CRO GemPharmatech expands in San Diego as industry weighs FDA’s animal testing shift
United States Food and Drug Administration, GemPharmatech, Contract Research Organization, San Diego, Animal Testing, mouse models, expansion, Industry
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
Stealth biotech bags rights to VelaVigo bispecific in $440M deal
VelaVigo, Antibodies, Bispecific, stealth, China
RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters
United States Food and Drug Administration, Does speak, Staff, negotiators, HHS, Mediation, user fee, Fees, Drug Industry
FDA moves to block biopharma employees from serving on advisory committees
United States Food and Drug Administration, Workers, Advisory Committees, Industry, Policy
Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss
orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables
UK approval brings GSK’s Blenrep back from the brink
UK, Approved, Multiple Myeloma, DREAMM-8, dexamethasone, Blenrep, Antibody-Drug Conjugates, Risk, Cessation of life
Sanofi pens $1.8B research deal for 2 bispecific antibodies aimed at autoimmune, immunology
Antibodies, Bispecific, Autoimmune, Inflammatory Bowel Diseases, sanofi, Earendil Labs, Immunology, Collaboration, development aspects
FDA clears its first prescription migraine app, from Click Therapeutics
United States Food and Drug Administration, CT-132, Migraine Disorders, Click Therapeutics, click, first
Leaked HHS budget signals $40B in cuts, assumes ACA subsidies expire
Budgets, HHS, Patient Protection and Affordable Care Act, Subsidies, Agencies, Leaked, Administration occupational activities, proposal – intent, assumes, Programs – Publication Format