Quantitative Concept – Page 2

FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD

7 days ago talkbio0Tagged Age related macular degeneration, Diabetic Retinopathy, dosing, Extension, Eylea HD, Interval, Regeneron, Rejection, United States Food and Drug Administration

United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy

RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters

1 week ago talkbio0Tagged Does speak, Drug Industry, Fees, HHS, Mediation, negotiators, Staff, United States Food and Drug Administration, user fee

United States Food and Drug Administration, Does speak, Staff, negotiators, HHS, Mediation, user fee, Fees, Drug Industry

UK approval brings GSK’s Blenrep back from the brink

1 week ago talkbio0Tagged Antibody-Drug Conjugates, Approved, Blenrep, Cessation of life, dexamethasone, DREAMM-8, Multiple Myeloma, Risk, UK

UK, Approved, Multiple Myeloma, DREAMM-8, dexamethasone, Blenrep, Antibody-Drug Conjugates, Risk, Cessation of life

Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss

1 week ago talkbio0Tagged Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Hemoglobin A1c measurement, Injectables, Oral cavity, orforglipron, Phase 3 Clinical Trials, Safety, 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

Leaked HHS budget signals $40B in cuts, assumes ACA subsidies expire

2 weeks ago talkbio0Tagged Administration occupational activities, Agencies, assumes, Budgets, HHS, Leaked, Patient Protection and Affordable Care Act, Programs - Publication Format, proposal - intent, Subsidies

Budgets, HHS, Patient Protection and Affordable Care Act, Subsidies, Agencies, Leaked, Administration occupational activities, proposal – intent, assumes, Programs – Publication Format

RFK Jr. attacks environmental toxins as cause of childhood autism ‘epidemic’, stays silent on vaccines

2 weeks ago talkbio0Tagged Autistic Disorder, Environment, HHS, Kennedy, RFK gene, Vaccines

Autistic Disorder, Vaccines, Kennedy, Environment, RFK gene, HHS

Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg

2 weeks ago talkbio0Tagged Alarm device, Changing, Disease Outbreaks, drug safety, Icebergs, KAT5 wt Allele, Leadership, Policy, Previous, public health medicine (field), United States Food and Drug Administration, Vaccines, Visible

United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible

UPDATE: With looming Trump tariffs, pharma companies demand changes to stay in EU

2 weeks ago talkbio0Tagged drug price, EU, Industry, Investments, Pharma, Policy, Transplant Registry Unified Management Program, United States

EU, Pharma, Industry, Transplant Registry Unified Management Program, Policy, Investments, United States, drug price

Pharma’s wins and losses in Trump’s sprawling executive order on drug prices

2 weeks ago talkbio0Tagged drug price, Industry, Insulin, IRA, losses, Mediation, Medicare, Prices, small molecule drugs

Medicare, Medicare, Industry, drug price, Mediation, small molecule drugs, losses, IRA, Insulin, Prices

CDC advisors broaden RSV vaccine recommendations to at-risk adults in their 50s

2 weeks ago talkbio0Tagged 50–59, Adult, Age, Arexvy, broaden, Centers for Disease Control and Prevention (U.S.), Chronic Condition, Recommendation, Respiratory syncytial virus, Severe (severity modifier), Vaccines

Adult, Respiratory syncytial virus, Centers for Disease Control and Prevention (U.S.), Vaccines, Recommendation, Age, Arexvy, Chronic Condition, Severe (severity modifier), 50–59, broaden