ENTITY – Page 6

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

2 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO

2 weeks ago talkbio0Tagged Appointments, biotech leadership, Cancer Therapeutic Procedure, CEO, Commissioner, Hahn, Nucleus RadioPharma, Radiopharmaceuticals, supply chain, United States Food and Drug Administration

Nucleus RadioPharma; Stephen Hahn; FDA Commissioner; CEO appointment; radiopharmaceuticals; cancer therapy; supply chain; biotech leadership

FDA Lifts Hold on Rocket Pharmaceuticals’ Pivotal Gene Therapy Study at Lower Dose

2 weeks ago talkbio0Tagged C3 complement inhibitor, Capillary Leak Syndrome, Dosage, gene therapy, Glycogen Storage Disease Type IIb, Individual Adjustment, Phase 2 Clinical Trials, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

FDA; Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; RP-A501; dose adjustment; C3 complement inhibitor; capillary leak syndrome; patient death; Phase II trial

American Academy of Pediatrics Breaks with RFK Jr., CDC on COVID Vaccines for Kids

2 weeks ago talkbio0Tagged Academy of Pediatrics, antiarrhythmic peptide, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Immunization, Pediatric brand name, Policy, public health guidance, Robert F. Kennedy, Vaccines

American Academy of Pediatrics; AAP; COVID-19 vaccine; children; CDC; Robert F. Kennedy Jr.; pediatric immunizations; public health guidance; vaccine policy

Draft MAHA Commission Report Outlines Broad Vaccine Framework and Addresses Childhood Chronic Disease

2 weeks ago talkbio0Tagged CDC, Centers for Disease Control and Prevention (U.S.), childhood vaccine schedule, Chronic disease, Commission, draft report, Drug Industry, MAHA, medical freedom, overmedicalization, vaccine framework, vaccine injuries

MAHA Commission; draft report; vaccine framework; childhood vaccine schedule; vaccine injuries; medical freedom; conflicts of interest; CDC; chronic disease; overmedicalization; pharmaceutical industry

Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns

2 weeks ago talkbio0Tagged Adverse event, aspects of adverse effects, Clinical Trials, Contraceptives, Oral, drug efficacy, gastrointestinal, Obesity, Stock Crash, Viking, VK2735, Weight Loss

Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy

Tariffs and MFN Policy Power a Broad, Confusing Pharma War

2 weeks ago talkbio0Tagged Drug Industry, drug manufacturing, Drug Prescriptions, Medicaid, MFN, Nation, onshoring, pharma innovation, Policy, Trump administration

tariffs; Most Favored Nation (MFN) policy; prescription drug pricing; pharmaceutical industry; Trump administration; drug manufacturing; onshoring; Medicaid; pharma innovation