ORG – Page 6 – Talk Bio

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

1 week ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

UK Pharma Trade Group Calls for Overhaul of Government’s Life Sciences Investment Evaluation and Medicines Pricing Schemes

1 week ago talkbio0Tagged ABPI, Biological Science Disciplines, Evaluation, government review, innovation, Investments, Nance-Horan syndrome, pharma trade group, Pricing, statutory scheme, UK, valproic acid glucuronide

UK life sciences; ABPI; VPAG; pharma trade group; investment evaluation; medicines pricing; government review; NHS; innovation; statutory scheme

Ionis Builds Case for Wider Tryngolza Use in Severe Lipid Disorders Following Positive Phase 3 Results

1 week ago talkbio0Tagged drug indication, expansion, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Lipid Metabolism Disorders, Olezarsen, Pancreatitis, Acute, Severe (severity modifier), TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; severe hypertriglyceridemia; lipid disorder; Phase 3 trial; familial chylomicronemia syndrome; acute pancreatitis; FDA; drug indication expansion

Amgen to Invest Over $600M in New Innovation Centre at California Headquarters

1 week ago talkbio0Tagged amgen, Automation, Biotechnology, California, Capital, Construction worker, digital tools, ELAVL2 gene, Incentives, innovation, innovation centre, Investments, Science, therapeutic development, Thousand Oaks

Amgen; innovation centre; science and innovation hub; Thousand Oaks; California; biotechnology; construction; automation; digital tools; therapeutic development; tax incentives; capital investment

Merck’s Oral PCSK9 Inhibitor Enlicitide Decanoate Achieves Third Consecutive Phase 3 Success

1 week ago talkbio0Tagged Administration of prophylactic statin, Clinical Trials, CORALreef Lipids, enlicitide decanoate, Hypercholesterolemia, LDL Cholesterol Lipoproteins, Merck, Oral cavity, oral PCSK9, PCSK9 inhibitor

Merck; oral PCSK9 inhibitor; enlicitide decanoate; Phase 3 trials; CORALreef Lipids; hypercholesterolemia; lowering LDL cholesterol; statin therapy; first oral PCSK9; clinical trial results

Novartis Takes Another Shot at Alpha-Synuclein With $2.2B Arrowhead CNS Deal

1 week ago talkbio0Tagged alpha-Synuclein, ARO-SNCA, Arrowhead Pharmaceuticals, biotech partnerships, Gene Silencing, Nerve Degeneration, Novartis, Parkinson 's disease, RNA Interference, TRiM platform

Novartis; Arrowhead Pharmaceuticals; alpha-synuclein; Parkinson’s disease; RNA interference (RNAi); gene silencing; ARO-SNCA; TRiM platform; neurodegeneration; biotech partnerships

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

1 week ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

1 week ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

Sanofi’s Wayrilz Receives FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

1 week ago talkbio0Tagged Approved, Autoimmune thrombocytopenia, BTK inhibitor, Inosine Triphosphate, LUNA 3 trial, Rilzabrutinib, sanofi, United States Food and Drug Administration, Wayrilz

Wayrilz; rilzabrutinib; FDA approval; immune thrombocytopenia; ITP; BTK inhibitor; Sanofi; LUNA 3 trial

Servier Pays $210M Upfront for Ex-US Rights to Ideaya’s PKC Inhibitor Darovasertib

1 week ago talkbio0Tagged Clinical Trials, Darovasertib, Ideaya Biosciences, Inhibitor, milestone payments, oncology licensing deal, Protein Kinase C, Protein Kinase C Inhibitor, royalties, Servier, uveal melanoma

Servier; Ideaya Biosciences; darovasertib; protein kinase C inhibitor; PKC inhibitor; uveal melanoma; oncology licensing deal; clinical trials; milestone payments; royalties