Qualitative Concept – Page 2

Survival Benefit of Amgen’s Bemarituzumab in Gastric Cancer Attenuates at Final Analysis

1 week ago talkbio0Tagged amgen, Attenuated by (contextual qualifier), bemarituzumab, Benefit, final analysis, FORTITUDE-101, FORTITUDE-102, Malignant neoplasm of stomach, nivolumab, Opdivo, Overall Survival, Zai Lab

Amgen; bemarituzumab; gastric cancer; Phase 3 trial; overall survival; attenuated benefit; final analysis; FORTITUDE-101; FORTITUDE-102; Zai Lab; Opdivo; nivolumab

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

1 week ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

FDA Announces New Rare Disease Approval Programme

1 week ago talkbio0Tagged Accelerated, Approved, Biological Factors, conditional approval pathway, drug review, Endpoints, Infrequent, real-world data, streamlined process, Surrogate, United States Food and Drug Administration

FDA; rare disease; conditional approval pathway; accelerated approval; biologics; drug review; surrogate endpoints; real-world data; streamlined process

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

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

Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

1 week ago talkbio0Tagged Child, COVID19 (disease), Evidence, Prasad, regulatory decisions, risk-benefit analysis, Spikevax, United States Food and Drug Administration, vaccine approval, Vaccine Safety, Vaccines, Vinay

Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis

Ionis Posts Strong Results for Tryngolza in Severe Blood Fat Disease

1 week ago talkbio0Tagged Approved, cardiovascular risk reduction, drug launch, Familial chylomicronemia syndrome, Hypertriglyceridemia, Ionis Pharmaceuticals, Olezarsen, Phase III Essence study, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis Pharmaceuticals; Tryngolza; olezarsen; hypertriglyceridemia; triglycerides; Phase III Essence study; FDA approval; familial chylomicronemia syndrome; cardiovascular risk reduction; drug launch

Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile

1 week ago talkbio0Tagged benefit-risk profile, Clinical Trials, Dose-Limiting, Drug Development, Malignant Neoplasms, mesothelin, T-Cell engager, Toxicity aspects, ZW171, Zymeworks

Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity