Immunologic Factor – Page 4

FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone

4 weeks ago talkbio0Tagged agency staffing shortages, Amyotrophic Lateral Sclerosis, delays, narsoplimab, NUZ-001, Omeros Corporation, regulatory review, Study on Hold, Transplantation, United States Food and Drug Administration

FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

4 weeks ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

NIH and HHS Cancel Major mRNA Vaccine Research Funding, Citing Lack of Public Trust

4 weeks ago talkbio0Tagged BARDA, COVID19 (disease), grant cancellation, Jay Bhattacharya, mRNA Vaccine, NIH Mouse, public trust, research funding, RFK Jr., Vaccination Hesitancy

NIH; mRNA vaccine; public trust; research funding; BARDA; COVID-19; vaccine hesitancy; RFK Jr.; Jay Bhattacharya; grant cancellation

Phase III Study: Perioperative Padcev & Keytruda Combo Significantly Improves Survival in Bladder Cancer

4 weeks ago talkbio0Tagged cisplatin-ineligible, enfortumab, Event-Free Survival, Keytruda, Malignant neoplasm of urinary bladder, muscle-invasive bladder cancer, Overall Survival, Padcev, pembrolizumab, perioperative, Phase III, vedotin

Padcev; Keytruda; enfortumab vedotin; pembrolizumab; phase III; bladder cancer; muscle-invasive bladder cancer; cisplatin-ineligible; perioperative; event-free survival; overall survival

Novartis antibody ianalumab clinches another Phase 3 win in rare blood disease (ITP)

1 month ago talkbio0Tagged Autoimmune, Autoimmune thrombocytopenia, B-cell depletion, ianalumab, Infrequent, Inosine Triphosphate, Novartis, Phase 3, platelet levels, Psychological inhibition, regulatory submissions, Sjögren 's disease, TNFRSF13C protein, human, treatment failure, VAY736

Novartis; ianalumab; VAY736; primary immune thrombocytopenia; ITP; rare disease; Phase 3; time to treatment failure; safe platelet levels; eltrombopag; autoimmune; B-cell depletion; BAFF-R inhibition; Sjögren’s disease; regulatory submissions

FDA may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations

1 month ago talkbio0Tagged Advice, authorization, Centers for Disease Control and Prevention (U.S.), Child, Comparison, COVID19 (disease), EUA, Eua (gastropod), Moderna, Pediatric brand name, Pfizer-BioNTech, Regulatory Framework, renewal, United States Food and Drug Administration, Vaccination, Vaccines

FDA; Pfizer-BioNTech; pediatric COVID-19 vaccine; EUA renewal; authorization not renewed; child vaccinations; fall 2025; regulatory framework; Moderna comparison; CDC guidance

Vaxart Seeks Clarity After BARDA Suspends Funding for Oral COVID-19 Vaccine Project Again

1 month ago talkbio0Tagged ATI, BARDA, CHARGE Syndrome, Clinical Trials, COVID19 (disease), Oral cavity, Project NextGen, stop work, Vaccines, Vaxart

Vaxart; BARDA; vaccine funding; stop work order; oral COVID-19 vaccine; Project NextGen; clinical trial; HHS; ATI

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

1 month ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Novartis plans global filings after ianalumab hits primary endpoints in two Phase 3 Sjögren’s disease trials

1 month ago talkbio0Tagged B-cell depletion, BAFF‑R, cellular targeting, ESSDAI, ianalumab, NEPTUNUS-1, NEPTUNUS-2, Novartis, Phase 3, regulatory filings, safety profile, Sjögren 's disease

Novartis; ianalumab; BAFF‑R; B-cell depletion; Sjögren’s disease; NEPTUNUS-1; NEPTUNUS-2; ESSDAI; Phase 3; regulatory filings; first targeted treatment; safety profile

HHS ousts MAHA implementation lead amid rushed cancellations of $500M in mRNA vaccine contracts

1 month ago talkbio0Tagged BARDA, CHARGE Syndrome, Contract agreement, Gray Delany, MAHA, Moderna, mRNA contracts, Pfizer, Policy, Robert F. Kennedy, Seqirus, Shakeup, SMPX gene, Staff, terminations, Vaccines

HHS; MAHA; Gray Delany; mRNA contracts; BARDA; Robert F. Kennedy Jr.; vaccine policy; contract terminations; Moderna; Pfizer; CSL Seqirus; staff shakeup