Uncategorized – Page 19

Insmed’s Brinsupri Receives First-Ever FDA Approval for Progressive Lung Disease

1 month ago talkbio0Tagged Approved, brensocatib, Brinsupri, Bronchiectasis, CTSC gene, Inhibitor, Insmed, Lung diseases, neutrophil-mediated disease, non-cystic fibrosis bronchiectasis, Progressive, United States Food and Drug Administration

Brinsupri; Insmed; FDA approval; non-cystic fibrosis bronchiectasis; bronchiectasis; DPP1 inhibitor; brensocatib; progressive lung disease; neutrophil-mediated disease; first-in-class

Bayer Expands Oncology Pipeline with $1.3B Kumquat Deal

1 month ago talkbio0Tagged Approved, Bayer, Cancer Therapeutic Procedure, commercialization, G12D inhibitor, K-ras Oncogene, Kumquat Biosciences, milestone payments, Oncology Pipeline, precision oncology, United States Food and Drug Administration

Bayer; Kumquat Biosciences; oncology pipeline; KRAS G12D inhibitor; FDA approval; cancer therapy; precision oncology; commercialization; milestone payments

PureTech Spins Out Celea Therapeutics to Advance IPF Drug Candidate

1 month ago talkbio0Tagged Celea Therapeutics, Idiopathic Pulmonary Fibrosis, Lung diseases, LYT 100, Phase 3 trial, pirfenidone, Pulmonary Fibrosis, PureTech, spin-out

PureTech; Celea Therapeutics; spin-out; lung disease; idiopathic pulmonary fibrosis; IPF; deupirfenidone; LYT-100; Sven Dethlefs; phase 3 trial

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

1 month 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

After CDC shooting, employees and public health leaders urge RFK Jr. to change his rhetoric

1 month ago talkbio0Tagged campus, CDC, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Leadership, Officer David Rose, public health leaders, RFK Jr. rhetoric, Security Measures, Shooting sensation quality, vaccine misinformation, workplace safety

CDC shooting; RFK Jr. rhetoric; vaccine misinformation; CDC employee reactions; public health leaders; security measures; Atlanta CDC campus; Officer David Rose; HHS leadership; workplace safety

Bayer-allied NextRNA Therapeutics winds down operations after missing a milestone in their collaboration

1 month ago talkbio0Tagged Bayer, Dana-Farber, Funding, Long Intergenic Non-Protein Coding RNA, Massachusetts biotech, missed milestone, Neoplasms, NextRNA, Plant seeds, Series, shutdowns

NextRNA Therapeutics; Bayer; lncRNA; long non-coding RNA; oncology; biotech wind-down; missed milestone; Massachusetts biotech; seed and Series A funding; Dana-Farber; Carl Novina; 2025 biotech shutdowns

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

Obesity Leaders Dig Manufacturing Moats To Defend Injectable GLP-1 Empires

1 month ago talkbio0Tagged Bariatric Surgery, biosimilars/generics, Capital Expenditures, China, competition, constraints, eli lilly, GLP-1 pipeline, Glucagon-Like Peptide 1, manufacturing capacity, Market, Medicare, Nordisk, Obesity, Policy, Risk, Wegovy, Zepbound

GLP-1; manufacturing capacity; Eli Lilly; Novo Nordisk; obesity drugs; Wegovy; Zepbound; capital expenditures; supply constraints; market competition; Medicare coverage; policy risk; biosimilars/generics; China GLP-1 pipeline; bariatric surgery