August 12, 2025 – Talk Bio

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

2 weeks 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

2 weeks 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

2 weeks 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

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

2 weeks 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

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

2 weeks 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

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

2 weeks 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

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

2 weeks 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