Research Activity – Page 6

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

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

1 month ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

1 month ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

Agentic AI is Here: Real-World Applications in Life Sciences & Healthcare (2025 Update)

1 month ago talkbio0Tagged agentic AI, Automation, Biological Science Disciplines, commercialization, Data Analysis, Health care facility, Pharma, Pharmacovigilance, Precision Medicine, R&D

Agentic AI; life sciences; healthcare; R&D; pharma; personalized medicine; pharmacovigilance; commercialization; automation; data analysis

Strand Therapeutics Raises $153M Series B to Advance mRNA Tumor Drugs

1 month ago talkbio0Tagged Big Pharma investors, biotech financing, Clinical Trials, Genomic Orientation, interleukin-12, mRNA cancer, Series B funding, Solid Neoplasm, STX-001

Strand Therapeutics; Series B funding; mRNA cancer therapy; STX-001; IL-12; solid tumors; Big Pharma investors; clinical trial results; biotech financing

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

1 month ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

XtalPi and DoveTree Announce Landmark $6 Billion AI-Powered Drug Discovery Collaboration

1 month ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, Collaboration, Dosage Forms, DoveTree Medicines, Drug Discovery, Gregory Verdine, Immunology, Metabolic Diseases, milestone payments, Neoplasms, Neurology speciality, Robotics, royalties, upfront payment, XtalPi

XtalPi; DoveTree Medicines; AI drug discovery; robotics; pharmaceutical R&D; Gregory Verdine; oncology; immunology; neurology; metabolic diseases; collaboration; upfront payment; milestone payments; royalties