Amino Acid, Peptide, or Protein

FDA Approves GSK’s Blenrep for Multiple Myeloma Treatment, Marking a Market Return

2 days ago talkbio0Tagged Approved, Blenrep, bortezomib, dexamethasone, Multiple Myeloma, SmithKline Beecham, United States Food and Drug Administration

Blenrep; GSK; FDA Approval; Multiple Myeloma; Bortezomib; Dexamethasone

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 days ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

2 days ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity

Moderna Halts Development of CMV Vaccine After Phase 3 Failure

3 days ago talkbio0Tagged Clinical trial failure, Congenital Cytomegalovirus Infection, Cytomegalovirus Infections, Effectiveness, Moderna, mRNA-1647 cytomegalovirus vaccine, Phase 3 trial, Vaccines

Moderna; CMV vaccine; mRNA-1647; Phase 3 trial; Congenital cytomegalovirus; Vaccine efficacy; Clinical trial failure

Acrivon Therapeutics Showcases AP3 Platform and Preclinical Data for ACR-2316 with Three Poster Presentations at AACR-NCI-EORTC 2025

3 days ago talkbio0Tagged ACR-2316, Acrivon, AP3, Conferences, Generative Phosphoproteomics, Inhibitor, KaiSR, partial response, PKMYT1 protein, human, Platform, PLK1 gene, precision oncology, preclinical data, Study models, WEE1 inhibitor

Acrivon Therapeutics; AP3 platform; Generative Phosphoproteomics; KaiSR model; ACR-2316; AACR-NCI-EORTC conference; preclinical data; partial response; WEE1 inhibitor; PKMYT1 inhibitor; PLK1; precision oncology

Roche in Talks With US on Drug Pricing; Sets Out Pipeline and Dealmaking Ambitions

3 days ago talkbio0Tagged Benefit, dealmaking, direct-to-consumer sales, drug price, gene therapy, Government, Hemlibra, Investments, manager, Manufacturing, Ocrevus, Pharmaceutical Services, pipeline, R&D, Roche (company), U.S., Vabysmo

Roche; drug pricing; US government; pharmacy benefit managers; direct-to-consumer sales; pipeline; dealmaking; US investment; manufacturing; gene therapy; R&D; Ocrevus; Hemlibra; Vabysmo

ESMO Spotlight: Flagship ADCs move into early-stage cancer to validate chemo-displacement ambitions

4 days ago talkbio0Tagged 2025, ADCs, Administration occupational activities, Antibody-Drug Conjugates, Biological Markers, chemo-displacement, Datopotamab deruxtecan, Datroway, Enhertu, ESMO, HER2-positive, Limited stage (cancer stage), Malignant neoplasm of breast, Toxicity aspects, trastuzumab, Triple Negative Breast Neoplasms

ESMO 2025; antibody-drug conjugates; ADCs; early-stage cancer; chemo-displacement; trastuzumab deruxtecan; ENHERTU; datopotamab deruxtecan; DATROWAY; breast cancer; HER2-positive; triple-negative breast cancer; biomarkers; toxicity management

Sanofi’s efdoralprin alfa (INBRX-101) achieves all endpoints in Phase 2 alpha-1 antitrypsin deficiency (AATD) trial

4 days ago talkbio0Tagged Acquisition, alpha 1-Antitrypsin Deficiency, efdoralprin alfa, INBRX-101, Inhibrx, Phase 2, plasma-derived therapy, Rare Diseases, sanofi, Zemaira

Sanofi; efdoralprin alfa; INBRX-101; AATD; alpha-1 antitrypsin deficiency; Phase 2; Inhibrx; acquisition; rare disease; plasma-derived therapy; Zemaira

Alector’s GSK-partnered dementia drug latozinemab fails in late-stage trial

4 days ago talkbio0Tagged Alector, Clinical trial failure, Drug Development, Latozinemab, Phase 3 trial, Pick Disease of the Brain, Presenile dementia, Progranulins, SmithKline Beecham

Alector; GSK; latozinemab; dementia; frontotemporal dementia; Phase 3 trial; clinical trial failure; progranulin; drug development

Takeda and Innovent Forge $1.2B Upfront Oncology Pact for Bispecific and ADC Therapies, Total Deal Valued Up to $11.4B

4 days ago talkbio0Tagged Antibodies, Bispecific, Antibody-Drug Conjugates, Cancer Therapeutic Procedure, co-development, global strategic partnership, IBI343, IBI363, Innovent Biologics, Neoplasms, Payments, Takeda

Takeda; Innovent Biologics; global strategic partnership; bispecific antibody; antibody-drug conjugate (ADC); oncology; IBI363; IBI343; IBI3001; $1.2 billion upfront; $11.4 billion total deal; cancer therapy; co-development; milestone payments