Pharmacologic Substance

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

Drugmakers Push US Expansion After Trump’s 100% Pharma Tariff Threat

3 days ago talkbio0Tagged branded drugs, drugmakers, genentech, Manufacturing, Roche (company), Section 232, supply chain, Trump tariff, U.S.

Trump tariff; pharmaceuticals; US manufacturing; branded drugs; drugmakers; Genentech; Roche; Novo Nordisk; Section 232; supply chain

Eye Disease Biotech Kala Bio Collapses After Failed Clinical Trial, Lender Takes Control

3 days ago talkbio0Tagged Clinical trial failure, Corneal epithelial defect, Experimental drug, foreclosure proceedings, Kala Bio, KPI-012, lender takeover, Oxford Finance, PCED, Persistent, Shock, Workforce reduction

Kala Bio; biotech collapse; failed drug trial; KPI-012; persistent corneal epithelial defect; PCED; lender takeover; Oxford Finance; foreclosure proceedings; workforce reduction; clinical trial failure

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

Terns Ditches Obesity Pill After Phase 2 Letdown, Shifts Focus to Cancer Pipeline

3 days ago talkbio0Tagged liver enzyme elevation, Metabolic Diseases, Myeloid Leukemia, Chronic, Neoplasms, Obesity Drug, Phase 2 trial, Product containing glucagon-like peptide 1 receptor agonist (product), TERN-601, TERN-701, Terns, Weight Loss

Terns Pharmaceuticals; TERN-601; obesity drug; GLP-1 receptor agonist; Phase 2 trial; weight loss; liver enzyme elevation; oncology; TERN-701; chronic myeloid leukemia (CML); metabolic disease

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

3 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

3 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