Gene or Genome – Talk Bio

FDA Lifts Partial Hold on Merck and Daiichi Sankyo’s B7-H3 ADC Trial for Lung Cancer[6]

3 days ago talkbio0Tagged CD276 gene, Daiichi, Deruxtecan, I-DXd, IDeate-Lung02, ifinatamab, Lifting, Merck, Sankyo, Small cell carcinoma of lung, therapeutic autologous dendritic cells, United States Food and Drug Administration

FDA; partial hold lifted; Merck; Daiichi Sankyo; ifinatamab deruxtecan; I-DXd; B7-H3 ADC; small cell lung cancer; IDeate-Lung02

Eisai Licenses Nuvation Bio’s Taletrectinib for ROS1+ Lung Cancer in Europe and Asia

3 days ago talkbio0Tagged Eisai, licensing agreement, Malignant neoplasm of lung, Non-Small Cell Lung Carcinoma, Nuvation Bio, ROS1 gene, taletrectinib

Eisai; Nuvation Bio; taletrectinib; ROS1+ NSCLC; licensing agreement; lung cancer

Aktis Oncology’s 25% IPO jump lifts optimism for a biotech IPO rebound in 2026

7 days ago talkbio0Tagged Aktis, AKTS, Biotech IPOs, bounce, Capital Markets, CD276 gene, Eli Lilly backing, IPO, NECTIN4 gene, Neoplasms, Radiopharmaceuticals, Window (physical object)

Aktis Oncology IPO; AKTS; 2026 biotech IPOs; IPO bounce; radiopharmaceuticals; Eli Lilly backing; biotech capital markets; Nectin-4; B7-H3; IPO window 2026

Roche returns to Chinese biotech MediLink for another ADC pact

7 days ago talkbio0Tagged Antibody-Drug Conjugates, CD276 gene, China, Neoplasms, Platform, Roche (company), Small cell carcinoma of lung, small-cell lung cancer, Solid Neoplasm, therapeutic autologous dendritic cells, TMALIN, YL201

Roche; MediLink Therapeutics; YL201; antibody-drug conjugate; ADC; B7-H3; TMALIN platform; small-cell lung cancer; SCLC; solid tumors; licensing deal; oncology; China biotech

Enliven’s Phase 1b ELVN‑001 leukemia pill shows competitive efficacy vs. Novartis and Terns CML TKIs

7 days ago talkbio0Tagged asciminib, BCR-ABL1, Contraceptives, Oral, Deep molecular response, ELVN-001, ENABLE trial, Enliven Therapeutics, Inhibitor, Measles-Mumps-Rubella Vaccine, Molecular Response, Myeloid Leukemia, Chronic, Novartis, Phase 1b, Protein-tyrosine kinase inhibitor, T315I, TERN-701, Terns, TKI, WDR20 gene

Enliven Therapeutics; ELVN-001; Phase 1b; chronic myeloid leukemia; CML; BCR-ABL1 inhibitor; major molecular response; MMR; deep molecular response; DMR; asciminib; Novartis; Terns Pharmaceuticals; TERN-701; T315I; ENABLE trial; CML pill; tyrosine kinase inhibitor; TKI; best-in-class

Obesity biotech Alveus raises ~$160M Series A to advance MariTide‑like GLP‑1/GIPR drug and amylin pipeline

7 days ago talkbio0Tagged * * New Rhein Healthcare Investors, * * Sanofi Capital, ALV-100, ALV-200, Alveus Therapeutics, Amylin, Andera Partners, Antagonist muscle action, GIPR gene, MariTide-like, Metabolic Diseases, Obesity, Omega Funds, Product containing glucagon-like peptide 1 receptor agonist (product), Series

Alveus Therapeutics; obesity biotech; $160 million Series A; ALV-100; MariTide-like; GLP-1 receptor agonist; GIPR antagonist; amylin; ALV-200; obesity drugs; metabolic diseases; Sanofi Capital; New Rhein Healthcare Investors; Andera Partners; Omega Funds

2025 FDA staff cuts and their impact on new drug review timelines

1 week ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

1 week ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

1 week ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions

2025 FDA staff cuts and their impact on new drug review timelines

1 week ago talkbio0Tagged 2025, CHARGE Syndrome, Drug Approval, drug review, HHS, layoffs, PDUFA, Programs - Publication Format, regulatory timelines, RFK gene, Staff, TimeLine Fluoride Releasing Resin, United States Food and Drug Administration, user fee, Workforce

FDA layoffs 2025; drug review timelines; user fee programs; HHS staff cuts; RFK Jr. layoffs; PDUFA; regulatory timelines; drug approvals; FDA workforce reductions