Cell – Talk Bio

Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China

4 days ago talkbio0Tagged Cells, CEO, China, competitiveness, gene therapy, innovation, Modernization, Regulation, roundtable, United States Food and Drug Administration

FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

2 weeks ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

Astellas Secures $1.34B Licensing Deal for CLDN18.2-Targeted ADC with Evopoint Biosciences

2 weeks ago talkbio0Tagged Antibody-Drug Conjugates, Astellas, Evopoint Biosciences, Licensing Deal, Neoplasms, therapeutic autologous dendritic cells

Astellas; Evopoint Biosciences; CLDN18.2; antibody-drug conjugate; ADC; licensing deal; oncology; XNW27011

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

2 weeks ago talkbio0Tagged Application procedure, Clinical Trials, Daiichi, Deruxtecan, HER3, Merck, Non-Small Cell Lung Carcinoma, Overall Survival, patritumab, Sankyo, therapeutic autologous dendritic cells, United States Food and Drug Administration, Withdraw (activity)

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal

Sanofi Acquires Vigil Neuroscience for $470 Million, Bolstering Alzheimer’s Drug Pipeline

3 weeks ago talkbio0Tagged Acquisition, Agonist, Alzheimer 's disease, Microglia, Neurodegenerative Disorders, Phase 2 Trials, sanofi, TREM2, VG-3927, Vigil Neuroscience

Sanofi; Vigil Neuroscience; acquisition; Alzheimer’s disease; TREM2 agonist; VG-3927; microglia; neurodegenerative disease; Phase 2 trials; biotech deals

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

4 weeks ago talkbio0Tagged AbbVie, Accelerated, ADC, Approved, Emrelis, Malignant neoplasm of lung, MET protein, human, Non-Small Cell Lung Carcinoma, Protein Overexpression, Solid Neoplasm, Telisotuzumab, therapeutic autologous dendritic cells, United States Food and Drug Administration, vedotin-tllv

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

Federal Appeals Court Revives CRISPR Patent Dispute Between Broad Institute and University of California

4 weeks ago talkbio0Tagged Broad Institute, Clustered Regularly Interspaced Short Palindromic Repeats, Eukaryotic Cells, Federal Circuit, Gene Modification, Intellectual Property, Legal patent, PTAB, University of California

CRISPR; patent dispute; Broad Institute; University of California; Federal Circuit; PTAB; gene editing; intellectual property; eukaryotic cells

Caribou cuts 32% of staff, further purges pipeline to focus on 2 oncology CAR-T prospects

2 months ago talkbio0Tagged 32%, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, CAR-T, Cell Therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, Neoplasms, Reindeer, Staff, United States Food and Drug Administration

Reindeer, CAR-T, Staff, Neoplasms, Cell Therapy, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, United States Food and Drug Administration, 32%