ORG – Page 14 – Talk Bio

Novo Nordisk CEO Departs Amid Weight-Loss Drug Market Pressures; Flagship Biotech Appoints CEO from Scholar Rock

1 month ago talkbio0Tagged Appointments, biotech, CEO, Challenge, departure - ActRelationshipType, Eli Lilly competition, Flagship, Lars Fruergaard Jørgensen, Market, Nordisk, Obesity, Scholar Rock

Novo Nordisk; CEO departure; Lars Fruergaard Jørgensen; obesity drugs; weight-loss market; Eli Lilly competition; market challenges; Flagship Biotech; CEO appointment; Scholar Rock

Eli Lilly Expands RNA Pipeline with $1.3 Billion Rznomics Hearing Loss Pact

1 month ago talkbio0Tagged Deafness, Eli, Eli Lilly, gene therapy, pharmaceutical partnerships, RNA Editing, RNA therapeutics, Rznomics, Sensorineural Hearing Loss (disorder), trans-splicing ribozyme

Eli Lilly; Rznomics; RNA editing; hearing loss; gene therapy; pharmaceutical partnerships; biotech; trans-splicing ribozyme; sensorineural hearing loss; RNA therapeutics

Neurogene Details New Safety Measures After Young Patient’s Death in Rett Syndrome AAV Gene Therapy Trial

1 month ago talkbio0Tagged AAVS1 gene, ASGCT, Clinical Trials, Dosage, gene therapy, Individual Adjustment, Lymphohistiocytosis, Hemophagocytic, Measures, MECP2 gene, Neurogene, NGN-401, Rett Syndrome, Safety, United States Food and Drug Administration

Neurogene; AAV gene therapy; Rett syndrome; NGN-401; ASGCT; safety measures; HLH; clinical trial; MECP2 gene; FDA; dose adjustment

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

1 month ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

Three-Month Drought in U.S. Biotech IPOs: Recent Developments and Context

1 month ago talkbio0Tagged Droughts, IPO, Market, stocks

biotech IPO; biotech market; IPO drought; 2025; biotech fundraising; biotech stocks

Mayne Pharma Faces FDA Action Over ‘Misleading’ Drug Safety Claims Ahead of $430M Buyout

1 month ago talkbio0Tagged Claims, Contraceptives, Oral, Cosette Pharmaceuticals, drug safety, Mayne, Nextstellis, Pharma, United States Food and Drug Administration

Mayne Pharma; FDA; misleading claims; Nextstellis; birth control pill; drug safety; buyout; Cosette Pharmaceuticals

FDA Delays Decision on Biohaven’s Troriluzole for Rare Disease, Plans Advisory Committee Review

1 month ago talkbio0Tagged Advisory Committees, Ataxia, Spinocerebellar, Biohaven, Deferred, disease drug, Extension, Infrequent, Neurodegenerative Disorders, PDUFA, Troriluzole, United States Food and Drug Administration

Biohaven; FDA delay; troriluzole; spinocerebellar ataxia (SCA); rare disease drug; PDUFA extension; advisory committee; neurodegenerative disease

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

1 month 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