Biomedical Occupation or Discipline

FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

19 hours ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

2 days ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

Eli Lilly to Acquire Adverum Biotechnologies in Gene Therapy Deal; Captain T Cell Secures €20M Funding

2 days ago talkbio0Tagged Acquisition, Adverum Biotechnologies, biotech, Captain T Cell, contingent value rights, CVR, eli lilly, financing characteristics, gene therapy, Investments, Ixo-vec, Ophthalmology specialty

Eli Lilly; Adverum Biotechnologies; Acquisition; Gene therapy; Ixo-vec; Contingent Value Rights (CVR); Ophthalmology; Captain T Cell; Financing; Biotech investment

Genmab Discontinues ProfoundBio-Derived ADC GEN1107 After Acquisition, Paralleling J&J’s Ambrx Buyout Area Developments

2 days ago talkbio0Tagged AbbVie, Acquisition, Ambrx, Antibody-Drug Conjugates, Drug Development, GEN1107, Genmab, J&J, Johnson and Johnson, Neoplasms, ProfoundBio, PTK7, PTK7 protein, human

Genmab; ProfoundBio; antibody-drug conjugate (ADC); GEN1107; PTK7; Ambrx; Johnson & Johnson (J&J); oncology; drug development; biotech acquisition; AbbVie lawsuit

Odyssey Therapeutics Appoints Dennis Dean as EVP, Head of Non-Clinical Development

1 week ago talkbio0Tagged Autoimmune Diseases, Biological Factors, Dennis Dean, Drug Development, executive vice president, Head of Non-Clinical Development, Odyssey Therapeutics, preclinical research

Odyssey Therapeutics; Dennis Dean; Executive Vice President; Head of Non-Clinical Development; preclinical research; autoimmune diseases; drug development; biopharmaceutical

Voyager Therapeutics Partners with Transition Bio for Small Molecule Neurodegenerative Drug Discovery; CRISPR Therapeutics Ends Work on CAR-T Therapy

1 week ago talkbio0Tagged Amyotrophic Lateral Sclerosis, CAR-T therapy, Clustered Regularly Interspaced Short Palindromic Repeats, Drug Development, Neurodegenerative Disorders, Partnership, Pick Disease of the Brain, small molecule drug discovery, TARDBP gene, Transition Bio, Voyager Therapeutics

Voyager Therapeutics; Transition Bio; ALS; frontotemporal dementia; TDP-43; small molecule drug discovery; neurodegenerative diseases; CRISPR Therapeutics; CAR-T therapy; partnership; drug development

Spotlight On: What to Watch at AHA 2025 – Key Science and Trends

1 week ago talkbio0Tagged 2025, Autoimmune hemolytic anemia, Cardiology discipline, cardiometabolic, Cardiopulmonary Resuscitation, Clinical Trials, coronary trials, gene editing therapies, Guidelines, Hypertensive disease, Interventional procedure, lipid management, Medical Valves, polypill, Science

AHA 2025; late-breaking science; clinical trials; cardiology; gene-editing therapies; polypill; lipid management; valve and coronary trials; cardiometabolic intervention; hypertension; CPR guidelines

Eli Lilly Strikes Multiple Deals for Ultra-Rare Eye Disease Gene Therapy and RNAi Partnerships

1 week ago talkbio0Tagged AAV-AIPL4, eli lilly, gene therapy, Genetic Leap, Leber congenital amaurosis-4, MeiraGTx, Ophthalmology specialty, partnerships, RNA Interference, SanegeneBio

Eli Lilly; MeiraGTx; gene therapy; Leber congenital amaurosis-4; AAV-AIPL4; Genetic Leap; RNAi; SanegeneBio; ophthalmology; biotech partnerships

Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025, Highlighting Integration of Clinical Innovation, Multi-Omics, and AI for Solid Tumor Therapies

2 weeks ago talkbio0Tagged Artificial Intelligence, CAN-2409, Candel Therapeutics, enLIGHTEN Discovery Platform, Immunotherapy, Malignant neoplasm of prostate, Multiomics, Non-Small Cell Lung Carcinoma, Precision Medicine, SITC, Solid Neoplasm

Candel Therapeutics; SITC 2025; immunotherapy; CAN-2409; multi-omics; artificial intelligence; solid tumors; enLIGHTEN Discovery Platform; prostate cancer; non-small cell lung cancer; precision medicine

Dr. Andreas Wallnöfer Named to Optigo Biotherapeutics Board of Directors

2 weeks ago talkbio0Tagged Andreas Wallnöfer, Biotechnology, board of directors, Dosage Forms, Drug Development, Hyaluronic Acid anchoring platform, IND-enabling studies, Ophthalmology specialty, Optigo Biotherapeutics, R&D, Retinal Diseases

Andreas Wallnöfer; Optigo Biotherapeutics; Board of Directors; ophthalmology; biotechnology; retinal diseases; IND-enabling studies; Hyaluronic Acid anchoring platform; pharmaceutical R&D; drug development