December 2025 – Page 6

FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer

1 month ago talkbio0Tagged Approved, Carcinoma breast stage IV, Enhertu, first-line, HER2-positive, Perjeta, United States Food and Drug Administration

Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line

China’s fast, low-cost gene and cell therapy testing boom draws Western interest

1 month ago talkbio0Tagged Advanced Therapy Medicinal Products, ATMP regulation China, CDE, Cell Therapy, China, clinical trial review, Clinical Trials, gene therapy, N-methyl-N-2-(methylsulfinyl)ethylpropionic acid amide, reforms, Shortened, therapies testing, Western biotech

China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing

Pilatus Raises $14M for First-in-Human Study of Anti-CD36 mAb

1 month ago talkbio0Tagged Anti-CD36 mAb, First-in-Human Study, Funding, Pilatus

Pilatus; funding; anti-CD36 mAb; first-in-human study; biotech

Hikma announces CEO change and Board appointment

1 month ago talkbio0Tagged * * Riad Mishlawi * *, Board appointment, CEO, Changing, Darwazah, executive leadership, Hikma Pharmaceuticals, Khalid Nabilsi, London

Hikma Pharmaceuticals; CEO change; Riad Mishlawi; Said Darwazah; Khalid Nabilsi; Board appointment; executive leadership; pharmaceuticals; London; 15 December 2025

Ankyra Therapeutics Appoints Sailaja Battula, PhD as Chief Scientific Officer

1 month ago talkbio0Tagged Ankyra Therapeutics, Appointments, Biotechnology, CSO, immuno-oncology, Sailaja Battula

Ankyra Therapeutics; Sailaja Battula; CSO appointment; immuno-oncology; biotechnology

NeOnc Technologies Reports Updated Clinical Results for Intranasal NEO100

1 month ago talkbio0Tagged Central Nervous System Neoplasms, clinical results, Compassionate Use, Intranasal approach, NEO100, NeOnc Technologies, NTHI, Overall Survival, Phase 1/2a trial, radiographic remission, recurrent astrocytoma, World Health Organization

NeOnc Technologies; NTHI; NEO100; intranasal NEO100; updated clinical results; recurrent astrocytoma; WHO Grade III/IV; radiographic remission; overall survival; compassionate use; Phase 1/2a trial; CNS cancers

Immunome’s desmoid tumor drug varegacestat posts landmark Phase 3 results, setting up a potential challenge to Merck KGaA’s Ogsiveo

1 month ago talkbio0Tagged Fibromatosis, Aggressive, Frequency of Responses, gamma secretase inhibitor, Immunome, Infrequent, Merck KGaA, NDA, Neoplasms, Ogsiveo, Phase 3 RINGSIDE trial, Progression-Free Survival, varegacestat

Immunome; varegacestat; desmoid tumors; Phase 3 RINGSIDE trial; gamma secretase inhibitor; Merck KGaA; Ogsiveo; progression-free survival; objective response rate; rare tumors; oncology; NDA filing

Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3

1 month ago talkbio0Tagged avacincaptad, AVD-104, Clinical trial failure, Clinical Trials, Dry AMD, Genus Aviceda, Geographic Atrophy, IZERVAY, pegol, Phase 3 prospects, Sialic Acid Binding Immunoglobulin-like Lectins

Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 month ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

Scaling for a New Era: The Rise of Radiopharma

1 month ago talkbio0Tagged Clinical Trials, CROs, Diagnostics, Funding, Lutetium-177, M&A, Neoplasms, Pet Animal, precision oncology, radioligand therapy, Radiopharmaceuticals, radiotheranostics, Research Infrastructure, supply chain, targeted alpha therapy

radiopharmaceuticals; radioligand therapy; oncology; precision oncology; targeted alpha therapy; Lutetium-177; Actinium-225; clinical trials; radiotheranostics; M&A; biotech funding; supply chain; infrastructure; CROs; companion diagnostics