Geographic Area – Talk Bio

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

8 hours 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

Hikma announces CEO change and Board appointment

11 hours 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

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

24 hours 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

Innovent’s Mazdutide Shows Promising Obesity Data in Adolescents; No Everest PCSK9 News

4 days ago talkbio0Tagged Adolescent (age group), China, Innovent, mazdutide, Obesity, Phase 1b, Weight Loss

Innovent; mazdutide; obesity; adolescents; Phase 1b; weight loss; China

The Endpoints 100: Biotech CEOs are feeling more upbeat about the road ahead

4 days ago talkbio0Tagged Attitude, biopharma executives, CEOs, dealmaking, E100 survey, Endpoints, Industry, IPO, Market, Recovery - action, reorganization, Sentiment, Trump administration, United States Food and Drug Administration, Window (physical object)

Endpoints 100; E100 survey; biotech CEOs; biopharma executives; industry sentiment; market recovery; dealmaking; IPO window; Trump administration; FDA reorganization; tariffs; 2025 outlook

Insilico Medicine and TaiGen sign exclusive licensing deal for AI-designed PHD inhibitor ISM4808 to treat anemia in chronic kidney disease

4 days ago talkbio0Tagged AI-driven, Anemia, CDE, China, Chronic Kidney Diseases, Clearance, clinical-stage biotech, Drug Discovery, Generative AI, Indonesian language, Insilico Medicine, ISM4808, License Agreement, Oral cavity, Ph.D., Pharma, PHD inhibitor, TaiGen Biotechnology

Insilico Medicine; TaiGen Biotechnology; license agreement; ISM4808; PHD inhibitor; anemia of Chronic Kidney Disease; CKD anemia; AI-driven drug discovery; Pharma.AI; Greater China rights; oral PHD inhibitor; IND clearance; China CDE; generative AI; clinical-stage biotech

Zealand Pharma and OTR Therapeutics in multi-program strategic collaboration for metabolic diseases

5 days ago talkbio0Tagged China, License Agreement, Metabolic Diseases, milestone payments, Obesity, oral small-molecule therapeutics, OXTR gene, Partnership, royalties, strategic collaboration, upfront payment, Zealand Pharma

Zealand Pharma; OTR Therapeutics; strategic collaboration; license agreement; metabolic diseases; obesity; oral small-molecule therapeutics; R&D partnership; China biotech; upfront payment; milestone payments; royalties

UK cuts 2026 new-medicine rebate rate to 14.5% under VPAG

6 days ago talkbio0Tagged branded medicines, clawback rate, Drug Industry, drug price, Growth, Nance-Horan syndrome, rebate rate, United Kingdom, valproic acid glucuronide, Voluntary Scheme

United Kingdom; VPAG; Voluntary Scheme for Branded Medicines Pricing Access and Growth; rebate rate; clawback rate; new medicines; NHS; drug pricing; pharmaceutical industry; 2026

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

6 days ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

Mindpeak Secures First Patent for Advanced AI Method in Digital Pathology

7 days ago talkbio0Tagged AI model, AI-powered, cell classification, Diagnostics, digital pathology, EU, Histopathological aspects, Legal patent, Mindpeak, oncology diagnostics, Pathology, Precision - temporal, Training Programs, United Kingdom, Validation

Mindpeak; digital pathology; AI-powered pathology; oncology diagnostics; cell classification; histopathology; EU patent; United Kingdom validation; AI model training; precision diagnostics