Language – Talk Bio

MoonLake revives FDA push; biotech trio to debut in Hong Kong

2 weeks ago talkbio0Tagged * * Investor Day, Asia, Biological Factors, Blackfoot language, Capital, Hidradenitis Suppurativa, Hong Kong, HS drug approval pathway, immunotherapeutics, License Application, Market, MIRA trial, MoonLake, sonelokimab, Type B meeting, United States Food and Drug Administration, VELA-1 trial, VELA-2 trial

MoonLake Immunotherapeutics; Sonelokimab; Hidradenitis Suppurativa; FDA Type B meeting; Biologics License Application; BLA H2 2026; VELA-1 trial; VELA-2 trial; MIRA trial; HS drug approval pathway; investor day February 23 2026; Hong Kong biotech IPOs; Hong Kong listing; Asia biotech capital markets

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

1 month 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

Apple Tree files for bankruptcy as it seeks fresh funding from Russian billionaire backer

2 months ago talkbio0Tagged backer, Bankruptcy filing, debt obligations, financing characteristics, insolvency, investor rescue, Malus domestica, restructuring, Russian language

Apple Tree; bankruptcy filing; insolvency; Russian billionaire backer; restructuring; financing deal; debt obligations; investor rescue

Wave Life Sciences RNA obesity shot shows fat loss with muscle preservation but trails Eli Lilly’s candidates

2 months ago talkbio0Tagged Adangme language, eli lilly, fat loss, INHBE, Injection of therapeutic agent, muscle preservation, Obesity, RNA obesity, Scientific Sessions, Wave Life Sciences, WVE-007

Wave Life Sciences; WVE-007; INHBE; RNA obesity drug; obesity shot; fat loss; muscle preservation; Eli Lilly; ADA Scientific Sessions

Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management

2 months ago talkbio0Tagged Chinese Language, Clinical Research, Gan & Lee Pharmaceuticals, Glucagon-Like Peptide 1, GRADUAL-3, innovation, once-monthly, Phase 3, Rheumatoid Arthritis, Weight maintenance regimen

Gan & Lee Pharmaceuticals; Phase 3 clinical study; GRADUAL-3; once-monthly GLP-1 RA; weight management; Chinese innovation

Chinese Biotechs Shed Fast-Follower Reputations as Innovation Surges in 2025

2 months ago talkbio0Tagged Biopharma, China, Chinese Language, Clinical Trials, drug candidates, global drug pipeline, innovation, leader, R&D, regulatory reforms

Chinese biotech innovation; fast-follower to leader; biopharma R&D; global drug pipeline; regulatory reforms; clinical trials; Made in China 2025; novel drug candidates

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

3 months ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

Santen Announces Completion of Share Buyback

3 months ago talkbio0Tagged buyback, Dosage Forms, equity buyback, Japanese language, Occupational activity of managing finances, repurchase, Santen, shareholder value

Santen Pharmaceutical; share buyback; repurchase; equity buyback; shareholder value; Japanese pharmaceuticals; financial management

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

3 months ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

4 months ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing