Language – Talk Bio

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

1 month 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

1 month 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

2 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

3 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

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

3 months ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

3 months ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial