Clinical Trials – Page 4

Lilly’s Mounjaro Shows Strong Results in Youth Type 2 Diabetes, Paving Way for Expansion

1 month ago talkbio0Tagged Adolescent (age group), Body mass index procedure, Child, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, eli lilly, Hemoglobin A1c measurement, Mounjaro, SURPASS-PEDS

Mounjaro; tirzepatide; type 2 diabetes; children; adolescents; SURPASS-PEDS; A1C reduction; BMI reduction; clinical trial; Eli Lilly

ArsenalBio Lays Off 50% of Staff in Major Strategic Pivot

1 month ago talkbio0Tagged AB-2100, ArsenalBio, Cell Therapy, Clinical Trials, layoffs, Myers, restructuring, Squibb partnership, Staff

ArsenalBio; layoffs; biotech; staff reduction; restructuring; cell therapy; AB-2100; clinical trials; Bristol Myers Squibb partnership

AstraZeneca’s Saphnelo Succeeds in Phase III as Self-Injectable Lupus Treatment

1 month ago talkbio0Tagged anifrolumab, AstraZeneca, Clinical Trials, disease activity, Encephalitis, St. Louis, Lupus Erythematosus, Systemic, Phase III, Saphnelo, Self-Injectable, subcutaneous, TULIP-SC trial

AstraZeneca; Saphnelo; anifrolumab; Phase III; TULIP-SC trial; systemic lupus erythematosus; SLE; self-injectable; subcutaneous; clinical trial; disease activity reduction

Priovant Announces Successful Phase III Results for Brepocitinib in Dermatomyositis (VALOR Study)

1 month ago talkbio0Tagged Brepocitinib, Clinical Trials, cutaneous remission, Dermatomyositis, NDA filing, Phase III, Priovant, Roivant, Steroids, Total Improvement Score, Tumor stage Tis, VALOR study

Priovant; Roivant; brepocitinib; Phase III; VALOR study; dermatomyositis; clinical trial; Total Improvement Score; TIS; steroid reduction; cutaneous remission; NDA filing

Ollin Biosciences Launches with $100M to Challenge Roche in Eye Disease Market

1 month ago talkbio0Tagged Ang2, Biosciences, Clinical Trials, Disorder of eye, Macular edema due to diabetes mellitus, Ollin, OLN324, Roche (company), Vabysmo, Vascular Endothelial Growth Factor A, Wet AMD

Ollin Biosciences; Roche; eye disease; biotech; VEGF-A; Ang2; wet AMD; diabetic macular edema; clinical trial; OLN324; Vabysmo

Next-Generation Psoriasis Drugs Aim to Reshape Treatment Landscape

1 month ago talkbio0Tagged Approved, Clinical Trials, icotrokinra, inhibitors, interleukin-23, next-generation biologics, oral peptides, Piclidenoson, TYK2 gene, United States Food and Drug Administration, Vunakizumab

psoriasis; next-generation biologics; icotrokinra; IL-23 inhibitors; oral peptides; TYK2 inhibitors; vunakizumab; piclidenoson; clinical trials; FDA approval

FibroGen Settles with SEC for $1.25M Over Roxadustat Data Tampering Allegations

1 month ago talkbio0Tagged Anemia, cardiovascular safety, Clinical Trials, data manipulation, FibroGen, Kin-Hung Peony Yu, Phase 3, roxadustat, seconds, settlement, United States Food and Drug Administration

FibroGen; SEC; roxadustat; data manipulation; settlement; Kin-Hung Peony Yu; phase 3 clinical trial; anemia drug; cardiovascular safety; FDA

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

1 month ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks

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

1 month 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

PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom

1 month ago talkbio0Tagged cash runway, Clinical Trials, Familial mitral valve prolapse, File (record), Frequency of Responses, Funding, ovarian neoplasm, TP53 gene, United States Food and Drug Administration

PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway