Clinical Trials – Talk Bio

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

6 hours 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

6 hours 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

5 days 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

6 days 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

6 days 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

6 days 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

Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

1 week ago talkbio0Tagged Capricor Therapeutics, Cell Therapy, Clinical Trials, data misinterpretation, deramiocel, Effectiveness, Endpoints, HOPE-2 trial, Muscular Dystrophy, Duchenne, Non-Parametric Test, Rejection, Statistical Significance, United States Food and Drug Administration

Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

1 week ago talkbio0Tagged Appointments, biotech startup, CEO, Clinical Trials, Immunology, Inflammation, Intent Biologics, Pfizer vet, Phase 3, Regenerative Medicine, Suneet Varma

Suneet Varma; Pfizer vet; Intent Biologics; CEO appointment; regenerative medicine; Phase 3 clinical trials; biotech startup; inflammation and immunology

Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates

1 week ago talkbio0Tagged agonists, alixorexton, Alkermes, Cataplexy, Clinical Trials, Daytime Somnolence, Excessive (qualifier value), Maintenance, MWT, Narcolepsy, orexins, oveporexton, Phase 3, Takeda, Wakefulness Test

Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)

Eli Lilly Touts ‘Striking’ Progression-Free Survival Results for Jaypirca in New Front-Line CLL Study

1 week ago talkbio0Tagged BRUIN, BTK inhibitor, Chronic Lymphocytic Leukemia, Clinical Trials, CLL, CLL-313, eli lilly, expansion, First line treatment, Jaypirca, Labels (device), Progression-Free Survival

Jaypirca; Eli Lilly; CLL; chronic lymphocytic leukemia; BRUIN CLL-313; progression-free survival; BTK inhibitor; first-line treatment; clinical trial; label expansion