Clinical Research

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

3 days 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

Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly

1 week ago talkbio0Tagged Antibodies, Bispecific, Approved, Clinical Research, Conditional, EU, GO29781, Lunsumio, Lymphoma, Follicular, marketing authorisation, Relapsed/Refractory, Roche (company), subcutaneous, Tepkinly

Roche; Lunsumio; subcutaneous; EU approval; conditional marketing authorisation; follicular lymphoma; bispecific antibody; Tepkinly; CD20xCD3; relapsed/refractory; GO29781 study

FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs

3 weeks ago talkbio0Tagged Biopharmaceuticals, biosimilar guidance, biosimilarity, Clinical Research, Comparative Efficacy, draft guidance, Drug Costs, four-letter suffix, naming convention, United States Food and Drug Administration

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines

Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

2 months ago talkbio0Tagged activin signaling, AKAP9 protein, human, Approved, Clinical Research, clinical worsening, early disease, Merck, PAH, Phase 3 trial, Sotatercept, United States Food and Drug Administration, Winrevair

Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial

Placebo Response Trips Up Harmony Biosciences’ Fragile X Drug in Late-Stage Phase 3 Trial

2 months ago talkbio0Tagged Clinical Research, Clinical trial failure, Fragile X Syndrome, Harmony Biosciences, Placebos, RECONNECT, Response process, transdermal cannabidiol gel

Harmony Biosciences; ZYN002; Fragile X syndrome; Phase 3 trial; placebo response; clinical trial failure; RECONNECT study; transdermal cannabidiol gel

Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial

2 months ago talkbio0Tagged Biopharma, cash runway, Clinical Research, Feedback - system communication, layoffs, Microbiome, Microbiome SER-155, Seres, United States Food and Drug Administration

Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway

Neurocrine Biosciences Reports Positive Phase 2 Results for Osavampator in Major Depressive Disorder

2 months ago talkbio0Tagged adjunctive treatment, AMPA-PAM, Biosciences, Clinical Research, Clinical Trials, Mental Depression, Neurocrine, osavampator, safety profile, SAVITRI

Neurocrine Biosciences; osavampator; Phase 2 results; major depressive disorder; AMPA-PAM; SAVITRI study; clinical trial; adjunctive treatment; depression; safety profile

Roche’s Oral SERD Achieves Progression-Free Survival Milestone in Pivotal Breast Cancer Trial

2 months ago talkbio0Tagged advanced breast cancer, Clinical Research, ER-positive, giredestrant, Hormone Therapy, Malignant neoplasm of breast, Oral SERD, Phase 3 Clinical Trials, Progression-Free Survival, Roche (company)

Roche; oral SERD; giredestrant; progression-free survival; pivotal study; breast cancer; ER-positive; endocrine therapy; Phase III trial; advanced breast cancer

J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results

3 months ago talkbio0Tagged Autoimmune Diseases, Clinical Research, Clinical trial failure, daisy, Imaavy, Johnson and Johnson, Nipocalimab, Phase 2a Trial, Rheumatoid Arthritis

Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases

FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies

3 months ago talkbio0Tagged Clinical Research, Complete Response Letter, drug efficacy, factor IX, Friedreich 's ataxia, Rejection, United States Food and Drug Administration, vatiquinone

FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies