Clinical Trials
Amgen’s Mixed Results: A Tale of Two Readouts in Eczema and Myasthenia Gravis Trials
Amgen, Clinical Trials, Eczema, Myasthenia Gravis, Rocatinlimab, Uplizna, Biotechnology, Pharmaceutical Industry
Headlands Research Expands with New Clinical Trial Site in El Paso, Texas
Headlands Research, clinical trial site, El Paso, Texas, diversity in clinical research, clinical trials, medical research
Wave Life Sciences Reports Positive Interim Data for Duchenne Muscular Dystrophy Treatment
Wave Life Sciences, Duchenne Muscular Dystrophy, DMD, Exon 53 Skipping, WVE-N531, FORWARD-53 Clinical Trial, Interim Data, Muscle Health, Dystrophin Expression
Metsera’s Long-Acting GLP-1 Drug Shows Promising 7.5% Weight Loss in 36 Days, Paving Way for Monthly Dosing
Metsera, GLP-1, obesity treatment, long-acting drug, weight loss, monthly dosing, MET-097, clinical trial results.
Biohaven Revives Troriluzole Hopes with Positive Update for Spinocerebellar Ataxia
Troriluzole, Spinocerebellar Ataxia (SCA), Biohaven Pharmaceuticals, Neurodegenerative Disorders, FDA New Drug Application (NDA), Clinical Trials, Rare Diseases
Navigating Complex Regulatory Landscapes: The Importance of External Support for Biotech Sponsors in IRB, IBC, DMCs, and EACs
Biotech sponsors, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee), DMCs (Data Monitoring Committees), EACs (Ethics Advisory Committees), Regulatory compliance, Clinical trials, Gene therapy research, Risk management
FDA Issues Draft Guidance on Integrating Clinical Trials into Routine Clinical Practice and Enhancing Diversity in Clinical Studies
FDA, clinical trials, diversity, routine clinical practice, decentralized clinical trials, underrepresented populations, FDORA
Pfizer’s Next Challenge: Phase 3 Trials for Breakthrough Cancer Therapies
Pfizer, Phase 3 trials, cancer therapies, oncology pipeline, clinical trials
Merck’s Keytruda-Lenvima Combination Shows Promise in Liver Cancer Treatment
Keytruda, Lenvima, liver cancer, hepatocellular carcinoma, combination therapy, Merck, Eisai, clinical trials.
Incyte’s PD-1 Drug Zynyz: A Strategic Pipeline Component Despite Recent Trial Success
Incyte, Zynyz, PD-1 inhibitor, anal cancer, pipeline strategy, clinical trials, FDA approval