September 2024
Sanofi’s Tolebrutinib Shows Mixed Results in Phase 3 MS Trials, Plans for FDA Filing Remain
Tolebrutinib, Sanofi, Multiple Sclerosis, Phase 3 Trials, FDA Filing
Novavax’s Updated COVID-19 Vaccine Receives FDA Emergency Use Authorization
Novavax, COVID-19 vaccine, FDA, Emergency Use Authorization, protein-based vaccine, JN.1 variant
Women Breaking Barriers in Drug Development: Celebrating Leadership and Innovation
Women in drug development, gender equity, STEM, pharmaceutical industry, leadership, innovation
Arrowhead Pharmaceuticals Highlights Key Pancreatitis Data from Phase 3 Lipid Disease Study to Distinguish Itself from Ionis
Arrowhead Pharmaceuticals, Ionis Pharmaceuticals, Plozasiran, Olezarsen, Severe Hypertriglyceridemia (SHTG), Familial Chylomicronemia Syndrome (FCS), Acute Pancreatitis, RNAi Therapy, Triglyceride Reduction
Sanofi’s Tolebrutinib Shows Mixed Results in Multiple Sclerosis Trials
Sanofi, Tolebrutinib, Multiple Sclerosis, BTK Inhibitor, Clinical Trials
Bayer’s Asundexian Fails to Prevent Strokes, Jeopardizing $5.5 Billion Blockbuster Hopes
Bayer, asundexian, stroke prevention, atrial fibrillation, Factor XI inhibitors, clinical trials
Vutrisiran Shows Promising Results in Phase 3 Study for ATTR-CM Treatment
Vutrisiran, ATTR-CM, Phase 3 Study, Alnylam Pharmaceuticals, HELIOS-B
NuCana Terminates Mid-Stage Colorectal Cancer Trial Due to Disappointing Results
NuCana, colorectal cancer, chemotherapy derivative, mid-stage trial, disappointing results
FDA Establishes AI Council to Oversee Ongoing and Future AI Projects
FDA, AI Council, Digital Health Advisory Committee, Artificial Intelligence, Machine Learning, Regulatory Guidance
HUTCHMED Withdraws Fruquintinib Application for Second-Line Gastric Cancer Treatment in China
HUTCHMED, fruquintinib, gastric cancer, second-line treatment, China, NDA withdrawal