Bristol-Myers Squibb Announces Studies Evaluating liso-cel in Multiple Additional Patient Populations, Site of Care and Disease Areas Presented at American Society of Hematology (ASH) Annual Meeting

Posted in Biotech by Medtech[y] Staff

December 09, 2019 • 2 min read

Bristol-Myers Squibb Company (NYSE: BMY) today announced data from multiple studies evaluating lisocabtagene maraleucel (liso-cel), an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells...

Merck to Acquire ArQule, Advancing Leadership in Oncology

Posted in Biotech by Medtech[y] Staff

December 09, 2019 • 2 min read

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ArQule, Inc. (Nasdaq: ARQL) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion...

Intercept Announces Publication of Results from the Interim Analysis of the Phase 3 REGENERATE Study of OCA for the Treatment of Fibrosis Due to NASH in The Lancet

Posted in Biotech by Medtech[y] Staff

December 06, 2019 • 2 min read

​Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the positive results from the interim analysis of the Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with fibrosis due to nonalcoholic steatohepatitis (NASH)...

Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis

Posted in Biotech by Medtech[y] Staff

December 05, 2019 • 2 min read

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate...

Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder

Posted in Biotech by Medtech[y] Staff

December 05, 2019 • 4 min read

Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo...

GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on EPIDIOLEX (cannabidiol) Oral Solution at the American Epilepsy Society Annual Meeting

Posted in Biotech by Medtech[y] Staff

December 05, 2019 • 2 min read

​GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences announced today that a variety of data, including results from completed Phase 3 trials of EPIDIOLEX (cannabidiol) oral solution CV, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 6-10, in Baltimore...

Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND

Posted in Biotech by Medtech[y] Staff

December 05, 2019 • 2 min read

​Cytokinetics (Nasdaq: CYTK) today announced that new results were presented at the 30th International Symposium on ALS/MND in Perth, Australia, including additional analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS)...