Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’s Durham, N.C. site, a multi-product gene therapy manufacturing facility.
Moderna, Inc. (NASDAQ:MRNA), has launched the Moderna Charitable Foundation to promote public health, access to quality healthcare and educational opportunities, particularly in underserved populations.
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s…
Novartis has announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.
Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.
BMS has published data showing treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels.
Bristol Myers Squibb (NYSE: BMY) has announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline.
Kite, a Gilead Company (Nasdaq: GILD), has announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Achieving classical herd immunity against SARS-CoV-2, the virus that causes COVID-19, may not be attainable, according to a new perspective published in The Journal of Infectious Diseases.
Abzena Thrusday announced a new round of investment. Funding sources for the additional $65 million include majority-owner Welsh, Carson, Anderson & Stowe (WCAS), Biospring Partners, and other affiliated investors.