A U.S. appeals court on Aug. 26 threw out a $1.2 billion ruling against Gilead Sciences Inc., finding a patent on a cancer therapy the company was accused of infringing was invalid, in a blow to rival Bristol Myers Squibb Co.
The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The IPO train continues to barrel down the tracks as more life sciences companies announced and closed their initial public offerings, bringing millions more to their coffers.
China welcomed the first CAR T-cell therapy in the country following approval from the National Medical Products Administration.
Harbour BioMed and Dana-Farber Cancer Institute struck a research collaboration deal to co-develop various novel cancer biotherapies, including CAR-T cell products and bispecific antibodies.
Med Ad News talked to Wendbush Securities analysts David Nierengarten, Laura Chico, and Liana Moussatos about various new drug approvals and other recent news updates in the industry.
The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
Based in South San Francisco, Lyell Pharmaceuticals filed for an initial public offering (IPO) with plans to raise $150 million. The preclinical biotech raked in $493 million in a Series C round on March 12, 2020.
Burlingame, California-based Humanigen reported positive data from the company’s Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). Lenzilumab is being investigated for the drug compound’s ability to tamp down the hyper-immune response known as a cytokine storm.
Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).