Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Cellectis (Alternext: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
A lower dose formulation of Bayer and Janssen’s bloodthinner Xarelto has been approved by European regulators for preventing recurrent venous thromboembolism, expanding treatment options for patients.
Cancer cells are relentless, possessing the vexatious ability to develop resistance to current therapies and making the disease hugely challenging to treat. However, an exciting new study may have identified cancer's weak spot; the discovery has already led to the near-eradication of the disease in cell cultures.
Moderna Therapeutics today announced a new license and collaboration with AstraZeneca to co-develop and co-commercialize a messenger RNA (mRNA) therapeutic encoding for Relaxin. The companies will advance the new Relaxin development candidate, AZD7970, toward the clinic as an investigational treatment for heart failure.
Precision Medicine in oncology, where genetic testing is used to determine the best drugs to treat cancer patients, is not always so precise when applied to some of the world's more diverse populations, according to a study led by the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, and the Keck School of Medicine of the University of Southern California (USC).
A vaccine combining centralized ancestral genes from four major influenza strains appears to provide broad protection against the dangerous ailment, according to new research by a team from the Nebraska Center for Virology.
In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
A venture capital firm in the Netherlands — backed by some big names in Big Pharma — has raised $95 million in a new fund to fuel European biotech startups.
Grail, the cancer detection start-up backed by tech giants Alphabet and Amazon, is already seeking new funding, mere months after it closed a $900 million round in March. The company had previously raised $100 million in 2016.
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