United States

FDA approves CAR-T cell therapy for large B-cell lymphoma

Friday, October 20, 2017

The FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

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FDA grants Priority Review for Lynparza in metastatic breast cancer

Wednesday, October 18, 2017

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.

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FDA selects Box for cloud content management

Wednesday, October 18, 2017

Box announced that the FDA has selected Box’s cloud content management platform to modernize its technical infrastructure and drive new ways to work in the cloud. With Box, the FDA is furthering its IT innovation strategy to digitize business processes and envision new ways to engage with the pharmaceutical and life sciences industry.

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U.S. District Court issues Restasis patents trial decision

Wednesday, October 18, 2017

Allergan, a global biopharmaceutical company, acknowledged that the U.S. District Court for the Eastern District of Texas has issued an adverse trial decision finding that the four asserted patents covering Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% are invalid. The company will appeal the Court’s ruling.

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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Eli Lilly’s Verzenio grabs Priority Review for advanced breast cancer

Friday, October 13, 2017

Eli Lilly announced that the FDA has granted Priority Review designation for its New Drug Application (NDA) for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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