FDA

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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Warp Drive Bio to combat multi-drug-resistant bacterial infections

Tuesday, October 17, 2017

Warp Drive Bio, a drug discovery company developing therapeutics that exploit the molecules and mechanisms of nature, has formed a strategic collaboration with Roche to discover and develop multiple novel classes of antibiotics. The serious global health threat of multi-drug-resistant bacterial infections has created an urgent need for new antibiotics with novel structures and mechanisms of action.

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H3 granted orphan designation for hepatocellular carcinoma treatment H3B-6527

Wednesday, October 11, 2017

H3 Biomedicine, a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, announced that the FDA has granted the company an orphan drug designation for H3B-6527, its first solid tumor clinical compound, for the treatment of patients with Hepatocellular Carcinoma (HCC). H3B-6527, a selective, orally bioavailable, and potent covalent inhibitor of fibroblast growth factor receptor 4 (FGFR4), is currently in phase I clinical trials.

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FDA to modernize digital health software regulatory framework

Tuesday, October 10, 2017

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S. The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily the product.”

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CTTI takes on site investigator turnover in new recommendations

Friday, October 6, 2017

The Clinical Trials Transformation Initiative (CTTI) unveiled new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.

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