Wednesday, October 7, 2015
The Simplexa Flu A/B & RSV Direct Kit from Cypress, Calif.-based Focus Diagnostics—the products business of Madison, N.J.-based Quest Diagnostics—has received 510(k) clearance from the FDA for 46 additional influenza A and influenza B virus strains and seven additional respiratory syncytial virus (RSV) strains.
The FDA has granted Accelerated Approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.
The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.
The NIH Common Fund has awarded more than $54 million in fiscal year 2015 to launch projects in four broad scientific areas: the Glycoscience Program, the 4D Nucleome Program, the Gabriella Miller Kids First Research Program and the Science of Behavior Change Program. The Common Fund planning process identifies major challenges that impede progress in research and emerging areas of science that promise to change the way people think about health and disease or the way prevention or treatment is approached. Common Fund programs that emerge are goal-driven, with deliverables expected within a five to 10 year period. The 2015 awards represented first-year funding of a multiyear program.
Prometheus Research has been awarded more than $250,000 from the NIH to transform the way electronic data capture (EDC) forms are configured, integrated and shared for biomedical and behavioral health research. The grant, part of NIH’s Small Business Innovation Research (SBIR) program, seeks to empower mental health researchers to easily share, reuse and locate electronic data capture forms across a variety of EDC platforms.
The Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1 million base contract with future options totaling $5.2 million to support various development activities of the investigational rVSV-ZEBOV (Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck.
The NIH has awarded 13 grants to research institutions around the country as part of a study about the effects of adolescent substance use on the developing brain. The Adolescent Brain Cognitive Development (ABCD) Study will follow about 10,000 children beginning at ages 9 and 10, before they initiate drug use, through the period of highest risk for substance use and other mental health disorders. Scientists will track exposure to substances (including nicotine, alcohol and marijuana), academic achievement, cognitive skills, mental health and brain structure and function using advanced research methods.