United States

FDA accepts Lundbeck resubmission of NDA for Carnexiv (carbamazepine)

Monday, April 25, 2016

The FDA has accepted for review the resubmission of Lundbeck’s New Drug Application (NDA) for intravenous Carnexiv, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2016. Lundbeck’s resubmission was in reply to the Complete Response Letter from the FDA issued in 2014 requesting additional data associated with the Chemistry, Manufacturing and Controls (CMC) of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.

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Cancer Centers, biopharmaceuticals collaborate on precision medicines

Wednesday, April 20, 2016

M2Gen, a healthcare informatics solutions company, has announced a collaboration with pharmaceutical companies and the Oncology Research Information Exchange Network (ORIEN), an alliance of cancer centers throughout the U.S. M2Gen also announced that Celgene will be the industry’s founding member of a network of participants joining in this new initiative. The launch of the ORIEN Avatar Research Program brings together the pre-eminent players in healthcare R&D pharmaceutical companies and academic cancer centers to find new treatments for millions of Americans battling advanced-stage cancers.

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Study: U.S. drug spending growth reaches 8.5% in 2015

Monday, April 18, 2016

Total spending on medicines in the U.S. reached $310 billion in 2015 on an estimated net price basis, up 8.5% from the previous year, according to a new report issued by the IMS Institute for Healthcare Informatics. The surge of new medicines remained strong last year and demand for recently launched brands maintained historically high levels. The savings from branded medicines facing generic competition were relatively low in 2015, and the impact of price increases on brands was limited due to higher rebates and price concessions from manufacturers. Specialty dug spending reached $121 billion on a net price basis, up more than 15% from 2014.

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Veteran Affairs, Seven Bridges partner on Million Veteran Program

Monday, April 11, 2016

Seven Bridges, a biomedical data analysis company, has signed a Collaborative Research and Development Agreement (CRADA) with the U.S. Department of Veteran Affairs (VA) to support two key research initiatives for the VA’s Million Veteran Program (MVP). The MVP is a national, voluntary research program funded by the VA’s Office of R&D, with the goal of partnering with Veterans receiving their care from the VA Healthcare System to study how genes affect health. Seven Bridges will serve as an industrial collaborator on the MVP, supporting the development of a hybrid cloud for large-scale data analysis, and a genotype-phenotype graph analysis engine.

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INC Research, CISCRP collaborate on patient awareness

Wednesday, April 6, 2016

INC Research Holdings, a global phase I to IV CRO, has announced a strategic collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process. Through this collaboration, INC and CISCRP will jointly develop and implement educational initiatives designed to bring greater awareness to the importance of clinical trial participation in advancing public health.

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