United States

Janssen Biotech submits stelara approval application for plaque psoriasis

Monday, December 19, 2016

Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.

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FDA accepts Bayer’s sBLA for myBETAapp and BETACONNECT Navigator

Thursday, December 15, 2016

Bayer has announced that the FDA has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECTNavigator. MyBETAapp is intended for patients taking BETASERON (interferon beta-1b), to help them record their treatment information such as drug injections and injection sites. The BETACONNECT Navigator is a tool that enables healthcare professionals the ability to review injection history for their patients.

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GSK opens new global vaccines R&D center in Rockville, Maryland

Tuesday, December 13, 2016

GlaxoSmithKline will inaugurate its newest global vaccines research and development (R&D) center in Rockville, Maryland, further strengthening and expanding its vaccines presence in the USA. Up to 200 new jobs will be created at the Rockville facility, with GSK investing over $50 million in the next two years to continue to develop the site with latest state-of-the-art scientific research technology and equipment.

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Major General James Gilman, M.D., to lead NIH Clinical Center

Monday, December 12, 2016

NIH Director Francis S. Collins, M.D., Ph.D., has announced the selection of Major General James K. Gilman, M.D., U.S. Army (Retired), as the inaugural chief executive officer of the NIH Clinical Center, the nation’s largest hospital devoted to clinical research. Dr. Gilman is expected to join in early January 2017.

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Epizyme receives Fast Track for Tazemetostat in B-cell lymphoma

Tuesday, November 29, 2016

Epizyme, a clinical-stage biopharmaceutical company creating novel epigenetic therapies, has announced advancements in the company’s clinical programs evaluating tazemetostat, its first-in-class EZH2 inhibitor. The FDA has granted tazemetostat Fast Track designation in patients with diffuse large B-cell lymphoma (DLBCL) with EZH2 activating mutations. Additionally, Epizyme is focusing its phase II registration-enabling study in adult patients with genetically-defined solid tumors on those cancers marked by loss of INI1, and has expanded enrollment in the epithelioid sarcoma cohort of the study based on encouraging early activity in this patient population.

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