United States

Kinex Pharmaceuticals appoints two to New Jersey clinical office

Wednesday, May 14, 2014 03:22 PM

Kinex Pharmaceuticals has announced the addition of two key executives to its clinical leadership team reporting to chief medical officer, Dr. Rudolf Kwan. Douglas Kramer, M.D., joins Kinex as vice president of Clinical and Regulatory Affairs and Jane Devane has joined Kinex as director of Clinical Operations.

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WIRB Copernicus Group

Abeona Therapeutics receives FDA Orphan Drug Designations for Sanfilippo

Wednesday, May 14, 2014 02:54 PM

Abeona Therapeutics, a start-up company created around intellectual property licensed from Nationwide Children's Hospital to develop treatments for Sanfilippo Syndrome Types A and B, has been granted Orphan Drug Designations for its lead investigational therapies by the FDA Office of Orphan Products Development. Following the successful close of seed financing in late 2013, Abeona is raising funds to advance its gene therapy-based clinical programs for both Sanfilippo Syndrome type A and B. Phase I/II clinical trials for both diseases are anticipated to begin in 2014.

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CRF Health eCOA webinar series

UCLA receives $4 million from Eli and Edythe Broad Foundation

Wednesday, May 14, 2014 01:05 PM

Two new gifts from the Eli and Edythe Broad Foundation to UCLA totaling $4 million will fund research in stem cell science and digestive diseases and support the recruitment of key faculty at two research centers.

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FDA approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant)

Monday, May 12, 2014 12:35 PM

The FDA has approved a new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25IU/kg three times per week) or on-demand treatment.

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FDA approves Zontivity to reduce risk of heart attacks and stroke

Friday, May 9, 2014 12:50 PM

The FDA has approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

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Moffitt Cancer Center, Vermillion collaborate

Friday, May 9, 2014 12:32 PM

The Moffitt Cancer Center in Tampa, Fla., and Austin-based Vermillion have announced a research collaboration, launching a study to produce clinical and economic data to support a new value-based practice model that may improve survival, quality of life and cost-effectiveness of care for patients with ovarian cancer.

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FDA approves EPANOVA for severe hypertriglyceridemia

Wednesday, May 7, 2014 02:43 PM

AstraZeneca has announced the FDA approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).

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ACRP CCRC designation recognized by American Nurses Credentialing Center

Wednesday, May 7, 2014 01:34 PM

The Association of Clinical Research Professionals' (ACRP) Certified Clinical Research Coordinator (CCRC) designation now is recognized by the American Nurses Credentialing Center (ANCC) as a valid designation toward meeting staffing requirements of the ANCC Magnet Recognition Program.

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FDA approves WuXi’s manufacture of ibalizumab in China for use under a U.S. IND

Wednesday, May 7, 2014 01:32 PM

The FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product, manufactured at WuXi PharmaTech's biologics facilities and developed by TaiMed Biologics for the treatment of HIV/AIDS infection. 

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PhRMA: More than 100 medicines for mental health disorders in development

Wednesday, May 7, 2014 01:29 PM

America’s biopharmaceutical research companies currently are developing 119 novel new medicines to help improve the lives of the estimated 61.5 million Americans affected by mental health disorders, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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