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7/28/2016

Researchers at the Albert Einstein College of Medicine, Columbia University Medical Center and Montefiore Medical Group received $3 million from the National Institute of Mental Health to help increase the use of pre-exposure prophylaxis to reduce HIV transmission in the Bronx borough of New York. The project includes the creation of a tool to identify high-risk individuals and use of EMRs to facilitate screening, monitoring and prescribing of pre-exposure prophylaxis and communication among patients and clinicians.

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Healthcare IT News
7/28/2016

About 8,800 pounds of raw beef products from North Haverhill, N.H.-based PT Farm are being recalled by the Department of Agriculture's Food Safety and Inspection Service due to suspected E. coli contamination that sickened 14 people. The beef products being recalled are raw, intact and nonintact subprimal cuts, ground beef and ground beef patties produced between June 6 to 16 that were sold to retailers and institutions in Massachusetts, Vermont, New Hampshire and Maine.

7/28/2016

Guidelines aiming to improve communication between pharmaceutical companies and health care professionals about drug products were issued by the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America, with a call to the FDA to clarify the types of information the biopharmaceutical firms are allowed to share, along with approved labels. The guidelines contain nine principles that focus on providing appropriate context about data, accurately representing data and commitments to science-based communications.

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Morning Consult
7/28/2016

The FDA sent a letter to Regulus Therapeutics outlining information required to resolve the clinical hold on its investigational new drug application for its lead candidate, RG-101. The firm plans to submit the requested data in the fourth quarter.

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Regulus Therapeutics, FDA
7/28/2016

Santhera Pharmaceuticals' application for accelerated approval of its Duchenne muscular dystrophy therapy Raxone has been rejected by the FDA because the agency said it needs data from a planned second trial to be able to evaluate the application. The company based its submission on a single late-stage study.

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FDAnews
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FDA, Santhera Pharmaceuticals, Raxone
7/28/2016

Glenmark Pharmaceuticals received FDA approval for potassium chloride extended-release tablets in 750- and 1500-mg strengths. The drug is a generic version of Merck's K-Dur extended-release tablets.

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India Infoline
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Glenmark Pharmaceuticals
7/28/2016

A clinical trial application to begin early-stage study of AZD8601 has been submitted by AstraZeneca to the German Federal Ministry of Health and the Paul Ehrlich Institute. The drug candidate is an mRNA-based therapy that produces vascular endothelial growth factor A, which can be used to treat serious cardiovascular, renal and metabolic diseases and cancer.

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PharmaBiz.com (India)
7/28/2016

Four new drugs have been accepted by the European Medicines Agency to its priority medicines program. The accepted drugs include Merck's Ebola Zaire vaccine; Novartis' CTL019, to treat relapsed or refractory B cell acute lymphoblastic leukemia in children; DNATrix's DNX-2401, for the treatment of recurrent glioblastoma in patients who are not suitable for total resection; and Adaptimmune's NY-ESO-1c259T, to treat inoperable or metastatic synovial sarcoma in patients with tumors expressing the NY-ESO-1 tumor antigen who have been previously treated with chemotherapy.

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Regulatory Focus
7/28/2016

Cytokinetics has granted Astellas Pharma an option to develop and market tirasemtiv in an expanded agreement that adds amyotrophic lateral sclerosis to their 2013 deal to research and develop skeletal muscle activators. The expanded partnership also allows for the development of CK-2127107 as a treatment for ALS and extends the firms' skeletal muscle activator research through 2017.

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Astellas Pharma, Cytokinetics, ALS
7/28/2016

Researchers from Cornell University have discovered a way to transform the industrial waste gas carbon monoxide into biofuel ethanol by using the bacterium Clostridium ljungdahlii in synthetic gas fermentation. The microbe responds thermodynamically to ferment carbon monoxide into ethanol, according to findings published in the journal Energy and Environmental Science.