United States

Takeda appoints new president of U.S. business unit

Thursday, April 16, 2015 03:11 PM

Takeda Pharmaceutical has appointed Ramona Sequeira as president of the U.S. business unit. In this role, Sequeira will lead all business operations for the U.S., and will report to Christophe Weber, the president and CEO of Takeda.

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Quest Diagnostics

Reata Pharmaceuticals receives Orphan Drug Designation for Bardoxolone Methyl

Thursday, April 16, 2015 02:42 PM

The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for Reata Pharmaceuticals’ bardoxolone methyl for the treatment of pulmonary arterial hypertension (PAH). PAH is a life-threatening disease involving endothelial dysfunction, pulmonary vasoconstriction, vascular remodeling, pulmonary fibrosis and right ventricular hypertrophy. Additionally, PAH involves skeletal muscle dysfunction that contributes to the exercise intolerance observed in PAH patients. In preclinical studies, bardoxolone methyl has demonstrated potent antioxidant, anti-inflammatory, and bioenergetic properties, which may lead to improved exercise tolerance in patients.

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FDA modifies partial clinical hold on Tekmira's TKM-Ebola IND

Thursday, April 16, 2015 02:33 PM

The FDA has notified Tekmira Pharmaceuticals, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV) headquartered in Vancouver, BC, Canada, that the partial clinical hold on the company's Investigational New Drug application (IND) for TKM-Ebola has been modified to permit repeat dosing of healthy volunteers at a dose of 0.24mg/kg/day. The IND remains on partial clinical hold with regard to doses above 0.24mg/kg/day in healthy volunteers.

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IBM launches Watson Health Cloud, partners with Johnson & Johnson, Medtronic and Apple for personal health

Tuesday, April 14, 2015 11:51 AM

IBM is establishing a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions. 

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NIH, South African Medical Research Council award $8M in HIV, TB grants

Monday, April 13, 2015 12:23 PM

The NIH and the South African Medical Research Council (SAMRC) are awarding 31 grants to U.S. and South African scientists to support research targeting HIV/AIDS, tuberculosis and HIV-related co-morbidities and cancers.

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FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Thursday, April 9, 2015 02:20 PM

The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.

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Oramed enrolls first patient in glucose clamp study for oral insulin

Friday, April 3, 2015 10:22 AM

Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has enrolled the first patient in its glucose clamp study. The study will be performed at the University of Texas Health Science Center at San Antonio and University Health System's Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.

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Douglas Lowy named acting director of the National Cancer Institute

Friday, April 3, 2015 10:12 AM

Douglas Lowy, M.D., has been named the National Cancer Institute’s acting director. NCI is one of the 27 institutes and centers that comprise the NIH. Lowy has worked as NCI’s deputy director since July 2010, helping lead NCI’s key scientific initiatives since that time.

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NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015 01:08 PM

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

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PRC Clinical updates management, launches east coast operations

Friday, March 27, 2015 11:54 AM

PRC Clinical, a Silicon-Valley-based CRO, has announced several management and executive appointments effective immediately. Mike Catelani will assume the role of chief financial officer and member of the board of directors. Daniel Head has been appointed to vice president of business operations, and Sue Dowden will assume the position of senior director of clinical operations. Tony Taricco, co-founder and current chief operations officer, has been appointed president and chairman of the board of directors.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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