2014

PPMD calls for greater transparency, accountability of FDA patient engagement efforts

Wednesday, December 10, 2014

Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.

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Vital Connect, Medidata partner on continuous vital sign monitoring

Wednesday, December 10, 2014

Silicon Valley-based Vital Connect’s FDA-cleared wearable biosensor, HealthPatch MD, now is available for use in clinical trials in partnership with Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences. HealthPatch MD can be used with Medidata’s technology platform, Medidata Clinical Cloud, and its mobile app for patient-reported outcomes, Medidata Patient Cloud, to further remote patient monitoring, which has the potential to make clinical trials more efficient.

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Takeda renames Millennium as Takeda Oncology

Wednesday, December 10, 2014

Takeda Pharmaceutical has announced its global oncology business unit, headquartered in Cambridge, Mass., now will be called Takeda Oncology. The creation of Takeda Oncology will improve the company’s ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology R&D, while expanding its global commercial network and resources as Takeda Oncology.

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PCORI, NIH request applications to study blood pressure control

Wednesday, December 10, 2014

The NIH, as part of a research partnership with the Patient-Centered Outcomes Research Institute (PCORI), has issued a request for applications (RFA) to study how to improve blood pressure control among populations at highest risk for suffering hypertension-related strokes, heart attacks and other cardiovascular events. PCORI is a Wash. D.C.-based independent nonprofit organization authorized by Congress.

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Medidata releases Patient Profiles consulting service

Wednesday, December 10, 2014

Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, has made available its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a methodology for reducing trial costs while providing clinical data accuracy and quality.

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Report: Type 2 diabetes population to expand in China

Wednesday, December 10, 2014

For the treatment of type 2 diabetes in China, patient access to premium-priced agents is impeded as not all patients can afford these drugs, Burlington, Mass.-based Decision Resources Group has found. The National Reimbursement Drug List was last updated in 2009, and several antidiabetic drug classes (e.g. DPP-IV inhibitors and GLP-1 receptor agonist) are not covered, as they were only approved for use in China after 2009.

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