United States

NIH funds consortium for childhood oral health disparities research

Monday, September 21, 2015

The National Institutes of Health will award 10 research grants aimed at eliminating inequities in access to care and improving the oral health of children. Totaling more than $7 million in first-year funding, the awards support the Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children, a new initiative of NIH’s National Institute of Dental and Craniofacial Research (NIDCR).

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Nanomedical Diagnostics launches

Monday, September 21, 2015

Nanomed co-founders Ross Bundy and Dr. Brett Goldsmith have launched Nanomedical Diagnostics, a San Diego-based biotech company developing and commercializing bioelectronics for use in research and diagnostics. Nanomed’s first product, AGILE Research, a label-free, quantitative, low-cost biosensor for small molecule and protein analysis, is entering beta testing this fall and planned for commercial release in early 2016.

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Robert Califf seen as clinical research insider

Monday, September 21, 2015

Robert Califf, M.D., President Barack Obama’s nominee to be the next FDA commissioner and seen by some as a clinical research insider, is being called “a terrific choice” who is “very open to new ideas” by experts in the clinical trials sector.

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Undiagnosed Diseases Network launches online application portal

Thursday, September 17, 2015

The Undiagnosed Diseases Network (UDN), a clinical research initiative of the National Institutes of Health, has opened an online patient application portal called the UDN Gateway. Introduction of this application system sets the stage for the network to advance its core mission: to diagnose patients who suffer from conditions that even skilled physicians have been unable to diagnose despite extensive clinical investigation. These diseases are difficult for doctors to diagnose because they are rarely seen, have not previously been described or are unrecognized forms of more common diseases.

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Cesca Therapeutics restructures, cuts 15 jobs

Thursday, September 17, 2015

Cesca Therapeutics, an autologous cell-based regenerative medicine company, has undertaken a restructuring initiative geared toward reducing costs associated with its traditional cord blood banking business and further aligning available resources behind the company’s clinical programs, including the phase III pivotal clinical trial for no option critical limb ischemia (CLI) patients, recently approved by the FDA.

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Col-Treg gets FDA Orphan designation for uveitis

Monday, September 14, 2015

TxCell, a France-based biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced today that the FDA’s Office of Orphan Products Development has granted Orphan Drug designation to TxCell’s Col-Treg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of chronic non-infectious uveitis. The move followed the Orphan Drug designation already received for the product in Europe.

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