Clinical Intelligence

Burst Biologics initiates multicenter study in spinal fusion

Wednesday, March 29, 2017

Burst Biologics has received IRB approval to begin a multicenter prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has shown very promising results in spinal fusion procedures. Fifteen clinical sites will participate throughout the U.S., with a total enrollment of 450 patients.

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Humacyte receives FDA RMAT designation for Humacyl in vascular access for hemodialysis

Monday, March 27, 2017

Humacyte, an innovator in biotechnology and regenerative medicine, announced that the FDA has granted Humacyl, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of the HAV for vascular access to patients in need of life-sustaining hemodialysis. Carved from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products.

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FDA grants Breakthrough designation for Rituxan (Rituximab) in pemphigus vulgaris

Friday, March 24, 2017

Genentech, a member of the Roche Group, has announced that the FDA granted Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. Genentech is currently enrolling a phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options. 

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NantKwest granted FDA Orphan Designation for aNK natural killer cell therapy in merkel cell carcinoma

Monday, March 20, 2017

NantKwest, a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, announced that the FDA has granted Orphan Drug Designation to the company’s activated natural killer (aNK) cell therapy for treatment of patients with advanced Merkel cell carcinoma.

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