United States

Endo drops abuse deterrent labeling for OPANA ER

Monday, August 15, 2016

Endo International has announced that, based on an August 11, 2016 discussion with the FDA, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA ER without prejudice to re-filing. The company plans to continue collecting and analyzing epidemiological data relating to OPANA ER. Endo’s financial projections for 2016 did not assume approval of the sNDA.

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FDA grants Rare Pediatric Disease Designation to Regenxbio’s RGX-121 Gene Therapy

Wednesday, August 3, 2016

REGENXBIO, a biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV Technology Platform, has announced that the FDA has granted Rare Pediatric Disease Designation to RGX-121, REGENXBIO’s investigational gene therapy product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II).

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NIH funds precision medicine research with a focus on health disparities

Friday, July 29, 2016

The National Institute on Minority Health and Health Disparities (NIMHD), part of the NIH, has committed approximately $31 million over five years, pending available funding, to launch a new program for Transdisciplinary Collaborative Centers (TCCs) for health disparities research exploring the potential for precision medicine to promote health equity and advance the science of minority health and health disparities.

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