United States

ACRES, ActivMed collaborate on site standards, sustainability

Monday, January 4, 2016

The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based nonprofit organization building a global system for clinical research, and ActivMed Practices & Research, a multi-specialty, free-standing research organization based in Massachusetts and New Hampshire, have announced a strategic alliance focused on enhancing quality and sustainability of clinical research sites.

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Regenxbio’s RGX-111 gets FDA Rare Pediatric Disease designation

Monday, January 4, 2016

Regenxbio, a Rockville, Md.-based biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today announced that the FDA has granted Rare Pediatric Disease designation to RGX-111, the company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis type I (MPS I).

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Minerva completes enrollment in MIN-101 phase IIb trial

Monday, January 4, 2016

Minerva Neurosciences, a Waltham, Mass.-based clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, has announced that the FDA has accepted the company’s Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia.

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