Wednesday, January 6, 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.
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).
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.
The FDA has approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving those cancer treatments.
Genentech, a South San Francisco-based member of the Roche Group, has announced that the FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.