Thursday, June 4, 2015
Baxter Ventures, the Mayo Clinic and Velocity Pharmaceutical Development (VPD) have formed Vitesse Biologics. Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in immunology, hematology and oncology.
FDA draft guidance on acceptance of medical device clinical data from studies conducted outside the U.S.
Actavis’ Viberzi (eluxadoline) has been approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.
ORIG3N, a Boston-based biotechnology company, is collaborating with Laboratory Corporation of America Holdings (LabCorp), a healthcare diagnostics company. LabCorp has invested in ORIG3N and will provide storage for LifeCapsule, ORIG3N’s induced pluripotent stem cell (iPSC) storage, at its biorepository facilities as well as perform genetic testing on the stored cells. LabCorp’s experience will help to accelerate the development of LifeCapsule’s specimen repository.
The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.
Forum Pharmaceuticals, a biopharmaceutical company focused on the development and delivery of innovative medicines to treat serious brain diseases, has relocated its corporate headquarters to a 112,500-square-foot, state-of-the-art facility located in Waltham, Mass. The move consolidates Forum’s operations into a single centralized location that houses corporate offices, clinical development and research laboratories. Previously, Forum conducted business from two locations in Watertown, Mass. and Brighton, Mass. The company also maintains a small European office in the Netherlands.
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that the U.S. Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company’s SMART engine. The patent provides broad coverage for CluePoints’ proprietary methodology that supports a risk-based approach to data monitoring in clinical trials.