2015

Amgen, LabCentral to support life sciences and biotech startups in Massachusetts

Monday, January 5, 2015

Amgen has become a LabCentral platinum sponsor. LabCentral is an innovative, shared laboratory space designed as a launchpad for life sciences and biotech startups. As part of the sponsorship agreement, Amgen can nominate up to two promising life sciences and biotech startup companies per year to take up residence in LabCentral’s Kendall Square facilities, based in Cambridge, Mass.

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Amgen, Kite Pharma form cancer immunotherapy collaboration

Monday, January 5, 2015

Amgen and Santa Monica, Calif.-based Kite Pharma have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite’s engineered autologous cell therapy (eACT) platform and Amgen’s extensive array of cancer targets.

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TxCell, Ferring collaborate on Ovasave

Monday, January 5, 2015

TxCell, a biotechnology company developing personalized T cell immunotherapies for severe chronic inflammatory and autoimmune diseases, is collaborating with Ferring International Center on the development of TcCell’s lead product Ovasave for the treatment of inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France.

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PPD, SNBL form Japanese clinical development joint venture

Monday, January 5, 2015

Pharmaceutical Product Development (PPD), a global CRO based in Wilmington, N.C., and Japan-based Shin Nippon Biomedical Laboratories (SNBL) have formed a joint venture to provide a full range of clinical development services in Japan, including phase I-IV clinical trial monitoring, project management, site intelligence and activation, biostatistics, data management, medical writing, pharmacovigilance, regulatory and FSP services.

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Regulatory Update, January 2015

Thursday, January 1, 2015

FDA draft guidance for laboratory developed tests

The FDA has announced availability of a draft guidance titled Framework for Regula­tory Oversight of Laboratory Developed Tests (LDTs). This document describes a risk-based framework for addressing the regulatory over­sight of a subset of in vitro diagnostic (IVD) devices called LDTs, intended for clinical use and designed, manufactured and used within a single laboratory. This document describes the FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which the FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time.

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