2016

Evotec, Celgene collaboration for neurodegenerative diseases

Friday, December 16, 2016

Evotec and Celgene have entered into a strategic drug discovery and development collaboration to identify disease-modifying therapeutics for a broad range of neurodegenerative diseases. Initial disease areas of focus will include Amyotrophic lateral sclerosis, Alzheimer’s disease, Parkinson’s disease, and multiple other neurodegenerative disorders.

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Commonwealth Informatics, FDA sign consultation agreement

Thursday, December 15, 2016

Commonwealth Informatics, a provider of clinical and safety analytics products and services, signed a new contract to support the use of advanced drug safety review tools at the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The focus of the agreement is for Commonwealth to support the expansion of the use of the analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance.

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CytomX to start phase I/II study of CX-072

Thursday, December 15, 2016

CytomX Therapeutics, a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, today announced that the FDA has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer. The company plans to immediately initiate the study and open clinical sites to support patient enrollment.

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FDA accepts Bayer’s sBLA for myBETAapp and BETACONNECT Navigator

Thursday, December 15, 2016

Bayer has announced that the FDA has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapp and the BETACONNECTNavigator. MyBETAapp is intended for patients taking BETASERON (interferon beta-1b), to help them record their treatment information such as drug injections and injection sites. The BETACONNECT Navigator is a tool that enables healthcare professionals the ability to review injection history for their patients.

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Why is there such inefficiency in site selection?

Thursday, December 15, 2016

This question is often asked about an industry deeply root­ed in paper-based, spreadsheet tools for clinical trial conduct. Study teams have continued to rely on these older tools and relation­ships with principal investigators that have developed over time to select sites, building an institu­tional knowledge about specific sites based on previous studies.

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Theranos adds John McChesney and Tali Mackay

Tuesday, December 13, 2016

Theranos has announced that key roles have been filled in the company’s executive ranks, with the naming of John McChesney to senior vice president of operations and Tali Mackay to senior vice president of corporate communications and investor relations, as well as the promotion of David Taylor to the role of general counsel. Dr. Gregory J. Tsongalis was appointed to the company’s Scientific and Medical Advisory Board (SMAB).

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ACRES, BSI collaborate on clinical research sites standards

Tuesday, December 13, 2016

The Alliance for Clinical Research Excellence and Safety (ACRES), in partnership with the British Standards Institution (BSI), has launched a multi-stakeholder global working party to fast-track development of standards for all aspects of site work, laying the foundation for recognizing and rewarding excellence at clinical research sites worldwide and accelerating development of safe and effective new medicines.

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