United States

EMA, FDA reinforce collaboration on patient engagement

Tuesday, June 28, 2016

The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.

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PFS Clinical, Velos partner on clinical trial management

Friday, June 24, 2016

PFS Clinical, a division of PharmaSeek, has partnered with Velos to deliver a turn-key solution that enables research institutions to better manage their clinical trials. The pairing of Velos’ industry-leading clinical trial management system (CTMS) with PFS Clinical’s team of clinical trial administration experts provides the foundation to drive operational efficiencies, improve performance, alleviate financial risk and enhance process consistency in today’s quality-driven clinical research industry.

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CenterWatch joins WIRB-Copernicus Group

Wednesday, June 22, 2016

WIRB-Copernicus Group (WCG), one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, today announced its acquisition of CenterWatch, the leading provider of clinical trial industry news and information, and the addition of Kenneth A. Getz, CenterWatch founder and owner, to its board of directors.

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Cell Medica, Baylor partner on cancer treatments

Monday, June 20, 2016

Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, has announced a co-development partnership with Baylor College of Medicine to develop next-generation technologies for engineering immune cells with enhanced functions for the treatment of solid tumors. The collaboration provides Cell Medica with an exclusive license over several Baylor cell and gene technologies and an option to license new products introduced into the co-development partnership by Baylor’s leading research teams in the field of genetically engineered immune cells.

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Shire, Kamada announce FDA Emphysema treatment GLASSIA

Friday, June 17, 2016

Shire and Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training.

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