June 2015

Bracket acquires Clintara

Monday, June 29, 2015

Bracket Global, a provider of clinical research solutions, and Clintara, a privately held clinical service and technology company headquartered in Boston, Mass., have agreed to combine. Bracket will integrate the Clintara platform of surveillance strategies developed for clinical trials within Bracket’s proprietary electronic platform for Clinical Outcome Assessments (eCOA). The integration will include Clintara’s innovative C-VISA Subject Eligibility Validation program designed to ensure appropriate patients are enrolled in clinical trials.

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PharmaEngine receives FDA Priority Review, EMA MMA acceptance for MM-398

Monday, June 29, 2015

PharmaEngine has announced that its license partner, Merrimack Pharmaceuticals, has received FDA acceptance and Priority Review designation for their NDA and its sublicense partner, Baxalta, a wholly owned subsidiary of Baxter International, has received Market Authorization Application (MAA) from the EMA, of MM-398 (irinotecan liposome injection, also known as nal-IRI) in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

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DBV Technologies adds Dr. Hugh Sampson as chief scientific officer

Monday, June 29, 2015

DBV Technologies, a clinical-stage specialty biopharmaceutical company, has appointed Dr. Hugh Sampson chief scientific officer. In partnership with Dr. Dupont, chairman of the company’s scientific advisory board, Sampson will lead DBV’s research team, pursuing new Viaskin applications for the treatment of food allergies, while also supporting the company’s clinical development teams.

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Report: Venture financing in biotech follows male CEOs and boards

Monday, June 29, 2015

Gender still plays a role in biotech, with venture financing closely following male CEOs and all male boards, found Liftstream, a London-based company providing executive recruitment services to the biotechnology sector. Liftstream has published a new gender diversity report, Investing in Biotechnology Management, a study of venture financing and hiring trends in European and U.S. biotechnology companies and the gender representation on the boards and at the executive level. The research analyses 110 investment deals in private biotechnology companies as well as 308 biotech executive appointments.

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The critical elements of study startup

Monday, June 29, 2015

The Pulse on Site Success by Jeffrey Adelglass

The study startup phase has the lowest performance scores and the greatest variation in performance than any other stage of clinical trials.

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