Global News

EMA releases data integrity guidance

Monday, August 15, 2016

The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

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ICER addresses misconceptions about value assessment goals and methods

Monday, August 15, 2016

The Institute for Clinical and Economic Review (ICER) has released a new publication to support the ongoing public conversation about its goals and the methods for evaluating the value of new drugs, devices, and other health system innovations. This publication, “Addressing the Myths About ICER and Value Assessment,” answers questions about ICER’s history, mission and methods while addressing misperceptions that may impede the kind of collaboration that is at the heart of ICER’s work.

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Mallinckrodt to acquire Stratatech

Monday, August 15, 2016

Mallinckrodt, a global specialty pharmaceutical company, has entered into a merger agreement with Stratatech, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. Financial terms of the transaction were not disclosed.

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ClinCapture appoints Scott Weidley chief executive officer

Friday, August 12, 2016

ClinCapture has appointed Scott Weidley as chief executive officer and member of the Board of Directors effective August 1, 2016. The appointment of Weidley, a cloud software executive specializing in electronic data capture (EDC), emphasizes a focus on customer-centric culture to drive product and business development for the brand.

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