Weekly Features

GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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Principal investigator charged for insider trading

Monday, August 15, 2016

It’s rare for a principal investigator (PI) to face insider trading charges based on confidential developments in a clinical trial. But earlier this month, Edward J. Kosinski, M.D., a PI and president of Connecticut Clinical Research, was indicted on two counts of securities fraud by a federal grand jury in Connecticut for allegedly trading shares of Regado Biosciences in 2014 after receiving non-public information about the clinical trial from the project manager.

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GSK and Verily’s Galvani Bioelectronics forges ahead, ushering in a new era of medicine

Monday, August 8, 2016

Galvani Bioelectronics, a newly established company launched by GlaxoSmithKline (GSK) and Verily Life Sciences (formerly Google Life Sciences), will explore a new wave of science. Galvani Bioelectronics will focus on the development of bioelectronic medicine: the use of implantable devices to modify the electrical signals that nerve cells use to communicate within the body.

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EMA proposes changes to first-in-human trials spurred by January’s Bial trial deaths

Monday, August 1, 2016

Are the risks faced by phase I clinical trial participants too great? The European Medicines Agency (EMA), the European Commission and the Member States of the European Union (EU) believe so. Together, they’re proposing changes to current guidance on first-in-human clinical trials that would, if successful, improve strategies for identifying and mitigating risks to study subjects.

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