Clinical trials – a rigorous framework for trial authorisation and patient safety monitoring

SINI ESKOLA | February 26, 2016

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Medicine development takes an average of 12 years until approval for use in patients. Clinical research is an essential part of the development process but it is also the lengthiest and most expensive.

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Correvio International Sàrl

Correvio International is a privately held pharmaceutical company located in Geneva, Switzerland. Correvio LLC, our global supply chain operation, is located in Chester, Pennsylvania, USA. Currently, we commercialise Aggrastat® (tirofiban HCl)* in more than 50 countries worldwide either directly (Europe) or via our distributor and partner network.

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WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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Over the past half-century, clinical trials have grown increasingly complex. A flood of new data from novel sources combined with more elaborate study designs and tougher regulatory standards have lengthened timelines and hiked costs, contributing to a steady decline of efficiency. It all adds up: Nearly half of all drug launches underperform revenue expectations. And if that isn’t enough, the outbreak of COVID-19 worldwide is having an effect on how life sciences companies operate their businesses, including how clinical trials are conducted. Most clinical trial research organizations have tried to adapt by tweaking a platform here, adding a new app there, but this has only yielded patchwork systems of sites, spreadsheets and dashboards that further burden the process.

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Article | April 17, 2020

Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system. Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly. Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies.

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Spotlight

Correvio International Sàrl

Correvio International is a privately held pharmaceutical company located in Geneva, Switzerland. Correvio LLC, our global supply chain operation, is located in Chester, Pennsylvania, USA. Currently, we commercialise Aggrastat® (tirofiban HCl)* in more than 50 countries worldwide either directly (Europe) or via our distributor and partner network.

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