Drug Shortages in Generic Injectables: Solving the Quality Issue

ERIN O'BRIEN | February 18, 2014

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Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult.

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Purdue Pharma L.P. is a privately held pharmaceutical company founded by physicians more than 60 years ago. We are committed to advancing the care of patients with innovative, quality products that make a positive impact on healthcare — and on lives.

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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Roche Prepares to Launch COVID-19 Antibody Test System

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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Pfizer Won’t Win the Coronavirus Pharma War

Article | March 6, 2020

Shares of Pfizer jumped more than 6% on Wednesday, after the company announced a plan to test some of its antiviral products as a potential treatment for the coronavirus from China. More than 35 million shares traded on the news — about 48% more than normal — as investors looked for any positive news from the pharma community after the recent selloff. So, does this mean that Pfizer stock is turning the corner?

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Clinical Supply Availability & Speed to Study Start-Up

Article | March 26, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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Purdue Pharma L.P.

Purdue Pharma L.P. is a privately held pharmaceutical company founded by physicians more than 60 years ago. We are committed to advancing the care of patients with innovative, quality products that make a positive impact on healthcare — and on lives.

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