Congress to Remove Key Safety Component of Imported Medicines

BEN FIRSCHEIN | May 3, 2016

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Did you know that most drugs sold in the United States are imported from countries like India and China? That might surprise most people. The key protection for U.S. consumers—that should be maintained for all drugs sold in the U.S.—is that manufacturers of those drugs must adhere to a full range of FDA requirements – including requirements for product quality set by the United States Pharmacopeia (USP)—a nonprofit public health organization that helps protect American consumers and patients through public standards for the quality of medicines.

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Kyowa Kirin International plc

At Kyowa Kirin International plc “Commitment to Life” is at our core. With over 500 people focused on this purpose we’ve become a highly successful and rapidly growing specialty pharmaceutical company engaged in the development and commercialization of innovative medicines for the treatment of unmet therapeutic needs in major western markets. Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth.

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

Article | April 11, 2020

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.

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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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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 4, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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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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Spotlight

Kyowa Kirin International plc

At Kyowa Kirin International plc “Commitment to Life” is at our core. With over 500 people focused on this purpose we’ve become a highly successful and rapidly growing specialty pharmaceutical company engaged in the development and commercialization of innovative medicines for the treatment of unmet therapeutic needs in major western markets. Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth.

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