May 2017

Eisai, Johns Hopkins extend drug discovery collaboration

Wednesday, May 31, 2017

Eisai Inc., the U.S. pharmaceutical subsidiary of Tokyo, Japan-based Eisai Co., Ltd., and  Johns Hopkins University have extended their drug discovery collaboration through an exclusive licensing agreement. The agreement is for a license of compounds identified from collaborative research between Eisai’s Andover Innovative Medicines (AiM) Institute in Andover, Mass., and Johns Hopkins Drug Discovery (JHDD). The compounds were the outcome of research carried out in the laboratory of Professor Barbara Slusher Ph.D., MAS, Professor of Neurology, Neuroscience, Psychiatry, Medicine and Oncology at Johns Hopkins and the Director of JHDD, and is part of a broader ongoing collaborative research arrangement between Eisai and Johns Hopkins that is designed to translate new target discoveries into novel small molecule therapeutics for the development of medicines for neurology and oncology.

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Merck receives FDA approval of new HIV-1 treatment

Tuesday, May 30, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.

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Coordinating effective contingency training plans

Tuesday, May 30, 2017

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The call to participate in clinical research is transforming for patients, practitioners and research staff. Effectively executed drug studies can result in life changing therapies that level the playing field of human illness.

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Funders and NGOs find new reporting standards favorable

Tuesday, May 30, 2017

According to the World Health Organization (WHO), some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) recently agreed on new standards for clinical trials outcomes. Funded all clinical trials, per these new standards, are required to be registered with all results publicly disclosed. By all indications, funders and NGOs who agreed to the new standards find the new requirements favorable.

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Three Questions: David Izard, Chiltern

Tuesday, May 30, 2017

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Sony Salzman spoke with David Izard, senior director, Clinical Data Standards at Chiltern. He co-authored the white paper “The Case For Embracing The FDA’s Endorsed Data Standards.”

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