Author Archives: Jill Wechsler

Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the […]
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NIH Translational Research Partnership Yields Promising Therapy

A potential treatment for sickle cell disease has come through the “valley of death” of early stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The results of early clinical trials demonstrated sufficient effectiveness in addressing the underlying […]
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Industry Seeks Clearer Track-and-Trace Standards

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler. Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA […]
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Experts Tell Congress How to Streamline Clinical Trials

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up […]
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Will the Supreme Court Spur OTC Contraceptive Development?

One piece of fall-out from the recent Hobby Lobby decision by the U.S. Supreme Court is to generate talk of Republicans backing development of a nonprescription contraceptive pill. Conservative commentators supported this strategy as a way for Republicans to deflect Democratic charges of a GOP “war on women” and access to safe and effective birth […]
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