Category Archives: R&D

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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Pharma Report Predicts Trillion Dollar Global Industry by 2020

By Colin McMahon. EvalutePharma’s seventh edition of its World Preview documents that worldwide prescription drug sales forecast will exceed the one trillion dollar mark by 2020. The company bases this estimate on the growing compound annual growth rate (CAGR) that the pharmaceutical industry is currently enjoying. It predicts that CAGR will continue to grow through […]
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What Drives Patient Interest in Clinical Trials?

By Fred Gebhart. Recruiting patients remains one of the most difficult challenges clinical trial sponsors face. Recognizing that fewer than five percent of eligible adult patients enroll in therapeutic trials, many sponsors have turned to supplemental recruitment, the practice of pre-qualifying community-based patients for referral to clinical trial sites for screening. “The primary reason that […]
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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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