Tag Archives: FDA

Breakthrough Drug Initiative Success Creates Manufacturing Challenges

The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, […]
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What’s All This Talk About Patient Centricity?

For Moe Alsumidaie, the most concrete definition for patient centricity is “a dynamic process through which the patient regulates the flow of information to and from him/her via multiple pathways to exercise choice that is consistent with his/her preferences, values and beliefs. This fundamentally transformative concept affects how healthcare decisions are made and who has […]
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FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez. The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs […]
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Amgen and Sandoz in Legal Battle Over Biosimilar Application

By Randi Hernandez In a landmark lawsuit over the first biosimilar application, Amgen is suing Sandoz for unlawfully refusing to follow the patent resolution protocol laid out by the rules of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
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Legislators Urge Added Incentives for Ebola Drug Development

Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the Food and Drug Administration as an incentive for biopharma companies to invest in treatments for this deadly disease. The priority review voucher (PRV) program for neglected tropical diseases (NTDs) currently applies to 16 deadly conditions […]
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