Tag Archives: Sandoz

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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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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FT Healthcare Conference: Society as Stakeholder

Speakers at the 2nd annual Financial Times US Healthcare and Life Sciences conference in New York last week discussed the cost of health, and the implications of an increasingly vocal and influential stakeholder group: the local populace. After opening remarks from Andrew Jack, FT’s prolific pharmaceuticals correspondent, Pfizer CEO Ian Read took the stage at […]
Posted in Europe, Events, Global, healthcare, leadership, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Strategy, Technology | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

Woodcock Under Investigation

Image by Getty Images via Daylife An FDA director has come under fire by a generics firm claiming that the director of the Center for Drug Evaluation and Research favored a competitor in a wanton act of conflict of interest. The Wall Street Journal this morning broke the story that Janet Woodcock is under investigation […]
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