Category Archives: Biotech

Setting Biotech Standards in India

The past decade has seen considerable growth in the Indian pharmaceutical industry. The country has emerged as a key supplier of high quality and affordable medicines not only to the developing world, but also to developed economies. The sector has recorded a compound annual growth rate (CAGR) of 13.5% over the past five years and is […]
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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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Hemispherx’s Five Ebola Research Collaborations

Hemispherx Biopharma (Philadelphia, PA) has announced a  set of research collaborations designed to develop “therapeutic cocktails against Ebola which may potentially overcome the emergence of drug resistance due to Ebola virus mutation”.
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Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
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Healthcare Reform in China: A Doubled-Edge Sword for Foreign Firms?

The Chinese market is attractive to foreign investors for many reasons. It is the world’s third largest market for pharmaceuticals with annual sale of US$71 billion.  In fact, it is poised to become the second largest market in 2015 given that its annual growth rate of sales is between 15 and 20%, according to Yanzhong […]
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