Latest News
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12 March 2013
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The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug
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Latest News
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18 December 2012
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The European Medicines Agency (EMA) has opened a new consultation on a draft guideline that would revise a set of biosimilar guidelines first put in place six years ago.The guideline, On non-clinical
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Latest News
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24 September 2012
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Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of
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Regulatory Update
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20 June 2012
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The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a speech delivered by Health and Consumer Policy
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Latest News
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2 May 2012
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The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers
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Latest News
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2 May 2012
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A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells,
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Latest News
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28 March 2012
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An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for
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