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April 8, 2014
09:27 EDTHSPHospira sent FDA warning letter over inspection of device facility
In a warning letter sent to Hospira, dated March 7, that was posted to the agency's website, the FDA stated that an inspection of the company's Rocky Mount, NC facility on September 30 to November 15, 2013 revealed adulterated devices. Reference Link
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April 24, 2015
05:43 EDTHSPHospira announces new white paper extrapolation
Hospira announced the publication of a pivotal white paper titled, "Why extrapolation is paramount to achieving the full promise of biosimilars." The white paper highlights the significance of extrapolation in the development of a successful and sustainable biosimilars market. Real-world cost savings and increased patient access to life-saving medicines can be achieved by conducting only scientifically necessary clinical trials, it states, while also calling for more regulatory agencies to adopt the principle of extrapolation. In the white paper, Ramachandra notes that the scientific principle for extrapolation has already been adopted by the European Medicines Agency, or EMA, and that the European Commission, or EC, has approved 21 biosimilar medicines in Europe, including the first biosimilar monoclonal antibody, Inflectra, in September 2013. In addition, the FDA utilized extrapolation to approve the first biosimilar in the United States, biosimilar filgrastim, last month for all the therapeutic indications of the reference product that were available at that time.
April 20, 2015
07:02 EDTHSPEagle Pharmaceuticals price target raised to $75 from $55 at Piper Jaffray
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April 15, 2015
07:41 EDTHSPEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.

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