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EU Court Suspends EMA Decision to Grant Access to Drug Data
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Cristiana Spontoni, September 24, 2015
On September 1, 2015, the European General Court granted an interim order in favor of Pari Pharma, temporarily suspending the operation of a decision by the European Medicines Agency ("EMA") to allow Novartis Europharm to gain access to reports on Pari Pharma's drug Vantobra under the...
FDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars
Edgar J. Asebey,Maureen Bennett,Colleen Heisey,Janet M. McNicholas,Christian Paul, September 11, 2015
On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...
FDA Updates List of Tropical Diseases Eligible for Award of Priority Review Voucher
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Cristiana Spontoni, September 4, 2015
In a final order issued August 20, 2015, FDA updated the list of tropical disease products eligible to receive a priority review voucher ("PRV"), an incentive to encourage the development of new drugs for the prevention or treatment of certain diseases by providing priority review of a...