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Documents by Lawyers at this office
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 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...
EU Court Considers Antitrust Liability for Failing to React to Third Party Actions
Alan Davis,Yvan N. Desmedt,Matt Evans,Alexandre G. Verheyden, July 31, 2015
An advisor to Europe's highest court, the Court of Justice of the European Union ("CJEU"), is encouraging the CJEU to adopt a strict standard for companies to distance themselves from potentially anticompetitive actions by a third party with which they do business. In a case involving...
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