Documents by this lawyer on Martindale.com
U.S. Reaches One of the Largest Trade Agreements in History: the TPP
Edgar J. Asebey,Jonathan Berman,Colleen Heisey,Katherine M. Llewellyn,Cristiana Spontoni, October 28, 2015
On October 6, 2015, after five years of negotiations, the U.S. closed the Trans-Pacific Partnership ("TPP") deal with Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam. According to Agriculture Secretary Tom Vilsak, "[T]he agreement...
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On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name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...