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Results:1-10 of 31

Northern exposure?
  • Gowling WLG
  • USA, Canada
  • April 4 2013

Davit Akman and John Norman suggest that a recently commenced investigation into alleged "product switching" and statements by the Interim


Apotex alleges it is injured by Ranbaxy's ability to launch on schedule
  • Gowling WLG
  • USA
  • July 27 2009

In two different cases before the US District Court for the Middle District of North Carolina Apotex has alleged that Ranbaxy's inability to launch its generic versions of donepezil hydrochloride (sold by Eisai Co. under the brand Aricept) and valacyclovir hydrochloride (sold by GSK under the brand Valtrex) on time will injure Apotex.


Protection of biologics in the US
  • Gowling WLG
  • USA
  • July 27 2009

By a vote of 16 to 7, the U.S. Senate health committee approved a minimum period of 12 years before generic versions of biotech drugs can be approved.


FTC report on follow-on biologics
  • Gowling WLG
  • USA
  • June 24 2009

Earlier this month, U.S. lawmakers debated the key issue of the exclusivity period afforded to biologic drugs - those drugs manufactured using living tissue and micro-organisms.


FDA requires increased disclosure of bioequivalence studies for ANDA applicants
  • Gowling WLG
  • USA
  • February 9 2009

Effective July 15, 2009, the U.S. Food and Drug Administration (FDA) will require applicants of an abbreviated new drug application (ANDA) to submit all data from bioequivalence studies that have been conducted on the particular drug formulation submitted for approval.


Patent misuse in the pharmaceutical industry: developments in US & EU
  • Gowling WLG
  • USA, European Union
  • October 31 2007

The pharmaceutical industry has been scrutinised closely by competition authorities and courts in the US and Europe.


U.S. FDA finds consumers continue to buy potentially dangerous drugs over the internet
  • Gowling WLG
  • USA
  • July 13 2007

On July 2, 2007, the FDA again warned consumers about the dangers of buying medications over the Internet.


Isabel Raasch
  • Gowling WLG

Scott E. Foster
  • Gowling WLG