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Board follows guidelines in Penlac decision
  • Gowling WLG
  • Canada
  • February 7 2011

On February 3, 2011, the Patented Medicine Prices Review Board (the Board) released its decision dated January 31, 2011, regarding Penlac, a drug manufactured by sanofi-aventis.


First PMPRB decision dismissing allegations of excessive pricing
  • Gowling WLG
  • Canada
  • April 20 2010

The Patented Medicine Prices Review Board ("PMPRB") recently released its decision in the matter of Hoechst Marion Roussel Canada Inc. and the medicine NIOCODERM, a nicotine patch which assists those who are attempting to quit smoking; it is to be publicly posted on the PMPRB website today.


Toronto City Council adopts community right to know by-law
  • Gowling WLG
  • Canada
  • February 11 2009

On December 1, 2008, Toronto adopted an Environmental Reporting, Disclosure and Innovation Program.


FDA approves guidelines to inform doctors of "off-label uses" for medicine and medical devices
  • Gowling WLG
  • USA
  • January 19 2009

The United States Food and Drug Administration (FDA) recently finalized guidelines which will allow pharmaceutical companies to inform doctors about unapproved uses of medicines and medical devices.


FDA clinical trial regulations - "Sentinal System"
  • Gowling WLG
  • USA
  • May 29 2008

On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market.


EU expands antitrust inquiry of drug companies
  • Gowling WLG
  • European Union
  • May 29 2008

European antitrust regulators are continuing their inquiry into industry and corporate practices in the European pharmaceutical market.


OFT holds fire on new drug distribution model
  • Gowling WLG
  • United Kingdom
  • December 14 2007

This new trend has upset the old order.


Implemention of “Bolar” in the EU
  • Gowling WLG
  • United Kingdom, European Union
  • October 31 2007

In Europe, Directive 200427EC (amending Directive 200183EC) introduced into European Union legislation for the first time an exemption from patent infringement for conducting certain developmental work pre-patent expiry (the EU ‘Bolar’ exemption).


Pfizer Canada Inc. et al. v. Apotex Inc. et al.; 55.2 proceeding, decision on merits, prohibition granted, September 27, 2007 - sildenafil
  • Gowling WLG
  • Canada
  • October 4 2007

The Court granted an order prohibiting Apotex from obtaining a NOC until expiry of the patent in question.


PMPRB announces deferral of policy on compassionate release programs
  • Gowling WLG
  • Canada
  • June 11 2007

In a notice issued late Thursday, May 31, 2007, the PMPRB announced that it has decided not to proceed with implementation of a policy change, announced earlier in the month in its April 2007 NEWSletter, concerning the reporting of compassionate release programs and their impact on the calculation of the average transaction price (ATP) of a medicine for PMPRB purposes.