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Results:1-10 of 18

Why combatting cyber-crime is critical for life science companies
  • Gowling WLG
  • USA
  • April 27 2017

Biotech and pharmaceutical firms hold vast amounts of valuable data and information making them prime targets for cyber-attacks - so how are they


Obama moving to renegotiate biologics exclusivity period
  • Gowling WLG
  • USA
  • January 20 2010

In the United States, biologics are not regulated under the Hatch-Waxman Act, which governs approval of conventional generic "small molecule" pharmaceuticals.


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.


5 - 5.5 growth projected for the global pharmaceutical market
  • Gowling WLG
  • USA, Global
  • January 19 2009

According to the National Association of Pharmaceutical Representatives (NAPRx), the global pharmaceutical market is expect to exceed $820 billion in 2009 growing by 4.5 - 5.5 percent.


Proposals for the approval of generic biologics under consideration
  • Gowling WLG
  • USA
  • February 28 2008

The budget proposed by President George W. Bush on February 4, 2008 included a new authority to approve generic biologics.


PDUFA reauthorization package clears first hurdle
  • Gowling WLG
  • USA
  • October 4 2007

The United States' House of Representative recently passed the authorization of the Prescription Drug User Fee Act (PDUFA).


Josh Hanet
  • Gowling WLG

Patrick Duxbury
  • Gowling WLG

Michael Herman
  • Gowling WLG