The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Senator Kennedy

Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

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Friday Science Review: March 13, 2009

Training Brains:  Sheena Josselyn’s lab at SickKids specifically erased a fear memory in mice by selectively ablating CREB neurons using an inducible diptheria toxin.  Let me break this down, because it’s so unbelievably cool: 

  • they trained mice to be afraid of a sound,
  • then they destroyed some specific cells in the brains of the mice,
  • then the mice forgot that they were afraid of the sound.

The mice were subsequently able to learn new things, like how to find cheese in a maze, and were even able to learn to be afraid of the same sound again.  Between this and the mind-reading experiment in the UK this week, it’s enough to give you a serious bout of insomnia … which often lasts over a year, according to researchers at Laval.

Gout Rout: Dr. Hyon Choi and colleagues at the University of British Columbia reported in Monday’s issue of the Archives of Internal Medicine, that Vitamin C appeared to lower the levels of uric acid in the blood, and that men who take in more vitamin C appear to be less likely to develop gout, a painful type of arthritis.

Beef Relief: Researchers using Bioniche’s E. coli O157 vaccine, Econiche™, published a study in Foodborne Pathogens and Disease showing that vaccinated cattle were 92% less likely to be colonized with E. coli O157:H7 than non-vaccinated cattle (odds ratio (OR)=0.07, p=0.0008). This is the second published study demonstrating more than 90% effectiveness of the Bioniche vaccine against colonization.

Anti-cancer Advancers:

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