July 13, 2009
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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:
- 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
- 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.
March 13, 2009
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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.
- Michael Taylor’s lab at SickKids discovered a family of eight genes that are mutated in patients with the most common childhood brain cancer. The research is published in Nature Genetics.
- Hans Knecht at Université de Sherbrooke, Sabine Mai at the University of Manitoba and colleagues published a paper in Leukemia identifying cytological changes associated with the transition from mononuclear Hodgkin cells (H cells) to diagnostic multinuclear Reed–Sternberg cells (RS cells), a critical step in the development of Hodgkin’s lymphoma.
- A group out of British Columbia published a study supporting the use of Resonant Medical’s Clarity system for the effective planning and treatment of breast cancer. Resonant Medical (Montreal, Canada) develops, manufactures and commercializes 3D ultrasound image-guided adaptive radiotherapy products.
- The Canadian Partnership Against Cancer study, a 30-year cancer study involving 300,000 Canadians, was announced nationally last summer, and is now underway in Atlantic Canada. Dr. Louise Parker of Dalhousie University and the Izaak Walton Killam Health Centre is the principal investigator in the Atlantic region for the $42-million project. The study will gather massive amounts of information about what patients eat, exercise, their body shapes, weight, etc.
- According to a study in Lancet Oncology by the European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups and the National Cancer Institute of Canada Clinical Trials Group, nearly 10 percent of brain cancer patients who received radiation in combination with chemotherapy were still alive five years after diagnosis, the best long-term survival rate ever reported for a group of patients stricken with the aggressive tumor. This treatment parallels the approach used by cancer specialists to treat Senator Edward M. Kennedy (D-MA), who was diagnosed in May with a malignant brain tumor.