Tag: first
First-Ever Electronic Medical Records and Advanced Imaging Technology Being Brought to 2012 London Olympics
For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs. GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance. The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping. We first saw the popularity of this drug grow among Tour de France cyclists.
Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics. GlaxoSmithKline will be the official lab services provider for the 2012 Olympic and … Read More »
Drug and Device Development Outsourcing
As companies outsource drug and device development overseas, reducing development time and research and development costs, additional legal concerns are raised. Last month a Shanghai court sentenced a researcher, employed by a leading Chinese pharmaceutical research firm, with 18 months’ probation, and ordered the employee to pay restitution for stealing and selling two patented compounds, owned by Merck.
The compounds were developed at the research firm, on behalf of Merck. Apparently the employee gained access to the compounds and sold them illegally. This case raises two important issues for manufacturers who outsource. First, can the outsourcing agreements with research firms adequately protect intellectual property rights and data from this type of misappropriation? Secondly, do patent portfolio strategies need to take into consideration these types of risks? To learn more about the case see the article attached….
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World’s First Stem-Cell Drug Approval Achieved in Canada
On May 17, 2012, Osiris Therapeutics announced that Canadian health regulators approved Prochymal, its drug for acute graft-versus host disease in children who have failed to respond to steroid treatment. Prochymal is the first stem cell drug to be approved anywhere in the world for a systemic disease. Graft-versus-host disease, a potentially fatal complication from bone marrow transplant, involves the newly implanted cells attacking the patient’s body. Until now, there have been no approved treatments for the disease. Prochymal is designed to control inflammation and promote tissue regeneration. Since the drug is made up of bone marrow stem cells derived from an adult donor, it circumvents ethical concerns that are raised by the use of stem cells derived from embryos. The Canadian approval is contingent on Osiris conducting further post-market testing—and it’s anticipated that if the FDA approves the drug when … Read More »