FDA approves GSK’s nonadjuvant H1N1 vaccine
PHILADELPHIA GlaxoSmithKline on Tuesday announced that the Food and Drug Administration has approved its unadjuvanted influenza A(H1N1) pandemic vaccine.
The U.S. Department of Health and Human Services has placed an order to fill 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK, which will contribute to the approximately 250 million doses secured by the U.S. government. The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK’s facility in Quebec, Canada. GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.
An adjuvant is a substance added to a vaccine to improve the immune response, however none of the H1N1 vaccines currently approved in the U.S. contain adjuvants.
Teva files suit against Sandoz, Momenta over patent infringement
JERUSALEM Teva Pharmaceutical Industries has motioned to amend a complaint against two generic drug makers over their alleged infringement of Teva’s patent on a multiple sclerosis drug.
The Israeli drug maker announced Tuesday that it had sought to amend a complaint filed against Sandoz and Momenta Pharmaceuticals in the U.S. District Court for the Southern District of New York over their attempts to make a generic version of the injected drug Copaxone (glatiramer acetate). The amended complaint has been filed with the court under seal.
Teva, which makes branded drugs in addition to being the world’s largest manufacturer of generic drugs, originally filed the suit in August 2008, alleging infringement of multiple patents covering the drug.
Teva said that Copaxone is a “highly complicated” drug to develop, and given its inability to fully characterize its active ingredients, it has “serious doubts” about another drug company’s ability to make a comparable generic version.
Boston Scientific sponsors World Diabetes Day 2009
NATICK, Mass. A worldwide developer, manufacturer and marketer of medical devices announced its official sponsorship of World Diabetes Day for the second consecutive year. The program is organized by the International Diabetes Federation, and represents its primary global awareness campaign in the fight against diabetes.
The IDF is a worldwide alliance of more than 200 diabetes associations in 160 countries that share a mission of enhancing the lives of people with diabetes. It promotes appropriate diabetes care, prevention and the pursuit of a cure through such activities as World Diabetes Day, which will be observed Nov. 14.
“As a global leader in the medical device industry and a company committed to improving lives, we have a responsibility to support critical health initiatives like World Diabetes Day,” said David McFaul, Boston Scientific SVP international. “Many of our employees see first hand the devastating impact diabetes can have on patients and their families. We’re proud to continue our support of this important campaign with numerous activities planned at Boston Scientific sites around the globe intended to promote diabetes awareness and education.”
As part of its support, Boston Scientific once again will participate in the IDF World Diabetes Day Monument Challenge by temporarily illuminating its corporate headquarters in Natick, Mass., and changing the color of its Internet homepage to blue in recognition of World Diabetes Day on Nov. 14. Additionally, Boston Scientific further will support World Diabetes Day with activities at company facilities around the world, including free diabetes screenings for employees and “lunch and learn” sessions.