PHARMACY

GSK flu vaccine facility in Quebec is nearly completed

BY Allison Cerra

QUEBEC CITY, Canada GlaxoSmithKline said that it is near completion of its Quebec City manufacturing facility, used to develop the company’s influenza vaccine.

After a two-year—and $199 million—investment to upgrade the manufacturing site, the location will increase the capacity of vaccine doses to 75 million per year, the company said. The expansion has also given way to providing this facility, and existing ones, new equipment and other innovative technologies to assure efficient production.

The company has also doubled the size of its vaccine workforce in Quebec City since January 2006.

“[This] announcement reinforces the key role that both Quebec and Canada play in GSK’s global vaccine business,” said Michel Baijot, vice president of Worldwide Strategic Alliances and Business Development, GlaxoSmithKline Biologicals, the company’s vaccine division. “Through this investment, Quebec and Canada will have an impact on global health by supporting countries in their influenza pandemic planning.”

According to GSK, the company supplies about 75% of the Canadian government’s seasonal flu vaccine purchases and will also provide Canada with a pandemic vaccine in the event of an influenza pandemic. 

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Evista gets FDA approval for new use to reduce breast cancer risk

BY Drew Buono

INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.

The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.

The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.

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Cubist to ask for patent reissue for Cubicin

BY Drew Buono

LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.

Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016.  Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.

On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug.  Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.

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