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Priority Review
Artemisinin-based Combination Treatment (ACT)
09-15-2008 |  12:28 hs.
Novartis AG announced that U.S. regulators have granted a priority review designation for their anti-malaria artemisinin-based combination treatment (ACT) Coartem, which would reduce reviewing time to six months. Coartem is already being used successfully in Africa, with 96 percent proven effectiveness. Further details.

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Advanced kidney cancer treatment
09-09-2008 |  10:25 hs.
Switzerland´s Novartis AG reported that its cancer drug candidate RAD001 (generically, everolimus) received priority review designation from the U.S. Food and Drug Administration (FDA). Novartis has completed successful trials with advanced kidney cancer patients as with other tumor growths, using this medication in a once-a-day pill dose. Further details.

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09-04-2008 |  11:22 hs.

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Novartis blockbuster for gastrointestinal tumors, leukemia
08-27-2008 |  11:07 hs.
Switzerland´s Novartis AG won an expedited review from U.S. health regulators for an application to sell the cancer drug Glivec/Gleevec for use after surgery to remove stomach and intestinal tumors. Review is lowered from 10 to 6 months. Further details.

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King Pharmaceuticals/Pain Therapeutics´ Remoxy
08-12-2008 |  12:20 hs.
The U.S. Food and Drug Administration (FDA) have granted priority status to an experimental abuse-resistant painkiller from King Pharmaceuticals Inc and Pain Therapeutics Inc, the companies announced - it should therefore be up for review before the end of 2008.

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Multaq
08-08-2008 |  10:38 hs.
Sanofi-Aventis´s experimental heart drug Multaq has been granted priority review by the U.S. Food and Drug Administration (FDA). Some analysts believe this product could reach $ 2 billion dollars in sales by 2015. Further details.

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Chronic ITP
03-03-2008 |  12:33 hs.
U.K.’s Glaxo has received Priority Review from the FDA for its Promacta (eltrombopag) for the short-term treatment of patients with ITP

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Eli Lilly and Daiichi Sankyo’s Experimental Blood Clot Drug
02-22-2008 |  12:59 hs.
Eli Lilly & Co. and Japan’s Daiichi Sankyo announced that the Food and Drug Administration (FDA) had granted priority review to their experimental blood clot drug Prasugrel filed with the U.S. health regulators in December 2007. On February 21st the two companies submitted a joint Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in London, seeking approval to market Prasugrel within the European Union. Full story.

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