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http://www.marketwatch.com/story/bio...llaytm-product

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Savient announce advisory committee recommends FDA approval for KRYSTEXXA
Savient Pharmaceuticals announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration recommended by a vote of 14 to 1 that KRYSTEXXA, a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout. Refractory chronic gout or treatment failure gout is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee action date for the FDA's decision as to whether to grant marketing approval for KRYSTEXXA is August 1.

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SVA is up 14% at the moment because of news.


Sinovac Claims Bragging Rights as First Vaccine Maker to Complete Swine Flu Test -- Seeking Alpha

Sinovac Claims Bragging Rights as First Vaccine Maker to Complete Swine Flu Test
August 18, 2009

Sinovac Biotech Ltd. (SVA) reported that its swine flu (H1N1) vaccine was effective after a single dose. The seropositive rate, seroconvertive rate and GMT increasing multiple have reached the international criteria for vaccines, which indicates that Sinovac's H1N1 vaccine has good immunogenicity and offers protection.

The top-line results were unblinded in Beijing Monday afternoon. The event allows Sinovac to claim bragging rights as the first vaccine manufacturer in the world to complete a test of a swine flu vaccine.

No severe adverse reactions were reported. The only negative reactions were mild, most commonly pain at the injection site, which was experienced at about the same rate as seen with any flu vaccine.

In the trial, 1,614 participants over the age of 3 were inoculated. Blood samples were collected on the vaccination date, and then 14 and 21 days post vaccination date. The National Institute for the Control of Pharmaceutical and Biological Products (NICBPB), the central laboratory of the SFDA, completed the HI antibody tests on all blood samples.

Earlier, Sinovac said the trial would involve two inoculations and that it would have vaccine ready for sale in late September, after the trial was concluded and SFDA approval granted. With a single inoculation, the schedule may be moved forward.

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is finally moving, because it has received not FDA approval yet, but approval for investigational treatment for oralyn...
CORRECTED - CORRECTED-BRIEF-Generex drug approved for investigational treatm | Markets | Markets News | Reuters