NASDAQ Stock Movers On FDA Decision (NVAX, SCR, VICL, CNI, DCTH)

Novavax, Inc. (Nasdaq: NVAX) announced today that the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), has determined the Company's proposal to provide recombinant influenza vaccineproducts and manufacturing capabilities for pandemic preparedness is in the competitive range for award of an advanced development contract.

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Simcere Pharmaceutical Group (NYSE: SCR) today announced that its diosmectite, the Active Pharmaceutical Ingredient (API) in Simcere's branded generic drug Biqi, has passed EU-GMP inspection. This enables Simcere to market diosmectite in the European Union countries.

Vical Incorporated (Nasdaq: VICL) announced today that the company's TransVax cytomegalovirus (CMV) vaccine elicited sustained increases in both cellular and antibody immune responses compared with placebo through the final 12-month follow-up in an ongoing Phase 2 trial in hematopoietic cell transplant (HCT) recipients.

The US Food and Drug Administration (FDA) has approved Zortress (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

Delcath Systems, Inc. (NASDAQ:DCTH) said a Phase III clinical trial on the device has met the primary endpoint in treating patients with inoperable liver cancer.

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