Novartis Pharmaceuticals Corp., a division of Novartis AG, of Basel, Switzerland, said it has been awarded the first priority review voucher issued under the Food and Drug Administration Amendments Act of 2007 in conjunction with the FDA's approval of the antimalarial drug Coartem (artemether-lumefantrine...The voucher awarded to Novartis entitles the company to receive a priority review for a future new drug application, potentially shortening the FDA review process to six months from the typical

Genmab A/S, of Copenhagen, Denmark, said the FDA accepted for filing and granted priority review for a biologics license application for CD20 antibody Arzerra (ofatumumab) in patients whose chronic lymphocytic leukemia is resistant to previous therapies...Priority review sets the target date for a decision at six months after submission

Genmab A/S, of Copenhagen, Denmark, said the FDA accepted for filing and granted priority review for a biologics license application for CD20 antibody Arzerra (ofatumumab) in patients whose chronic lymphocytic leukemia is resistant to previous therapies...Priority review sets the target date for a decision at six months after submission

Fast-track drugs ordinarily qualify for priority review, and it allows the SGN-35 new drug application to be considered for submission on a rolling basis

The company submitted its application Dec. 30 and had been aiming for - but did not receive - priority review. (See BioWorld Today, Dec. 31, 2008

The agency granted priority review for Acurox and has set June 30 as the Prescription Drug User Fee Act action date

Cell Therapeutics Inc., of Seattle, said that it CTI expects to begin submission of a rolling new drug application (NDA) and request priority review in the current quarter for pixantrone to treat relapsed aggressive non-Hodgkin's lymphoma...If granted priority review, a decision on the NDA could occur before the end of the year

Dyax submitted its BLA in September based on data from two Phase III studies, and the application was designated for priority review

Cell Therapeutics Inc., of Seattle, said that the FDA has granted priority review status for the supplemental biologics license application for use of Zevalin ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy

Protherics said it intends to seek a priority review, leading to a potential marketing approval in the U.S

If the FDA grants the NDA priority review, Clolar could be approved in that indication in the first half of 2009

Dyax Corp., of Cambridge, Mass., said the FDA accepted for filing its biologics license application for DX-88 (ecallantide) in acute attacks of hereditary angioedema and has designated the application for priority review, giving it a PDUFA date of March 23, 2009

The application has been granted priority-review status, the firms said...Savient Pharmaceuticals Inc., East Brunswick, N.J., said it submitted its biologics license application to the FDA for its gout drug pegloticase, which has been granted orphan drug status, along with a request for priority review

Northfield also requested priority review, based on the potential for PolyHeme to address a critical, unmet medical need

The FDA also indicated that Neuropharm is eligible to apply for priority review when the submission is complete

The company requested priority review

Genzyme also announced that its new drug application for Mozobil (plerixafor) has been granted priority review and an action date of Dec.16

Cell Therapeutics anticipates filing the application in the fourth quarter and requesting priority review

GTC Biotherapeutics Inc., of Framingham, Mass., said the FDA assigned priority review to its biologics license application for ATryn (recombinant human antithrombin) in the treatment of patients with hereditary antithrombin deficiency at risk of deep vein thrombosis and other thromboembolisms following surgery