Genentech Inc., of South San Francisco, a unit of the Roche Group, said the FDA accepted its biologics license application and granted priority review for pertuzumab in combination with Herceptin (trastuzumab) and docetaxel chemotherapy in HER2-positive metastatic or locally recurrent, unresectable breast cancer patients who have not received previous treatment or whose disease has relapsed after adjuvant therapy...Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA granted priority review

Sucampo and Takeda will discuss priority review with the FDA as Amitiza could be the first orally administered drug approved in the U.S

ThromboGenics NV, of Leuven, Belgium, said the FDA agreed to grant priority review to its biological license application (BLA) for ocriplasmin, a truncated form of the serine protease plasmin, in symptomatic vitreomacular adhesion

Chelsea submitted the NDA and requested priority review on Sept

The agency, however, denied the firm's request for priority review

Vismodegib, a Hedgehog inhibitor, also is under priority review in the U.S

Vismodegib, a Hedgehog inhibitor, also is under priority review in the U.S

The FDA accepted a new drug application from Vertex Pharmaceuticals Inc., of Cambridge, Mass., for Kalydeco (ivacaftor), in cystic fibrosis, also granting a request for six-month priority review

The agency assigned the anticoagulant priority review, setting a PDUFA date of March 28, 2012

The agency also granted priority review, setting a PDUFA date of March 28, 2012

The application was granted priority review status, with a PDUFA date of March 8, 2012

Health Canada awarded Optimer Pharmaceuticals Inc., of San Diego, priority review of its new drug submission for Dificid (fidaxomicin) tablets for Clostridium difficile infection

The FDA advised Titan on the requirements for priority review of the subcutaneous implant designed to deliver a six-month, round-the-clock dose as a treatment for opioid dependence

The company has orphan drug and fast-track status for HIV-PN and requested priority review

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA extended its target date to complete the priority review of a biologics license application for Eylea (aflibercept injection) in wet age-related macular degeneration by three months to Nov. 18, 2011

Incyte Corp., of Wilmington, Del., reported that the FDA has accepted for filing, with priority review, the new drug application for the company's lead compound, ruxolitinib, to treat myelofibrosis, a blood cancer with no FDA-approved treatments

Remicade previously received orphan drug status for pediatric use, and the biologics license application has received priority review

The company had hoped for priority review with the potential of launching late this year

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said the FDA granted its request for priority review of a supplemental biologics license application for Soliris (eculizumab) in atypical hemolytic uremic syndrome (aHUS