• FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP

    Advisory Committees for the US Food and Drug Administration (FDA) cleared two high-profile pharmaceutical products on 10 May that would, respectively, help patients to lose weight and prevent patients from contracting the Human Immunodeficiency Virus. Arena Pharmaceuticals' Lorcaserin: The New York Times : "Government advisers recommended approval on Thursday of a weight-loss drug developed by Arena Pharmaceuticals, making it likely that a new obesity trea...
  • BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...