Pharmacyclics Inc., with partner Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, became the latest in a small handful of companies to gain "breakthrough therapy designation," a new category that could let drug developers win approval of their drug candidates based on single, Phase I trials. Read More
Are risk evaluation and mitigation strategies (REMS) actually making any difference when it comes to drug safety? Enquiring minds at the Health and Human Services' Office of Inspector General (OIG) want to know. The trouble is the FDA doesn't have the data to answer the question. Read More
Researchers at the National Institute of Allergy and Infectious Diseases have discovered that by targeting a bacterial transporter Staphylococcus aureus uses to export its toxins, they were able to not only reduce S. aureus virulence, but to kill the bacterium outright. Read More
Stock in AVEO Pharmaceuticals Inc. softened following a clinical trial update released in conjunction with the company's full year 2012 earnings. Trial design may have confounded results for tivozanib, which show overall survival (OS) trends favoring the comparator drug Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG), with OS of 28.8 months for tivozanib and 29.3 months for sorafenib (p = 0. 105). Read More
San Diego-based Trius Therapeutics Inc. said the results from its first pivotal Phase III study of tedizolid phosphate (TR-701) vs. linezolid (Zyvox) completed in 2011 (ESTABLISH 1), have been published in the Journal of the American Medical Association (JAMA). Read More
• Algeta ASA, of Oslo, Norway, said that its partner Bayer AG, of Leverkusen, Germany, has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the FDA. Read More
• Dendreon Corp., of Bridgewater, N.J., reported findings from several ongoing or completed studies of Provenge (sipuleucel-T) in advanced prostate cancer ahead of the 2013 American Society of Clinical Oncology Genitourinary Cancers Symposium in Orlando, Fla. Read More
• Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., said the FDA granted approval of Pioglitazone Hydrochloride tablets, which is being manufactured and supplied by Synthon Pharmaceuticals Inc., and will be available in 15-mg, 30-mg, and 45-mg strengths. Read More
• Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said updated Phase III results showed Zytiga (abiraterone acetate) plus prednisone continued to provide statistically significant improvements in disease progression compared to placebo plus prednisone, and longer overall survival in men with metastatic castration-resistant prostate cancer. Read More
• Acorda Therapeutics Inc., of Ardsley, N.Y., beat analyst estimates with its net revenues hitting $81.5 million for the fourth quarter vs. the $79.8 million consensus. The company reported GAAP net income of $133 million for the quarter ended Dec. 31, 2012, or $3.27 per diluted EPS. Read More
