Halfway into fiscal 2013, the FDA is finally looking at a budget that allows it to use the new and increased user fees that were approved as part of PDUFA V last year. Read More
Privately held gene therapy company bluebird bio soared to new heights in a discovery, development and commercialization deal with big biotech Celgene Corp. to use its technology to genetically modify a patient's own T cells to target and destroy cancer cells. The multiyear R&D collaboration has the potential to generate multiple products based on the modified cells, known as chimeric antigen receptor (CAR) T cells. Read More
Safety concerns were front and center at Thursday's meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) reviewing Titan Pharmaceuticals Inc.'s application for Probuphine, an implantable device delivering a steady dose of buprenorphine for up to six months for opioid dependence. Read More
Hepatitis C virus (HCV) player Enanta Pharmaceuticals Inc. priced a $56 million initial public offering (IPO) and received a warm welcome from Wall Street, as its newly listed shares shot up 22.7 percent on its first day of trading. Read More
• Medivir AB, of Huddinge, Sweden, said it will divide its R&D organization into two parts, Discovery Research and Development, and said the research organization will be led by Richard Bethell. Read More
• Bioheart Inc., of Sunrise, Fla., said it secured sufficient funding to begin the Phase I ANGEL safety and efficacy trial of LipiCell (adipose-derived stem cells) in congestive heart failure. Read More
• Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus. Read More
• BrainStorm Cell Therapeutics Inc., of New York, reported some of the final results from a clinical study evaluating its NurOwn technology in 12 amyotrophic lateral sclerosis (ALS) patients. Read More
• LEO Pharma UK, of Princes Risborough, UK, reported that data published in the Journal of the American Medical Association Dermatology demonstrated the long-term effectiveness of Picato (ingenol mebutate) in treating actinic keratosis (AK), a leading cause of nonmelanoma skin cancer. Read More
