The idea that there is a Chinese wall between the brain and the immune system has been eroding for some time now. (See BioWorld Today, Aug. 2, 2011, and Nov. 6, 2007.) Read More
Transcept Pharmaceuticals Inc. and Vivus Inc. each have adjusted the proposed labeling of their respective products in response to FDA concerns, with the hope that more restrictive labels will allow the products to be approved. Transcept's Intermezzo (zolpidem tartrate sublingual tablets) for insomnia will carry a lower recommended dose for women and instructions detailing the safest use of the drug. Likewise, Vivus is adding labeling material for Qnexa (phentermine/topiramate) stating that the drug is contraindicated for women with childbearing potential. Read More
Vaxin Inc., of Rockville, Md., received a $14.7 million contract over two years from the Biomedical Advanced Research and Development Authority for the development of a next-generation anthrax vaccine. The contract could be extended for a total of up to four years and $21.7 million. Read More
Phenex Pharmaceuticals AG, of Ludwigshafen, Germany, began a Phase I trial of its candidate for non-alcoholic steatohepatitis, Px-102. The study will escalate through seven dose levels, and the first dose tested has produced no discomforts or adverse effects. Read More
Uluru Inc., of Addison, Texas, said Ironridge Global BioPharma and its affiliates committed in two transactions to purchase common and preferred stock totaling up to $1.6 million. One of the transactions includes a purchase of up to $650,000 in convertible, redeemable, preferred stock with a 7.5 percent dividend. Read More
Soligenix Inc. (formerly DOR BioPharma Inc.) halted its confirmatory Phase III trial of orBec (oral beclomethasone dipropionate, or OBD) for acute gastrointestinal graft-vs.-host disease (GvHD) following stem cell transplant after an interim analysis by an independent data safety monitoring board concluded the study was "highly unlikely" to meet its predetermined efficacy endpoint. No safety concerns were raised. Read More
Recognizing the unmet needs of patients with specific types of prostate cancer, the FDA may be opening the door for new drugs and surrogate endpoints. Read More
