The FDA sent Actelion a complete-response letter recommending additional risk analysis on Tracleer for a less severe form of pulmonary arterial hypertension. The drug is already approved in the U.S. to treat the rare heart and lung condition.
Scientists yesterday revealed the first map of common human genetic variations. Created by Perlegen Sciences, the map is a useful start toward customized gene-based medicine because identifying the tiny bits of genetic information called SNPs, or "snips," is key to moving forward, according to the study published in Science and presented to the American Association for the Advancement of Science.
The first human trial of the treatment, which involves injecting treated white blood cells directly into the patient's spinal cord, helped three of five subjects regain muscle movement, according to company officials. Proneuron plans to begin human trials this year of another therapy for brain injuries, using antigens to spur the immune system to send healing T cells to the brain.
If an FDA advisory panel decides today that all Cox-2 inhibitor drugs cause heart and stroke problems, and the agency agrees, then Merck will consider returning Vioxx to the market, its head of research testified. Merck's Dr. Peter Kim told the panel his drug has "unique benefits," and the company said in a statement later that if the FDA determines benefits outweigh the risks of Cox-2s, "we would have to consider the implications of these new data given the unique benefits Vioxx offers."
Monsanto announced the purchase of Emergent Genetics, the nation's third-largest cotton seed company, for $300 million. The purchase follows Monsanto's $1 billion purchase last month of Seminis, a supplier of seeds to growers in more than 150 countries.