Puma Biotechnology Inc. (PBYI) said it will delay filing for U.S. regulatory approval of its experimental breast cancer treatment by as much as a year. The company’s shares fell 15 percent to $192.36 at 9:36 a.m. in New York, the most since June. The drugmaker announced yesterday that it would apply for Food and Drug [...]
http://www.forbes.com/sites/johnlamattina/2014/12/02/the-debate-over-the-cost-to-develop-a-new-drug/?partner=yahootix
http://www.forbes.com/sites/johnlamattina/2014/12/01/should-the-fda-force-drug-makers-to-discuss-their-clinical-trials/ Companies are not required to meet with the FDA to discuss their trial design. Nor are they required to follow their recommendations. As revealed in a recent research letter to the Journal of the American Medical Association (JAMA) ), of the 35 drugs approved from February 1, 2011 to February 29, 2012, companies met [...]
