Fda Roundup (Briefs‪)‬

FDA ROUNDUP: Biolase Technology Inc. (Irvine CA) won approval for its dental laser, sending its shares up as much 10% on the week to $2.11. The medical device maker said the hand-held laser, about the size of a large pen, is approved for use by dentists and hygienists performing a full-range of minimally invasive soft-tissue and hygiene procedures. The company expects to begin shipping the product in April. Elsewhere, BioSante Pharmaceuticals Inc. (Lincolnshire IL) received orphan-drug status for its potential pancreatic cancer treatment. The company said the designation applied to its GVAX Pancreas Vaccine, which is undergoing clinical trials with other anticancer agents for safety, survival and response rates. The GVAX Pancreas Vaccine is a therapeutic vaccine that treats existing cancers. It does not prevent them. The FDA gives orphan drug status to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits. A product can be designated an orphan drug if it is meant to treat an illness than affects fewer than 200,000 people.