Posts tagged “BDSI”
BioDelivery Sciences plans to file a new drug application for its opioid dependence treatment BEMA Buprenorphine in the first half of 2013.
Over Onsolis' two-year shelf life, the product's pink appearance can fade. The FDA told the Raleigh company that the color change could confuse patients and the agency is directing BDSI to make formulation changes.
The U.S. Patent and Trademark Office has rejected all claims made by MonoSol Rx in the third MonoSol patent that the New Jersey company alleged BDSI had infringed. In total, MonoSol had made 222 claims covering three of its patents.
Triangle news: Bandwidth.com; BioDelivery Sciences; SAS; Precision BioSciences; Novella Clinical; SlickEdit
Bandwidth.com division Inetwork expands management team; BDSI says it prevails in patent fight; SAS makes knowledge management firm list; Precision files patent suit; Noval Clinical division adds new exec; SlickEdit to tout software to gamers.
Specialty pharmaceutical company BDSI says the USPTO has rejected all of the claims asserted by rival MonoSol in the latest patent claim. Both companies have technologies that deliver drugs via a small piece of film that dissolves in the mouth.
The Raleigh-based company receives an upfront payment of $30 million from Endo Pharmaceuticals for rights to its treatment technology for chronic pain.
Some opioid painkillers used by cancer patients are governed by U.S. Food and Drug Administration plans to manage possible health risks. The FDA is changing how it manages these drugs and these changes should help BDSI.
"We believe we are on course to become one of the first products to compete with Suboxone, a product with sales in excess of a billion dollars annually and currently without competition," CEO Mark Sirgo says.