Posts tagged “BDSI”
BioDelivery Sciences International's opioid dependence treatment Bunavail faces an FDA decision date of June 7 and the Raleigh company is getting ready to go to market if it secures regulatory approval.
BioDelivery Sciences invested a mix of stock and cash that could total nearly $40 million if a proposed gel to treat diabetic neuropathy pain wins FDA approval, and the company says it will proceed with further tests after a "positive" meeting with regulators.
The Raleigh-based drug delivery technology firm projects sales of up to $250 million if the opioid dependence treatment wins FDA approval next year.
BioDelivery Sciences International's current pipeline reflects a shift in direction and a effort to stretch beyond the drug-delivery technology that was the initial focus for the company. Learn more about BDSI's strategy.
BioDelivery Sciences strikes a deal to license a potential treatment for diabetic neuropathy with privately held Arcion Therapeutics. The mix of stock and cash could total nearly $40 million if the drug wins approval.
Institutional investors have agreed to buy nearly 6.8 million of BDSI common shares and 2.7 million of newley designated Series A convertible preferred stock for an aggregate price of $4.21 each.
Inside the Bulldog Blog: SciQuest picks five charitable grant winners; Lenovo names winners in film contest; Quintiles lands deal in Mexico; BDSI reports good news on drug; Gentris expands headquarters.
The Raleigh-based firm also terminates its vice president for business and strategic development "without cause."
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.