07:00 , Aug 5, 2013 |  BC Week In Review  |  Clinical News

Painkyl regulatory update

BioDelivery said that Taiwan approved Painkyl fentanyl to manage breakthrough cancer pain in opioid-tolerant adult patients with cancer. The approval triggers a $300,000 milestone payment to BioDelivery from TTY, which has exclusive rights to develop...
07:00 , May 20, 2013 |  BC Week In Review  |  Clinical News

Onsolis regulatory update

BioDelivery disclosed in its 1Q13 earnings that it and Meda submitted a proposal to FDA in March to relaunch pain drug Onsolis fentanyl in the U.S., with a potential launch slated for next half. Last...
07:00 , Oct 29, 2012 |  BC Week In Review  |  Company News

Alvogen, KunWha Pharmaceutical deal

Alvogen acquired a majority stake in fellow generics company Kunwha through a combination of newly issued Kunwha shares and the acquisition of shares from individual Kunwha shareholders, including Chairman Hongsun Chang. The companies said the...
08:00 , Jan 2, 2012 |  BC Week In Review  |  Clinical News

Abstral fentanyl regulatory update

FDA approved a single REMS for the class of transmucosal immediate-release fentanyl pain drugs to reduce the risk of misuse, abuse, addiction and overdose. The shared REMS, which takes effect in March, will replace separate...
08:00 , Nov 14, 2011 |  BC Week In Review  |  Clinical News

Onsolis regulatory update

BioDelivery said partner TTY Biopharm submitted an NDA to the Taiwan Food and Drug Administration for BEMA Fentanyl to treat breakthrough pain in opioid-tolerant patients. The submission triggers a $300,000 milestone payment to BioDelivery from...
07:00 , Jun 13, 2011 |  BC Week In Review  |  Clinical News

Onsolis fentanyl buccal soluble film regulatory update

BioDelivery said it and partner Meda expect an FDA response on a modified REMS program for pain drug Onsolis fentanyl buccal soluble film will be delayed until this summer. BioDelivery previously anticipated the FDA review...
07:00 , Oct 25, 2010 |  BC Week In Review  |  Clinical News

Breakyl regulatory update

BioDelivery Sciences and Meda said an MAA for Breakyl BEMA fentanyl to manage breakthrough cancer pain in opioid-tolerant adults received approval via the European decentralized procedure, with Germany acting as the reference member state. The...
07:00 , Sep 6, 2010 |  BC Week In Review  |  Clinical News

Onsolis regulatory update

BioDelivery said it and partner Meda met with FDA to discuss amending the existing REMS program for Onsolis, an adhesive disc formulation of fentanyl marketed to manage breakthrough pain in cancer patients already receiving and...
07:00 , Jun 7, 2010 |  BC Week In Review  |  Company News

BioDelivery, KunWha Pharmaceutical sales and marketing update

BioDelivery granted KunWha exclusive rights to develop and commercialize BEMA fentanyl ( Onsolis ) in South Korea. The adhesive disc formulation of fentanyl is approved in the U.S. and Canada and under review in the...