BDSI prices $15 million private placement
BioDelivery Sciences International, Inc. announces that it has received definitive commitments from institutional investors for a private placement financing yielding gross proceeds of $15 million to...
View ArticleBDSI's BEMA drug delivery technology receives Canada patent
BioDelivery Sciences International, Inc. announced the issuance of a patent extending the exclusivity of the BioErodible MucoAdhesive drug delivery technology in Canada from 2017 to 2027. The patent...
View ArticleBDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain
BioDelivery Sciences International, Inc. announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine...
View ArticlePositive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1...
BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.
View ArticleSingle shared REMS for TIRF products receives FDA approval
The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared...
View ArticleEndo, BDSI partner to develop and commercialize BEMA Buprenorphine for...
BioDelivery Sciences International, Inc. today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize...
View ArticleUSPTO rejects MonoSol's patent infringement claims against BDSI
The United States Patent & Trademark Office has informed BioDelivery Sciences International, Inc. that it has rejected all claims by MonoSol Rx, LLC (MonoSol) in its US Patent No. 7,425,292 (the...
View ArticleBDSI announces postponement of ONSOLIS U.S. relaunch
BioDelivery Sciences International, Inc. today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two...
View ArticleEnrollment complete in BDSI's pivotal pharmacokinetic study of BNX for opioid...
BioDelivery Sciences International, Inc. announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid...
View ArticleBioDelivery Sciences International submits BUNAVAIL NDA to FDA
BioDelivery Sciences International, Inc. announced today that it engaged in a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding BUNAVAIL for the maintenance...
View ArticleBiodelivery Sciences collaborates with Quintiles to launch BUNAVAIL in the U.S.
BioDelivery Sciences International, Inc. announced that it has entered into an agreement with Quintiles to provide a range of services to support the anticipated launch of BUNAVAIL (buprenorphine and...
View ArticleBDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for...
BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful...
View ArticleMeda reaches agreement with Valeant to terminate joint ventures
Meda has reached an agreement with Valeant to terminate the companies' joint ventures in Canada, Mexico and Australia in the second quarter of 2014. In all three countries own Meda affiliates have been...
View ArticleBioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA
BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAILâ„¢ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).
View ArticleBioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN...
BioDelivery Sciences International, Inc. announced today that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment...
View ArticleBDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl...
BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal...
View ArticleUSPTO rejects MonoSol's patent infringement claims against BDSI
The United States Patent & Trademark Office has informed BioDelivery Sciences International, Inc. that it has rejected all claims by MonoSol Rx, LLC (MonoSol) in its US Patent No. 7,425,292 (the...
View ArticleBDSI announces postponement of ONSOLIS U.S. relaunch
BioDelivery Sciences International, Inc. today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two...
View ArticleEnrollment complete in BDSI's pivotal pharmacokinetic study of BNX for opioid...
BioDelivery Sciences International, Inc. announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid...
View ArticleBioDelivery Sciences International submits BUNAVAIL NDA to FDA
BioDelivery Sciences International, Inc. announced today that it engaged in a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding BUNAVAIL for the maintenance...
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