BioDelivery Sciences International submits BUNAVAIL NDA to FDA BioDelivery Sciences International, Inc 60 mg per day . announced today that it involved in a positive pre-New Medication Application ending up in the U.S. Meals and Medication Administration concerning BUNAVAIL for the maintenance treatment of opioid dependence. This scheduled ending up in FDA relating to the NDA submission of BUNAVAIL was undertaken to examine the key data components for the NDA, which include data from a positive pivotal bioequivalence research versus Suboxone, an open-label safety research in individuals switched from Suboxone film or tablets to BUNAVAIL, and product stability info.S.

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announced today that the Investigational New Medication program for BMN-111, an analog of C-type Natriuretic Peptide , for achondroplasia is active. ‘BMN-111 provides demonstrated benefits in moderately and severely affected pet versions and has been proven to market bone growth also in normal pets,’ mentioned Hank Fuchs, M.D.’ The principal objective of the Stage 1 trial can be to assess the protection and tolerability of one and multiple dosages of BMN-111 in normal adult healthful volunteers up to the utmost tolerated dose.. BioMarin to initiate BMN-111 Stage 1 trial in achondroplasia BioMarin Pharmaceutical Inc.