Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, specializing in the treatment of hard to treat and antibiotic-resistant infections, announced that the U.S. FDA has granted MBN-101 Fast Track designation for adjunctive treatment of mild and moderate diabetic foot ulcer infections.
Dynavax Technologies Corporation announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.