Shares of Avanir Pharmaceuticals Inc. nearly doubled as the company rapidly shifted into commercialization mode following FDA approval late Friday of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), the first and only FDA-approved treatment for pseudobulbar affect (PBA). (BioWorld Today)

After learning late last week that lead program teplizumab failed to meet its primary endpoint in a Phase III trial for Type 1 diabetes, MacroGenics Inc. President and CEO Scott Koenig was disappointed, but philosophical. (BioWorld Today)

Industrial-scale manufacturing of Cinryze (C1-esterase inhibitor, human) will stay on schedule despite an FDA complete response letter requesting additional information about the expansion, according to ViroPharma Inc.'s President and CEO Vincent Milano. (BioWorld Today)