NetworkNewsBreaks – AzurRx BioPharma, Inc. (NASDAQ: AZRX) and Mayoly Spindler Submit IMPD in Europe for Lead Product, MS1819-SD
AzurRx BioPharma (NASDAQ: AZRX) this morning said it has submitted an Investigational Medicinal Product Dossier (IMPD) for MS1819-SD. The company’s lead product, currently under development as part of a join research and development agreement with Laboratoires Mayoly Spindler, SAS, is a recombinant lipase for the treatment of exocrine pancreatic insufficiency caused by chronic pancreatitis and cystic fibrosis. Prior to opening clinical centers in France as part of the company’s ongoing clinical study, the IMPD was submitted for approval through the European Medicines Agency clinical trial portal. Among other information, the IMPD includes data from clinical and non-clinical studies, and information…







