FDA Gives Nod to Unigene Laboratories, Inc. (UGNE.OB) for Improved Drug Manufacturing Process
The US Food and Drug Administration (FDA) today gave Unigene Laboratories, Inc. (OTCBB:UGNE) the green light for one of two proposed improvements to the manufacturing process of its hallmark osteoporosis drug, Fortical. Specifically, Unigene received the go-ahead to modify a key enzyme in its patented manufacturing process for calcitonin, an active ingredient in the nasal spray. The FDA is reviewing another production modification that could boost batch yields of the drug by a factor of three, according to the company. “In addition to reducing our manufacturing costs, these improvements should enable us to more easily increase our capacity if Fortical…