Week of July 30, 2012: FDA Issues Complete Response Letter to Luitpold Pharmaceuticals for Injectafer NDA; Novasep Invests to Expand API Manufacturing Capabilities; and More

Cleveland BioLabs has signed a contract valued at 139 million Russian rubles ($4 million) with the Ministry of Industry and Trade of the Russian Federation for development of CBLB612, a drug in development for stimulation of hematopoietic stem-cell proliferation and mobilization. The contract provides funding over a period of approximately three years, which will be used to support completion of preclinical studies, filing of an investigational new drug application, and Phase I and II clinical studies. The contract was issued by Russia’s Pharma 2020 plan, a government initiative to stimulate pharmaceutical-based economic development. Read More

FDA has issued a Complete Response Letter to Luitpold Pharmaceuticals, part of Daiichi Sankyo, for the company’s Sept. 30, 2011, new drug application (NDA) for Injectafer (ferric carboxymaltose injection), for treating iron deficiency anemia. In the Complete Response Letter, FDA noted its decision to withhold approval at this time. The decision was not related to any issues with the Injectafer NDA filing, but with Luitpold’s manufacturing facility in Shirley, New York. During a recent inspection, FDA inspectors noted issues in the facility where Injectafer is manufactured for the US market. Luitpold Pharmaceuticals said it’s working with FDA to resolve the issues found in the recent inspection. Read More

Novasep has announced a EUR 3-million ($3.69 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The expansion is expected to be fully operational by the beginning of 2013. Read More