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Kedrion Biopharma, and Kamada Ltd. (NASDAQ and TASE: KMDA) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BL) for a human anti-rabies immunoglobulin (IgG) therapy
Kamada announced today the extension of the strategic partnership with Shire plc (LSE: SHP, NASDAQ: SHPG) for GLASSIA® .
Minimum revenue for GLASSIA in the extended agreement for the years 2017 to 2020 will reach approximately $237 million and may be expanded to $288 million during that period.
Kamada and Kedrion, collaborators on development and commercialization of post-exposure treatment for suspected rabies, announced today the filing of a BLA with the FDA. On approval by FDA, the product will represent a new option in a market where supply of post-exposure rabies treatment has been inconsistent over time. Companies planning for decision from FDA in mid-2017
Company's inhaled AAT demonstrated significant increase in endothelial lining fluid inhibitory capacity. Study results also showed that inhaled aat is the most efficient way of delivering therapeutic amounts of AAT to the primary sites of potential lung injury. Kamada to utilize results to design pivotal U.S.. study and support responses to European Medicines Agency (EMA) regarding company's Marketing Authorization Application (MAA) for inhaled AAT.
Kamada management will host an investment community conference call on Tuesday, August 2, 2016 at 8:30 a.m. Eastern time to discuss these results and answer questions.
Kamada announced the appointment of Naveh Tov, M.D., Ph.D., to the position of Vice President, Clinical Development and Medical Director for Pulmonary Diseases, effective July 1, 2016.
GLASSIA [Alpha-1 Proteinase Inhibitor (Human)] is the only FDA approved alpha-1 antitrypsin (AAT) augmentation treatment that patients can self-infuse at home.
Announced a collaboration to provide early access throughout Europe to Kamada's proprietary, highly-purified, liquid form of Alpha-1 Antitrypsin (AAT) to treat bone marrow transplant patients who develop steroid refractory Graft-Versus-Host Disease (GvHD).