Cleveland BioLabs, Inc. announced that the first healthy volunteers have been dosed in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS). CBLB502 is being developed by Cleveland BioLabs under the FDA’s Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident.

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Cleveland BioLabs, Inc. announced that the U.S. Patent and Trademark Office has issued US Patent No. 7,638,485 titled “Modulating Apoptosis” covering the method of protecting a mammal from radiation using flagellin or its derivatives, including CBLB502. This patent was already granted by the nine member countries of the Eurasian Patent Organization (EAPO), and two additional nations. Cleveland BioLabs has also filed two additional new patent applications related to Protectan technology in the U.S.

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Covidien Ltd. has received tentative FDA approval for the Abbreviated New Drug Application (ANDA) for its generic version of Cardiolite. The product, a Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, is a myocardial perfusion imaging-agent that is designed for detecting coronary artery disease. The product would receive final approval once Cardiolite’s marketing exclusivity period expires on July 29.