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FarmaKology Newsletter - Issue #24
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system.CEL-SCI's lead investigational therapy, Multikine®* (Leukocyte Interleukin, Injection), is currently being developed as a potential therapeutic agent aimed at harnessing the patient's own immune system to produce an anti-tumor response. Multikine is the trademark we have registered for this investigational therapy, and this proprietary name is subject to review by the U.S. Food and Drug Administration, or FDA, in connection with our future anticipated regulatory submission for approval.
Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years
Cassiopea SpA, a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action to address long-standing and essential dermatological conditions, announced today the U.S. Food and Drug Administration has accepted for review the New Drug Application for clascoterone cream 1%. Cassiopea is seeking marketing approval for clascoterone cream 1% for the treatment of acne.
Tokyo-based Daiichi Sankyo Company announced that its ESAX-DN Phase III trial of esaxerenone met the primary endpoint in diabetic nephropathy. The company presented the results in a late-breaking presentation at the annual meeting of the American Society of Nephrology held in Washington, DC. Daiichi Sankyo partnered with Alameda, California-based Exelixis on the drug.
The FDA approved luspatercept-aamt (Reblozyl) to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.Moreover, luspatercept is the first and only FDA-approved erythroid maturation agent.
A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare for satralizumab , an anti-interleukin-6 receptor humanized recycling antibody, for the treatment of neuromyelitis optica spectrum disorder .