All Blog Posts Tagged 'Orphan' (6)

FDA Approves Orphan Drug Erwinaze™ for Treatment of Acute Lymphoblastic Leukemia for patients with hypersensitivity to standard-of-care treatment

The U.S. Food and Drug Administration (FDA) has approved its orphan drug asparaginase Erwinia chrysanthemi (Erwinaze™ www.erwinaze.com , EUSA Pharma) for the treatment of acute lymphoblastic leukemia (ALL) in patients who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL. The new drug will…

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Added by Peter Hofland, PhD on November 18, 2011 at 6:30pm — No Comments

FDA Grants Orphan Status for Investigational Drugs for Soft Tissus Sarcoma and Pancreatic Cancer

The United States Food and Drug Administration (FDA) has granted orphan drug designations to two investigational cancer drugs under devlopment by Morphotek®, Inc., a subsidiary of Eisai Inc. The drugs are MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer.



The FDA grants this designation to drugs with… Continue

Added by Peter Hofland, PhD on June 8, 2011 at 6:30am — No Comments

Regorafenib (BAY 73-4506) Received Orphan Drug Status for the Treatment of Gastrointestinal Stromal Tumors

The U.S. Food and Drug Administration (FDA) has granted orphan drug status for the investigational compound regorafenib (BAY 73-4506). The new compound will be used for the treatment of patients with gastrointestinal stromal tumors (GIST) and is under developed by Bayer HealthCare Pharmaceuticals Inc.



GIST is the most common form of sarcoma involving the gastrointestinal tract. GISTs arise in the GI tract,…

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Added by Peter Hofland, PhD on February 4, 2011 at 1:00am — No Comments

Orphan Drug Designation for FAK Inhibitor in Treatment of Pancreatic Cancer

Focal Adhesion Kinase (FAK), a member of a family of nonreceptor protein-tyrosine kinases, is substantially over-expressed in many cancers, including breast, thyroid, prostate, colon, cervical, ovarian, liver and pancreatic cancer [1, 2]. FAK operates by placing itself at the contact points between tumor cells and the extra cellular matrix that surrounds them.



Researchers have found that FAK is an important facilitator for signals that cause tumor cells to…

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Added by Peter Hofland, PhD on January 18, 2011 at 3:30pm — No Comments

FDA Grants New Recombinant Anti-CD20 Monoclonal Antibody Orphan Drug Status for CLL

The recombinant anti-CD20 monoclonal antibody (LFB-R603) produced by LFB Biotechnologies, a leading European biopharmaceutical company, received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.



Chronic lymphocytic leukemia is the most common form of leukemia in the United… Continue

Added by Peter Hofland, PhD on August 26, 2010 at 6:30am — No Comments

Europe Grants Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma

The European Medicines Agency (EMEA) has granted an orphan drug designation for pixantrone (BBR 2778, pixantrone dimaleate), an experimental topoisomerase II inhibitor with an aza-anthracenedione molecular structure, used for the treatment of Diffuse Large B-Cell Lymphoma… Continue

Added by Peter Hofland, PhD on December 21, 2009 at 7:30am — No Comments

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