Tag Archives: orphan drug regulation

FDA grants TGR1202 orphan drug designation for Chronic Lymphocytic Leukemia

T.G therapeutics, a bio pharmaceutical company based on developing drugs and effective treatments for B-cell malignancies and autoimmune diseases, declares it’s oral, next generation PI3K Delta inhibitor, TGR 1202,  as an orphan drug, approved by Food and Drug Association (FDA) for the treatment of patients with Chronic Lymphocytic Leukemia (CLL).  Presently, TGR 1202 is being examined for UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL.

Chronic lymphocytic leukemia is a kind of cancer caused by formation of a number of lymphocytes by bone marrow. CLL has been recorded to affect mostly adults, during or after their middle age. Approximately 20,000 people are diagnosed with CLL United States every year.


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FDA approves N-Methanocarbathymidine as orphan drug in U.S

N&N Pharmaceuticals Inc., an upcoming pharmaceuticals company announces N -Methanocarbathymidine receives orphan drug designation for the treatment of neonatal herpes simplex, by FDA.

Almost 25 % of all the pregnant women are seropositive for HSV-2, therefore, 85% of the neonates which are born with HSV-2 infection have one year mortality even with aggressive treatment. Despite of proper treatments the disease may cause death due to presence of virus-associated encephalitis and neutropenia.

Rare diseases are also known as Orphan diseases. These diseases are generally categorized as chronic, degenerative, and life-threatening. The rare diseases normally include certain cancers, metabolic conditions, diseases of the nervous system and musculoskeletal disorders, which are extremely life-threatening. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. These two regions form a dominant portion of the global market for orphan drugs.

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Or Visit:  Global Orphan Drug Market Future Outlook 2020