Tag Archives: globla orphan drug market

Yisheng Biopharma’s Biological Product receives orphan drug status for Hepatocellular Carcinoma

Yisheng Biopharma Co. Ltd. Is a bio pharmaceutical company specialized in development, research, manufacture, marketing and sales of immunotherapeutic products and vaccines, declared that US Food and Drugs Association has granted orphan drug designation to its leading candidate, YS-ON-001 for the treatment of Hepatocellular Carcinoma. YS-ON-001 consist of immune-modulating effects like induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization, and suppression of regulatory T cells.

Previously, YS-ON-001 has acted as a promising agent with anti-tumor efficacy in the treatment of breast, lung, liver and other cancers as compared to the first-line chemotherapies or targeted therapies.

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. Orphan drug status is intended to facilitate drug development for rare diseases and provides several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

For Free Sample of Global Orphan Drug Clinical Pipeline Reports Contact: avinash@kuickresearch.com

Or Visit:  Global Orphan Drug Market Future Outlook 2020

 

Tivorsan receives orphan drug designation for Human Recombinant Biglycan for DMD

Tivorsan pharmaceutical, a company focusing on developing drugs and treatments for all kinds of Duchenne Muscular Dystrophy (DMD) and other neuromuscular disorders, declared that food and Drug Association (FDA) has granted Orphan drug designation to its leading drug candidate, Human Recombinant Biglycan for the treatment of DMD.

Human Recombinant Biglycan, also called as TVN-102, is a small, naturally occurring extracellular matrix protein found in muscle. It has a unique mechanism of action, that of up regulating utrophin, nNOS (neuronal nitric oxide synthase) and other dystrophin-associated proteins in the muscle membrane, as well as controlling MuSK (muscle specific kinase) activity and localization at the nerve-muscle synapse.

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. Orphan drug status is intended to facilitate drug development for rare diseases and provides several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

For Free Sample of Global Orphan Drug Clinical Pipeline Reports Contact: avinash@kuickresearch.com

Or Visit:  Global Orphan Drug Market Future Outlook 2020

 

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.

Original Headline- TG Therapeutics Announces Orphan Drug Designation for TGR-1202 for Treatment of Chronic Lymphocytic Leukemia

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.Orphan drug status is intended to facilitate drug development for rare diseases and provides several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

For Free Sample of Global Orphan Drug Clinical Pipeline Reports Contact: avinash@kuickresearch.com

Or Visit:  Global Orphan Drug Market Future Outlook 2020