Tag Archives: orphand rug

FDA approves SD-809 for orphan drug designation

The US food and drug Administration (FDA) has granted orphan drug status SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The compound is being developed by an Israeli drug manufacturer, Teva Pharmaceutical Industries (NYSE: TEVA). The drug is also being tested for the treatment of tardive dyskinesia (TD) and Tourette syndrome (TS).

The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.

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

Or Visit:  Global Orphan Drug Market Future Outlook 2020

 

EC grants orphan drug designation to Philogen SpA for the treatment of soft tissue sarcoma.

Philogen SpA, a clinical stage biological company dedicated to develop and commercialize immunology and immune-oncology protein therapeutics, declared that European commission has granted orphan drug designation to L19TNF – a non-covalent trimer of tumor necrosis factor (TNF) fused to an antibody specific to the extra-domain B of fibronectin in single-chain variable fragment format – for the treatment of soft-tissue sarcoma. Soft tissue sarcoma is estimated to affect approximately 2.8 in every 10,000 people in Europe and possess 5year survival rate of 58% for patients suffering from STS.

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

 

Ovarian Cancer gets Orphan Drugs as ZW25 & ZW33; approves FDA

Zymeworks, a pharmaceutical company, announces that Food and Drug Association (FDA) has granted orphan drug designation to ZW25 and ZW33 for effective treatment of ovarian cancer.

ZW25 is a novel bispecific antibody designed to target two different epitopes of the HER-2 protein, overexpressed on the surface of several tumor types, including ovarian, lung, breast and gastric cancers. ZW33 is a drug-conjugated version of ZW25.The Company is looking for better possible treatment followed best results in patients suffering from ovarian cancer.

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