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Pamrevlumab (INN; [1] development code FG-3019) is a humanized monoclonal antibody designed for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer. It binds to the connective tissue growth factor (CTGF) protein. [2] This drug was developed by FibroGen, Inc. [3]
The U.S. Food and Drug Administration (FDA) granted orphan drug designations in 2010 and 2020, [9] [10] and breakthrough therapy designation in 2016, on the basis of preliminary data from the phase II trial.
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The ...
Orphan drug status, which is given to drugs meant for the treatment of rare diseases, offers drug developers a path to faster approval and enhanced market exclusivity. So let's look at a small ...
BioMarin Pharmaceuticals (NAS: BMRN) keeps chugging along, pushing its orphan drug pipeline forward. Yesterday, the biotech announced data from two trials, giving the company confidence to move ...
Protalix BioTherapeutics , an Israeli company focused on the treatment of Gaucher disease and other rare diseases, recently reported its third-quarter earnings. But its core business -- a joint ...
It has received orphan drug designation by the European Medicines Agency (EMA) for the treatment of gastric cancer in January 2017. [8] The US Food and Drug Administration (FDA) approved it in March 2017, for the treatment of Merkel-cell carcinoma , [ 7 ] an aggressive type of skin cancer.
In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alpha antagonists were ineffective or could not be tolerated, vedolizumab was shown to be more effective than placebo: 15% (32 out of 220) of patients receiving vedolizumab showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on ...