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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.
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 ...
Since the market for any drug with such a limited application scope would, by definition, be small and thus largely unprofitable, government intervention is often required to motivate a manufacturer to address the need for an orphan drug. The intervention by government on behalf of orphan drug development can take a variety of forms: Tax ...
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 ...
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.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Fairness in Orphan Drug Exclusivity Act: To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. H.R. 1667: March 8, 2021: Dr. Lorna Breen Health Care Provider Protection Act: To address behavioral health and well-being among health care professionals.
Corcoran died at 12:44 a.m. CST after being given a lethal dose of pentobarbital, a drug separately used to manage seizures and insomnia, according to the Indiana Department of Correction.