FDA
The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.
The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration grows more incapable of reviewing some medications for approval.
The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.
The Orphan Drug Act (ODA) was enacted on January 4, 1983. It was designed to encourage the development of drugs for rare diseases. The law was amended the following year to define rare diseases as ones that affect fewer than 200,000 people in the U.S. But it also included drugs that affect more than 200,000 people the costs of developing and marketing the drug in the U.S. would exceed revenue from U.S. sales.
Because of the government shutdown, which as of Monday, January 14 is into its fourth week, 40 percent of the U.S. FDA employees were furloughed. However, the two approvals described here should still be on track.
Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
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Neos Therapeutics, Inc. announced that it has entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA, Inc. to resolve all ongoing litigation involving Neos’ patents protecting its Cotempla XR-ODT® extended-release orally disintegrating tablets and Teva’s Abbreviated New Drug Application filed with the U.S. Food and Drug Administration to market a generic version of that product.
First and Only FDA-Approved Inhaled Levodopa for Intermittent Treatment of OFF Episodes in People with Parkinson’s Taking Carbidopa/Levodopa
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