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The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
Novartis has announced that effective Nov. 16, it will remove discounts for hospitals enrolled in the 340B Drug Pricing Program for products dispensed at pharmacies that are more than 40 miles from a hospital’s main facility. Read More
In an unusual move, the FDA has removed an advisory committee member temporarily, just days before a critical vote on an investigational treatment for Alzheimer’s disease. Read More
Gilead Sciences says it has no plans to relinquish the Priority Review voucher it earned from the FDA’s approval of remdesivir as a COVID-19 treatment despite urging from a consumer advocacy group that argued the company is earning more than is reasonable from the antiviral. Read More
Pfizer said it intends to handle the distribution of its COVID-19 vaccine itself after the federal government’s initial distribution to priority populations is completed. Read More
A Russian drugmaker has asked the Kremlin for a compulsory license allowing it to manufacture a generic of Gilead Sciences’ antiviral drug remdesivir. Read More
Sanofi and Regeneron have prevailed in a European patent ruling that protects their co-marketed cholesterol-lowering drug Praluent (alirocumab). Read More
The FDA has released a list of 223 drugs and medical countermeasures (MCMs) that it considers vital to U.S. patients or critical in a public health emergency, fulfilling a requirement of an executive order issued by President Trump in August. Read More
A growing number of states say they don’t plan to automatically distribute FDA-approved COVID-19 vaccines to their residents. Nevada, Oregon and Washington announced last week that they plan to conduct independent verification before distributing any vaccines. Read More