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Biogen and the FDA failed to convince an advisory committee in a crucial meeting Friday that the company’s potential blockbuster Alzheimer’s drug aducanumab has shown enough evidence of effectiveness. Read More
Although specialty drugs make up only a small fraction of the total retail prescriptions filled in the U.S., they accounted for 37.7 percent of retail and mail-order prescription net spending from 2016 to 2017 even with rebates factored in, a new analysis has found. Read More
The FDA is expected to support Biogen’s potential blockbuster Alzheimer’s drug aducanumab today in a crucial advisory committee meeting today. Read More
The bitterly fought U.S. presidential battle may drag on for some time if the results are contested, but should Democrat Joe Biden emerge victorious, his administration is expected to take a more hands-off approach to the FDA on COVID-19 vaccines and therapeutics. Read More
Many of the guidance documents for drug developers and manufacturers that the FDA has issued during the COVID-19 pandemic are likely to continue to be in effect long after the public health emergency has passed, said Keith Webber, a former official in the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Read More
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Read More
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