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Many drugmakers complained to ERG about being unable to regularly meet with FDA officials to discuss patient experience data during product development. Read More
From the lessons learned in the COVID-19 pandemic, the FDA intends to push for greater use of master protocols, decentralized trials and digital health technology moving forward, Acting Commissioner Janet Woodcock and other top agency officials said yesterday. Read More
There were fewer U.S. drug shortages in 2020 but more work is needed to improve the supply chain’s resiliency, the FDA said in a new report to Congress. Read More
The Centers for Medicare and Medicaid Services may be demanding transparency in pricing from hospitals, but it isn’t working very well, according to GoodRx. Read More
A federal judge in Delaware has ruled that AstraZeneca’s lawsuit against HHS can go ahead despite the department’s withdrawal of an advisory opinion mandating that drugmakers offer 340B drug discounts to contract pharmacies. Read More
Regeneron’s successful Biologics License Application (BLA) for its Ebola treatment Inmazeb last October was an example of the FDA’s new integrated-review process in action, an agency official said yesterday at the Drug Information Association’s annual meeting. Read More
The EMA, which plans to expand its preferred list to include 10 treatments, released the list for use by regulatory authorities in EU member states. Read More
The FDA is increasingly using patient experience data when approving new drugs or biologics, but the agency’s use of the data “varies widely,” an agency-commissioned report concluded. Read More
The FDA’s three-year-old pilot program on model-informed drug development (MIDD) has attracted more demand from industry than it can accommodate, an agency official said yesterday. Read More
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium and sodium oxybates) has earned the FDA’s coveted seven-year orphan drug exclusivity for treating cataplexy or excessive daytime sleepiness in narcolepsy patients age seven years and up. The exclusivity is a big win for the company, which already has a narcolepsy cash cow on the market. Read More
The Institute for Clinical and Economic Review (ICER) has revised upward what it thinks Biogen’s controversial Alzheimer’s disease treatment Aduhelm (aducanumab) ought to cost, but the new estimate is still only a fraction of the $56,000 a year the company proposes to charge. Read More