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Merck is withdrawing its accelerated approval application to the FDA for its blockbuster cancer drug Keytruda (pembrolizumab) for third-line treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, following disappointing study results. Read More
Prices for cancer drugs are higher when first introduced on the U.S. than in three wealthy European countries — Germany, Switzerland and England — and their prices tend to increase faster than inflation in the U.S. while decreasing in inflation-adjusted terms in the latter three nations, a new study found. Read More
Pharmaceutical companies, pharmacy benefits managers (PBMs) and hospitals are high on the target list of the Federal Trade Commission (FTC) as the agency moves to deepen its antitrust investigations into bad actors in certain industries over the next decade. Read More
The House Committee on Appropriations has advanced legislation to increase nonuser-fee funding to the FDA by $257 million to $3.45 billion in fiscal year 2022 and the fast-moving bill is on its way to the House floor with a vote expected in July — but there may be a few catches. Read More
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