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An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The former executives have been charged with initiating kickback schemes, as well as falsifying data, to increase sales of its powerful opioid Subsys.
Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
On Thursday, regulators with both the FDA and EMA announced that patients prescribed the drug should ask their doctors if it is wise to continue taking it. This comes after Lartruvo failed to hit endpoints in a Phase III study of advanced or metastatic soft tissue sarcoma.
This week, the U.S. Supreme Court rejected Swiss pharmaceutical company Helsinn Healthcare S.A.’s claim that Teva Pharmaceutical violated patent rights when the Israel-based company released a generic version of its anti-nausea medicine, Aloxi.
Once the user fees run out, the employees paid by them will be furloughed if the government doesn’t get back to work. There are numerous companies with PDUFA dates later than the dates that have been noted.
As the United Kingdom nears closer and closer to exiting the European Union without a deal, drug manufacturers like Novartis are preparing contingencies for how they will continue to provide medications, many of them life-saving, for patients in the U.K.
UnitedHealth Group’s Optum unit is suing David Smith, a former information technology executive, for breach of contract. They note that Smith, in the 18 months before his resignation, played a pivotal role in reviewing Optum’s strategy, and was “one of fewer than 50 people at the company” with access to Optum’s detailed profit-and-loss statements.
San Diego-based Gossamer Bio is pulling the trigger on an initial public offering by harnessing a legal loophole that will allow the company to move forward with its listing plans despite the partial government shutdown, now in its 34th day.
It’s no secret that the pharmaceutical industry spends a significant amount of money lobbying state and federal governments to gain leverage that will benefit individual companies and the industry overall.
No safety issues were cited. Instead, it appears related to the company’s proposal to modify the trial’s analysis plan and various chemistry, manufacturing and controls (CMC) issues.