Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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The approval of the combination marks a first for the U.S. market. The combination of AbbVie and Janssen’s Imbruvica with Roche’s Gazyva is the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy, AbbVie said this morning.
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.