Government
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.
A documentary about Theranos will be shown at Sundance, while ABC News will unveil its own documentary on the company this week.
Translate Bio did not provide information as to what questions or concerns the FDA has regarding the planned early-stage trial for mRT5201.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.
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