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The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
Since taking over the helm of GlaxoSmithKline in 2017, Chief Executive Officer Emma Walmsley has made some significant moves to redefine the company as one focused on the development of pharmaceuticals.
The former executives have been charged with initiating kickback schemes, as well as falsifying data, to increase sales of its powerful opioid Subsys.
Taiwan Liposome Company, Ltd. announced the appointment of George Spencer-Green, MD, MS, as TLC’s new Chief Medical Officer.
As the chief executive officer of Ovid Therapeutics, Jeremy Levin has a lot on his plate. But, there is one thing always in the forefront of Levin’s mind – the patients his company can serve.
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.
Movers and Shakers is BioSpace’s weekly roundup of leadership appointments and changes within the biopharma world. Included this week are Genentech, Editas, Sage, Sangamo, and more.
After Bill Anderson moved from the role of Genentech chief executive officer to helm parent company Roche’s division Roche Pharmaceuticals earlier this month, the South San Francisco-based subsidiary has operated without a top executive – until now.
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.
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