Postmarket research
Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
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.
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The United Kingdom is calling for greater clinical trial transparency after a government committee released a report that indicates that data from about half of all clinical trials in that country are not published, raising concerns over research integrity and risks to human health.
A report recently published by the National Academies of Sciences, Engineering, and Medicine concluded that institutions and researchers should regularly and carefully evaluate whether and how to provide study results to participants.
Genentech’s hemophilia treatment Hemlibra continues to demonstrate its efficacy in treating patients. New late-stage data presented at World Federation of Hemophilia 2018 World Congress shows the drug significantly reduced treated bleeds in a broad patient population in two separate studies.
At the World Medical Innovation Forum, panelists observed that AI can be used to scour old clinical trial data for new applications and possibly take over part of clinical trials in “virtual” models.
Analysts look at what else AbbVie has in the pipeline after Rova-T Failure.
But the biotech swiftly indicated that it doesn’t expect the halt to last for long.
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