Articles by Anna Rose Welch
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FDA News Roundup: Teva, AstraZeneca, Amgen, Medicines Company, And More
4/17/2015
What FDA decisions did you miss this week?
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Takeda's Velcade Replacement: Future Patient-Centric Blockbuster?
4/10/2015
Last month, right before the approval of the first U.S. biosimilar, Amgen announced a victory for its myeloma drug, Kyprolis. In the Phase 3 ENDEAVOR clinical trial, injectable Kyprolis, taken in combination with low-dose dexamethasone, outperformed Takeda’s rival injectable Velcade plus dexamethasone. Multiple myeloma patients lived twice as long without their disease worsening when taking Kyprolis. However, recent news suggests Takeda isn’t backing down without a fight.
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FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More
4/10/2015
What FDA decisions did you miss this week?
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FDA News Roundup: AstraZeneca, Teva, Amgen, And More
4/2/2015
What regulatory decisions did you miss this week?
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FDA, EMA Drug Approval Stats: Are We Measuring Success The Wrong Way?
3/27/2015
While approval stats spark declarations of excitement from each regulatory agency and make news headlines, the differences in approval times in particular aren’t necessarily a cause for celebration; rather, they illuminate something much more concerning about the state of global drug development.
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FDA News Roundup: Merck, Actavis, Vertex, And More
3/20/2015
What FDA decisions did you miss this week?
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“Virtual” Recruitment Roundtable: Disruptive Innovation In Clinical Trials
3/17/2015
In the final installment of this "virtual" recruitment roundtable series, Clinical Leader’s recruitment experts home in on some of the most disruptive recruitment solutions in the industry today, as well as highlight some of the ways pharma could continue to innovate in order to streamline recruitment in the future.
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Paying Clinical Trial Participants: Best Or Worst Practice?
3/13/2015
Last week in my blog about the wacky legends healthy clinical trial volunteers tell in the clinic, I was particularly struck by the risks patients were supposedly willing to take for a large stipend. The impact of payments in clinical trials has been a topic I’ve noticed circulating through the industry over the past few weeks — especially in the case of H.I.V. trials.
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FDA News Roundup: Bristol-Myers Squibb, Bayer, Astellas, And More
3/11/2015
What FDA decisions have you missed in the last week?
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“Virtual” Recruitment Roundtable: How To Bolster Clinical Trial Patient Education
3/10/2015
A lack of education is one of the biggest roadblocks to improving clinical trial recruitment. In this portion of Clinical Leader’s “virtual” roundtable, our recruitment experts chime in on the effects lack of education has had on the global clinical trial industry and present some strategies that pharma can take to ensure prospective patients realize the benefits of enrolling in a trial.