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Eliquis Clinical Development
A timeline chronicling the development history of Bristol-Myers Squibb/Pfizer’s apixaban.
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Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.
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Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.
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Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
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The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.
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New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
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US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.
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The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.