Dendreon's therapeutic cancer vaccine Provenge is the first of its kind to make it to an FDA advisory committee. The committee gave the novel agent a thumbs up. But FDA may disagree and turn away the prostate cancer vaccine until there is more conclusive data of its safety and effectiveness. How much does Dendreon stand to lose?
By Ramsey Baghdadi
In an industry where all drug approvals and rejections are put under the microscope, Dendreon Corp. ’s therapeutic cancer vaccine...
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The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
