GlaxoSmithKline and Genmab gambled that by submitting a pivotal trial including both chronic lymphocytic leukemia patients refractory to two standard therapies and patients refractory to only one of them, fludarabine, but who also had bulky lymphadenopathy, they could garner a broader indication for Arzerra (ofatumumab), despite advice from FDA that the two groups could not be combined for one indication
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
