CLOZARIL BIWEEKLY BLOOD TESTS WOULD LEAD TO .4 MORE AGRANULOCYTOSIS CASES per 1,000 patient-years after six months of therapy compared to the current weekly blood cell monitoring schedule, according to a registry analysis presented by Novartis to FDA's Psychopharmacologic Drugs Advisory Committee July 14. The committee unanimously recommended the less frequent blood sampling after six months and voted 7-3 to allow monitoring after one year of therapy to be voluntary. No recommendation was made for when to discontinue blood cell counts for the antipsychotic.
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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.
