Genmab — Juli 2019
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Martin Havtorn har før demonstreret en vis hang til det sensationsprægede. Hans overskrift er faktisk ikke rigtig: Selskabet har nu udsendt advarsler til alverdens sundhedsmyndigheder .. - Det gjorde de for flere mdr. siden. Her f.eks. NZ: https://medsafe.govt.nz/safety/DHCPLetters/DarzalexMarch2019.pdf
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U.S. Food and Drug Administration has approved oral XPOVIO in combination with dexamethasone for the treatment of relapsed or refactory multiple myeloma in adult patients. Karyopharm expects XPOVIO to become commercially available in the U.S. on or before July 10, 2019.
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Hvad mon det kommer til at betyde for Genmab?
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ok
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The news of the approval was clearly a surprise to investors, sending Karyopharm's stock shooting up about 40%. The FDA's final decision is at odds with that of the Oncologic Drug's Advisory Committee (ODAC), which had voted 8-5 against recommending approval and instead advocated waiting for results from the ongoing Phase III BOSTON trial.
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The FDA granted accelerated approval to Karyopharm's application for Xpovio (selinexor) as a treatment for multiple myeloma (MM) in patients refractory to at least two proteasome inhibitors, two immunomodulators, and an anti-CD38 monoclonal antibody
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