Genmab — April 2020
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Remdesivir: science remains equivocal about whether this drug actually works for covid-19 sufferers. Two trials in China have already failed, because of lack of enrolment. (China started its trials relatively late in its epidemic, so it was hard to recruit sufficient numbers of patients.) The recent publication in the New England Journal of Medicine, of a study of remdesivir given to 53 severely afflicted patients, reported that 68% of them improved.
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However the study has proven divisive among scientists. To begin with, errors can be large given the small number of patients. Moreover, the trial was not “randomised”, so there is no way of knowing whether the sample properly reflects the population of severely afflicted patients. Last, there was no comparison group that was given a placebo, ie, a substance with no therapeutic effect, to establish the real effectiveness of the drug.
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For all the excitement it generated, the STAT report was little more than a leaked conversation between doctors. It revolved around a trial at the University of Chicago with 125 patients, mostly severely ill with covid-19. One of the doctors is reported as saying that most of the patients had been discharged and only two had died. But even if this is correct, the lack of a placebo group makes it hard to assess the real worth of the drug. The University of Chicago itself warned that drawing any
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Even if the drug proves successful, it is still experimental, and only limited quantities of such drugs are usually available. Gilead has increased production to meet demand for use in trials. On April 5th, it said it had enough to supply more than 140,000 patients.
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These sorts of numbers are larger than would be required by clinical trials, so suggest that Gilead is ramping up production for clinical use. The firm also said it was hoping to increase output again as raw materials became available. Looking further ahead, at even broader use, the firm has set an “ambitious goal” of producing more than 500,000 treatment courses by October, and 1m by the end of the year, from a geographically diverse group of suppliers.
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Genmab tilbage i kanalen https://nbg1.your-objectstorage.com/proinvestor-dev/forum/boards/83827_April_18_genmab.JPG
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Link til Twitter, virker hos mig.
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Amyloidosis: Safety Run-in trial of Phase 3 Dara-CYBORDE trial showed 82% >VGPR with high renal organ response rate https://twitter.com/slentzsch/status/1251703290598916099?s=21
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https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(20)30143-9/fulltext
Evolving role of Daratumumab: From backbencher to a frontline agent https://sci-hub.tw/https://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(20)30143-9/fulltext -
US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time https://www.finanzen.ch/nachrichten/aktien/us-fda-and-ema-accept-applications-for-roches-ocrevus-ocrelizumab-shorter-2-hour-infusion-time-1029105760
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Novartis starting a new "An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab (ARTIOS)" https://www.clinicaltrials.gov/ct2/show/NCT04353492?cond=Multiple+Sclerosis&sfpd_s=04%2F06%2F2020&sfpd_d=14&sel_rss=new14
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