Genmab — Maj 2018
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God morgen.:-)
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Tak bibob...Sidder og skriver på min kommende investeringsbog. Genmab får sit helt eget kapitel.
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this old Ofa
study has results posted - Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL) - https://clinicaltrials.gov/ct2/history/NCT01191190?A=5&B=6&C=merged -
The DRd vs Rd Study Completion date 2 years earlier (why would they do that?) - https://clinicaltrials.gov/ct2/history/NCT02252172?A=45&B=46&C=merged
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E L, in June last year they changed it from 2022 to 2024. Now they have changed it back to 2022. At the same time (June last year) they changed the end of study from maximum up to 5 years to 7 years. But as it is "up to" I guess they have now found out that the 7 years are not necessary.
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Det bliver der bibob.
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the extent of cell lysis was highest with ofatumumab, followed by rituximab and ocrelizumab. Ongoing studies in other B-cell cytotoxicity assays will provide a broader overview regarding relevant MoAs.
Conclusions: The strong complement-dependent B-cell lysis by ofatumumab may contribute to its high potency in vivo that enables a low-dose subcutaneous dosing regimen.
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EMA:
The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for the following medicines:
• Daratumumab, EMEA-002152-PIP01-17, from Janssen-Cilag International N.V., for the treatment of lymphoid malignancies (except mature B-cell neoplasms); http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2018/05/WC500248882.pdf -
Recommendations for submission of supplementary information for Dara, signal Encephalopathy, to Assess in the next PSUR (submission by 24 July 2018) - http://www.ema.europa.eu/docs/en_GB/document_library/PRAC_recommendation_on_signal/2018/04/WC500247424.pdf p8
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another Tecentriq disappointment in colorectal cancer https://www.reuters.com/article/us-roche-immunotherapy/setback-to-roche-hopes-for-tecentriq-as-fails-key-cancer-trial-idUSKBN1IB16N
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