Genmab — Maj 2021
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This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Brazilian Health Regulatory Agency and United Kingdom’s Medicines and Healthcare products Regulatory Agency.
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I øvrigt nævner Janssen ikke Genmab eller Duobody med så meget som et halvt ord https://www.janssen.com/us/sites/www_janssen_com_usa/files/rybrevanttm_amivantamab-vmjw_receives_fda_approval_as_the_first_targeted_treatment_for_patients_with_non-small_cell_lung_cancer_with_egfr_exon_20_insertion_mutations.pdf
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God morgen.
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En subkutan version af amivantamab på vej https://meetinglibrary.asco.org/record/201164/abstract
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Sukker, ja det store Mariposa studie med 1000 pts har primary completion april 24. https://clinicaltrials.gov/ct2/show/NCT04487080?term=Amivantamab&draw=2&rank=4
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Gentogen, i ansøgningen fra 3. dec nævner de dog genmab. https://www.jnj.com/janssen-submits-application-to-u-s-fda-seeking-approval-of-amivantamab-for-the-treatment-of-patients-with-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations
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Phase I study investigating the safety of stereotactic body radiotherapy (SBRT) with anti-PD-1 and anti-IL-8 for the treatment of multiple metastases in advanced solid tumors. https://meetinglibrary.asco.org/record/201166/abstract
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Early stage. Jeg har i dag oprettet en
Proinvestor Youtube kanal. Her vil der fremover komme masser af interviews og præsentationer med biotekfirmaer. Til produktionen har jeg hyret et stærkt team ind som tidligere har arbejdet i bla. DR som studievært, videoproduktion og redigering. Sign up her: https://www.youtube.com/watch?v=teTBHPJusm0 -
PS: Giv vores første reklamevideo et like. På forhånd tak og forsat god pinse.
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Fra E L lagt i Aktiesnakken ved en fejl kl. 9,50: "JNJ's version of Amivantamab development" https://twitter.com/JNJNews/status/1395828935330607104
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Se mit svar i tråden fra JNJ.
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Tak Stroka. Jan beholder vi i vores vante Q&A format.
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Ungee tak for link. Der går de heller ikke så meget i detaljer kan jeg se.
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Ifølge patentet er opfinderne J. Neissen, P. Parren og J. Schumann samt M. Chiu (tidligere JN) og Moores (JNJ) (patent us 95 93 164). Og som Genmab (og EL) henviser til, kan udviklingshistorien læses her https://www.jbc.org/action/showPdf?pii=S0021-9258(21)00427-0
So I wasn't the only one to notice the absence of Genmab there...
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