Genmab — Marts 2020
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EMA agenda this week, Day 180 list of
outstanding issues: 4.2.1. Darzalex - daratumumab - Orphan - Scope: “Extension application to introduce a new pharmaceutical form (solution for
injection), a new strength (1800 mg) and a new route of administration (subcutaneous
route).”
Action: For adoption -
i don't think so, probably more questions for JNJ
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step -but i would be happy to be wrong here... -
God morgen
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God morgen.
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From Novartis: At this time, we do not anticipate any delays to regulatory submissions.
Upcoming launches of ofatumumab, capmatinib, inclisiran all filed with respective health authorities.
Pre-launch activities continue as planned.
Ofatumumab is manufactured in Switzerland https://www.novartis.com/sites/www.novartis.com/files/novartis-frequently-asked-questions-covid-19.pdf -
The most problematic in my opinion is Genmabs CD20/CD3 - if it gets delayed due to hard times starting new clinical trials. Maybe even more important now to get a partner deal and BP on board. They can spend time planning and stuff while the Corona virus slow things down
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