Genmab — Marts 2020
-
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
-
God morgen.
-
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
-
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind