News Focus
News Focus
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marzan

12/04/21 6:10 AM

#423778 RE: biosectinvestor #423768

We are in the accelerated mode while NVCR is decelerated rapidly; coming weeks might show the difference much more, imo.
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Lykiri

12/04/21 6:37 AM

#423780 RE: biosectinvestor #423768

About Project Orbis:
Recent numbers- MHRA

11 Application Submissions
1 Regulatory Action

May 7, 2021
AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.
https://www.pharmatimes.com/news/az_tagrisso_first_to_win_mhra_approval_under_project_orbis_1369493



FDA Perspective

ASH Scientific Workshop on Streamlining Hematology Clinical Trials.
December 10, 2021
Angelo de Claro_FDA
Associate Director for Global Clinical Sciences
Oncology Center of Excellence (OCE)
Division Director for the Division of Haematologic Malignancies I
Center for Drug Evaluation and Research
U.S.Food and Drug Administration


Perspective_Scientific Workshop
Uploaded: Friday, November 26, 2021 at 2:35 PM EST
Min. 6:37

https://vimeo.com/650419152