Genmab — September 2020

[kkjoel]

Og ja, nu må GEN da have en begrænset periode at melde tilbage til ADC. Oprindeligt havde de hvor lang tid efter data-release?

[kkjoel]

Og vedr. AL) Amyloidosis: "The U.S. FDA will review the application under their Real-Time Oncology Review (RTOR) pilot program and Project Orbis."

[kkjoel]

Meget positivt - giver jo kortere behandlingstid: "About the RTOR Pilot Program1 and Project Orbis2
The aim of the RTOR pilot program is to explore a more efficient review process for supplemental New Drug Applications (sNDAs) and sBLAs to provide safe and effective treatments to patients as early as possible. Inclusion in the RTOR pilot program does not guarantee or increase the probability of approval of this sBLA."

[kkjoel]

.. "Project Orbis is an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners."

[E_L]

from the SEC document,
i thought they should have made the decisoin already on Cami in aug, but may be delayed by the temporary trial halt or Covid. Jan did not answer that question.

[E_L]

Now all we need is Lagarde to tell us they now will start buying biotech stocks to stimulate the economy. Specially Danish ones

[gentogen]

The Cami article looks very interesting but it is based on preclinical models so not as such new data

[E_L]

Genmab’s inaugural appearance in Forbes’ annual ranking of the world’s 2000 largest public companies https://twitter.com/Genmab/status/1304057290086125568

[KWC]

Er denne allerede postet ?

[KWC]

Takeda's Ninlaro Stumbles in Latest Multiple Myeloma Trial

Published: Sep 10, 2020

[KWC]

https://www.biospace.com/article/takeda-s-ninlaro-misses-mark-in-multiple-myeloma-trial/?utm_campaign=Daily Article&utm_content=139589453&utm_medium=social&utm_source=facebook&hss_channel=fbp-10530620221

[transalp]

Go morgen..

[Helge_LarsenPI-redaktør]

God morgen

[Helge_LarsenPI-redaktør]

TA Genmab: https://www.proinvestor.com/index.php?p=debat_1&postid=86703

[bibob]

Sc Dara in AL . https://www.onclive.com/view/fda-approval-sought-for-subcutaneous-daratumumab-in-al-amyloidosis?utm_source=sfmc&utm_medium=email&utm_campaign=9-10-20_EXE-19-OGD0724_OncLiveSS_RCC CC eNews_Cabometyx_NON_US_Send&eKey=

[Sukkeralf]

Without exaggeration, this is the most significant filing in the modern history of therapeutic developments for patients with AL amyloidosis,” Raymond L. Comenzo, MD, director of the John C. Davis Myeloma and Amyloid Program at Tufts Medical Center told OncLive.

[E_L]

the Camidanlumab article referred to yesterday - CD25-targeted antibody–drug conjugate depletes regulatory T cells and eliminates established syngeneic tumors via antitumor immunity -
https://jitc.bmj.com/content/8/2/e000860 (preclinical as gentogen correctly noted)

[E_L]

Genmab
@Genmab

We are proud of our antibody platforms. Read an article published in the JCO on DuoBody-CD3×CD20, a #BispecificAntibody created using DuoBody technology with the potential to create novel therapies for lymphoma https://twitter.com/Genmab/status/1304344075747942400

[E_L]

it is a repeat of the ASCO data

[gentogen]

Using health care claims databases, our analysis indicates that the adjusted (unadjusted) prevalence of AL amyloidosis increased significantly from 20.1 (15.5) cases per million in 2007 to 50.1 (40.5) cases per million in 2015, an annual percentage change of 12% (11.9%)