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11/9 07:18 af Helge Larsen/PI-redaktør |
God morgen :-)
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11/9 06:18 af transalp |
Go morgen.. :)
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10/9 20:11 af KWC |
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10/9 20:10 af KWC |
Takeda's Ninlaro Stumbles in Latest Multiple Myeloma Trial
Published: Sep 10, 2020
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10/9 20:09 af KWC |
Er denne allerede postet ?
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10/9 16:05 af E L |
Genmab’s inaugural appearance in Forbes’ annual ranking of the world’s 2000 largest public companies (link)
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10/9 14:27 af gentogen |
The Cami article looks very interesting but it is based on preclinical models so not as such new data
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10/9 14:24 af 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 ;-)
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10/9 14:23 af 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.
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10/9 14:20 af 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."
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10/9 14:19 af 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."
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10/9 14:19 af 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."
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10/9 14:16 af 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?
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10/9 14:15 af kkjoel |
Absolutely :-)
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10/9 14:15 af E L |
it is great news, and worthy of repeating a few times ;-)
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10/9 14:14 af Plimsoller |
Det var blot en joke :-)
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10/9 14:13 af kkjoel |
Dejligt, Plims!
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10/9 14:13 af kkjoel |
Ups. Nyheden var kommet her allerede. Sorry.
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10/9 14:13 af Plimsoller |
Det startede den med kl. 13:54 da E L postede nyheden første gang ;-)
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10/9 14:13 af E L |
Jan dodged the question on increasing the participation in Cami-T last Q&A, but i expect with data out, they will have to make a decision soon?
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10/9 14:12 af kkjoel |
Sådan! Mon ikke kursen vil udvise en stigende tendens resten af dagen...!? ;-)
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10/9 14:11 af kkjoel |
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10/9 14:11 af kkjoel |
Genmab Announces that Janssen has Submitted a Supplemental Biologics License Application to U.S. FDA for use of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in Patients with Light-chain (AL) Amyloidosis.
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10/9 14:10 af E L |
Data demonstrated that single low doses of the CD25-targeted ADC resulted in potent and durable antitumor activity against established CD25-negative solid tumors with infiltrating Tregs, both as a monotherapy and in combination with an anti-PD1 checkpoint inhibitor.
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10/9 14:10 af E L |
The study evaluated the antitumor activity of a pyrrolobenzodiazepine (PBD) dimer-based, CD25-targeted ADC, either alone or in combination with a checkpoint inhibitor, in CD25-negative syngeneic colon cancer models that exhibit tumor infiltration of CD25-expressing regulatory T cells (Tregs).
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10/9 14:08 af E L |
ADC Therapeutics Announces Publication Highlighting the Potential of Camidanlumab Tesirine (Cami) as a Novel Immuno-oncology Approach for Solid Tumor Cancers
Preclinical study published in the Journal for ImmunoTherapy of Cancer supports continued evaluation of CD25-targeted ADC in Phase 1b clinical trial in selected advanced solid tumors (link)
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10/9 14:07 af E L |
;-)
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10/9 14:07 af Sukkeralf |
Lets beat the record time for approval please :-)
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10/9 14:06 af Sukkeralf |
wauu - nice :-)
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10/9 13:56 af E L |
The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program,
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10/9 13:55 af E L |
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10/9 13:54 af E L |
Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis
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10/9 13:04 af Sukkeralf |
The trial did not meet the threshold for statistical significance and the primary endpoint of PFS was not met.
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10/9 13:04 af Sukkeralf |
The study found the addition of NINLARO to lenalidomide and dexamethasone resulted in a 13.5 month increase in median progression-free survival (PFS) (35.3 months in the NINLARO arm, compared to 21.8 months in the placebo arm
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10/9 13:03 af Sukkeralf |
test
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10/9 13:02 af Sukkeralf |
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10/9 11:59 af StockBull |
(link) mulig kursudvikling kommende måned såfremt markedet opføre sig pænt
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10/9 09:36 af Topo |
Jeg skylder sgu dig en øl for dit skriv om qfuel Mcjean :)
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10/9 09:29 af Mcjean |
:-) Whole new business my friend, you better join
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10/9 09:20 af E L |
E L from Genmabchat thinks he missed that -plastic- boat ;-) But he says that if he can sell his Genmabs at 18.000 he may look into it again :-D
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10/9 08:44 af Mcjean |
Maybe now E L from Genmabchat will join the adventure and use some of his huge energy in this stock, because now Qfuel arrive to netherland:-D
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10/9 06:45 af transalp |
Go morgen.. :)
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9/9 17:30 af E L |
If anyone is interested in a position as postdoctoral dara researcher with dr. Niels van Donk
- (link)
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9/9 17:15 af Solsen |
I like that ;-)
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9/9 16:21 af E L |
BAML sees Kesimpta in MS $5bn peak sales $5bn
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9/9 16:10 af Helge Larsen/PI-redaktør |
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9/9 15:57 af E L |
New: Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL (link)
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9/9 15:57 af E L |
yes, CD47 is clearly the hot target atm. Genmab better hurry, you 'Blink' and you miss your opportunity ;-)
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9/9 15:54 af E L |
they are also presenting at Citi this week, not sure if we can see anything from that
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9/9 14:54 af GeorgeBest |
Genmab to present at Morgan Stanley event 15.9.20. Webcast will be available (link)
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