Genmab — Januar 2020

[KWC]

Copenhagen, Denmark; January 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in Decemb

[KWC]

“With this approval, newly diagnosed patients with multiple myeloma who are eligible for ASCT may have the opportunity for treatment with a DARZALEX-containing regimen. We are extremely pleased that DARZALEX has received this latest approval and we look forward to the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone being launched in Europe,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on the Phase III CASSIOPEIA (MMY3006) study

[bikube]

Skidt med recepttallene denne gang, vi får det færdige resultat fra JnJ samme dag. Og dagens nyhed om godkendelse i EU må trække lidt op.

[bikube]

Orv - Kan du huske det Pensionisten.

[Bulder]

Det var hurtigt godkendelsen kom. Kun 5 uger og med jul og nytår ind imellem.

[E_L]

i was thinking the exact same. Nice.

[Bulder]

And with Alcyone approved 1½ years ago we now have both transplant and non-transplant covered in the EU. Will probably add up sales numbers in 2020.

[Bulder]

They submitted application March 27 last year. So all in all it took a little less than 10 mths.

[Solsen]

https://www.bbc.com/news/health-51182451 Endnu en historie omkring en kur imod cancer. Lad da håbe at det denne gang er rigtigt.

[peter12]

Såvidt jeg kan se er det en gammel historie fra Basel (og ikke Cardiff). Nok lettere tænkt end gjort ? https://elifesciences.org/articles/24476

[StockBull]

Morning Trend intact https://nbg1.your-objectstorage.com/proinvestor-dev/forum/boards/81007_trend_intact.JPG

[StockBull]

1.5 års trend +forecast (godt til CFD handel)

[StockBull]

[Helge_LarsenPI-redaktør]

God morgen.

[StockBull]

Den er er også meget sjov og man ser tydligt CWH er intakt https://nbg1.your-objectstorage.com/proinvestor-dev/forum/boards/81009_sjov.JPG

[Jørn_B]

@Stockbull. Tak... Lad os bare holde os til den sidste, så er jeg ikke utilfreds

[Bulder]

Ritzau skriver at Cassiopeia er godkendt i Japan. Det passer vist ikke. Jeg har ikke kunnet finde noget på Japan. I USA derimod er Cass godkendt. Til gengæld kan vi snart forvente godkendelse af Maia i Japan. Ansøgning 5. april.

[Bulder]

... sidste år, og da Alcyone tog 9-10 mdr i Japan, må det være lige oppe over.

[Bulder]

Har de overhovedet søgt på Cassiopeia i Japan? Jeg kan ikke finde noget. Andre?

[Darvin]

Kkjoel 15.32 and EL 15.51 - my estimates, based on exactly the same growth figures in the US as in 2019 and a sharp reduction in growth ROW will be 4.3 with upside to 4.4. I am lowering ROW growth to one third of growth in 2019. It should be said that SC can mean higher growth rates in 20 than in 19, but I did not take that into consideration, but instead use it to maintain the growth rate of 2019. If SC give an increased growth rate, we should probably go higher.