Genmab — Juli 2018

[mobbyduck1]

from positive CHMP, it is still gonna take 67 days to approval??

[Legolas23]

@Bulder ? @Sukkeralf ? @Solsen ?

[gentogen]

Det hedder, at "The PRAC is responsible for assessing all aspects of risk management of human medicines" , så umiddelbart ville jeg gætte på, at det lige passer med tidsplanen til næste CHMP i slutningen af juli

[gentogen]

og at de altså reelt afgør det.

[mobbyduck1]

men det tager stadig 67 dage til approval derfra ikke??

[StockBull]

Ser ud til shorterne er begyndt at reducere lidt: April snit 4.25% shortet. Maj 4.14%, Juni 3.84%

[Sukkeralf]

Mobby - jo ca 2 måneder

[Bulder]

Mest sandsynligt at hvis PRAC ingen indvendinger har, så kommer det på CHMPs næste møde, og i tilfælde af anbefaling, EU-godkendelse 60 dage senere.

[mobbyduck1]

så vi snakker sept/Okt i bedste fald?

[Bulder]

Ja slutningen af september. Men det reelle er jo CHMP's anbefaling, som så gerne skulle komme d. 27. ds. EU-godkendelsen er kun formel. Men det tager 60 dage at nå rundt i medlemslandene, som hver især skal godkende.

[Bulder]

I øvrigt udsender PRAC highlights på fredag. Kan være at der står noget om, hvad de indstiller til CHMP.

[JørgenVarnæs]

Tak Bulder. Det er også mit indtryk, at ema ikke fraviger deres procedurer for noget som helst. Når nu klokken blev stoppet på processen, så kan man ikke slippe billigere end med en måneds forsinkelse.

[bibob]

God morgen.

[transalp]

Go morgen:)

[Helge_LarsenPI-redaktør]

God morgen.

[Plimsoller]

God morgen

[saltpeter]

July 12, 2018 5:57 AM UTC
Genmab Enters Strategic Partnership with Immatics to Discover and Develop Next Generation Bispecific Cancer Immunotherapies

[saltpeter]

Genmab gains exclusive access to multiple novel proprietary tumor targets identified by Immatics Biotechnologies’ XPRESIDENT technology
Creation of novel immuno-oncology drugs combining Genmab and Immatics’ proprietary technologies
Genmab responsible for development, manufacturing and commercialization worldwide
Immatics to receive upfront payment of USD 54 million from Genmab

[saltpeter]

The deal strengthens Genmab’s position in immuno-oncology by combining Genmab's proprietary technologies and antibody know-how with Immatics' XPRESIDENT targets and T-cell receptor (TCR) capabilities. Genmab will receive an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or TCR-based bispecific therapeutic product

[saltpeter]

Genmab may elect to progress any resulting product candidates, and will be responsible for development, manufacturing and worldwide commercialization. For any products that are commercialized by Genmab, Immatics will have an option to limited co-promotion efforts in selected countries in the EU.