Genmab

	12/2 08:14 af Sukkeralf	Nogen der kender molecular templates - de har noget kørende både mod CD20 og CD38
	12/2 08:13 af Sukkeralf	(link)
	12/2 07:58 af Helge Larsen/PI-redaktør	Aktier: Pensionschefer tror på fortsat fremgang - GENT (link)
	12/2 07:54 af Helge Larsen/PI-redaktør	Fredagens aviser med Novo Nordisk, GN og Rockwool(link)
	12/2 07:53 af Helge Larsen/PI-redaktør	Asien: Kinesisk nytår holder de fleste markeder lukket - NY(link)
	12/2 07:53 af Helge Larsen/PI-redaktør	God morgen. :-)
	11/2 17:24 af E L	the 'Public summary of opinion on orphan designation: Teclistamab...' via (link)
	11/2 13:17 af E L	amivantamab in the EMA Report: Applications for new human medicines under evaluation by the CHMP: February 2021 . Start of evaluation 21-1-2021
	11/2 11:32 af kkjoel	Mange tak for link, Bulder - fint dokument (Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics) med god oversigtbarhed :-)
	11/2 10:26 af E L	Seit Montag, dem 1. Februar 2021 ist Kesimpta® (Ofatumumab) mit folgender Indikation in der Schweiz zugelassen: • Zur Behandlung von erwachsenen Patienten mit aktiven schubförmigen Verlaufsformen der Multiplen Sklerose (MS) ; small, but Novartis' home market
	11/2 09:57 af royal	Would be nice :-)
	11/2 09:51 af E L	@royal now more likely that 16:08 the day before yesterday is now also a good call ;-)
	11/2 09:39 af Bulder	(link)
	11/2 09:38 af Bulder	A priority review designation means FDA’s goal is to take action on the marketing application within 6 months of receipt.
	11/2 09:18 af Doublo	Livmoderhalskræft metastaserer ved til først til blære og/eller tarm, har jeg læst et sted, at man kunne overveje at inddrage bevacizumab?
	11/2 09:10 af GeorgeBest	Duoblo. Det er ikke ein behandling man bliver helbredt af, men en livstidsforlængelse på godt 8 mdr. i snit. Disse patienter har ikke andre muligheder, så for dem er 8 mdr. oveni godt. Behandlingen er givetvis dyr.
	11/2 09:08 af Sukkeralf	Lad os håbe på august !
	11/2 09:07 af Sukkeralf	Bulder er det ikke 6 måneder fra accept, som gerne tager et par måneder ?
	11/2 09:04 af Doublo	God morgen ved man noget om, i hvilken grad de kvinder der responderer på Tisotumab Vedotin bliver hjulpet, bliver nogen helbredt, eller er det markant livsforlængende. Er 24% contra under 15% en væsentlig forbedring i sådanne forsøg, og hvad sker der efter varighedsrespons på 8,3 mdr. skal de så have ny behandling? er det en dyr behandling? Hvor mange kvinder få livmoderhalskræft på verdensplan, der står kun hvor mange der dør af det, er det ubehandlet eller med kemo?
	11/2 08:59 af Bulder	Sukker, med PR bliver det senest i løbet af august.
	11/2 08:27 af Helge Larsen/PI-redaktør	Suveræn nyhed. :-) PS: Q&A med Jan er fastsat til d. 23. marts.
	11/2 08:26 af transalp	Go morgen. :) spænende nyheder..
	11/2 07:47 af Helge Larsen/PI-redaktør	Torsdagens danske avisuddrag med Vestas, Flying Tiger og FLSmidth(link)
	11/2 07:45 af Helge Larsen/PI-redaktør	Asien: Lav aktivitet og små udsving - store markeder holder lukket (link)

	11/2 07:15 af bibob	Dejlig nyhed. Nu også på MedWatch. (link)
	11/2 07:14 af bibob	God morgen. :-).
	11/2 00:15 af Sukkeralf	Bulder vel først i efteråret med mindre de får RTOR
	10/2 23:39 af royal	Nice call EL. :-)
	10/2 23:31 af Bulder	Så hvis det går igennem, er det godkendt til sommer.
	10/2 23:28 af Bulder	... seeking accelerated approval...
	10/2 23:26 af GeorgeBest	Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer (link)
	10/2 10:45 af E L	thanks ;-) So he confirms they are hoping for Tisotumab to be approved this year already, quite ambitious , we should see the filing any day now then i would think
	10/2 10:38 af JørgenVarnæs	Thank you so much StockBull - looks like Jan is vigilant in balancing risk/investment going forwards
	10/2 10:35 af StockBull	end of story :-)
	10/2 10:34 af StockBull	Pink Sheet, 11 Dec, 2020.) Amivantamab was developed using Genmab's DuoBody platform and licensed to Janssen. J&J has a full range of bispecific antibodies in development with Genmab, including teclistamab (BCMAxDC3) in early clinical development for relapsed refractory multiple myeloma and four more candidates in earlier trials. ADVERTISEMENT
	10/2 10:33 af StockBull	J&J recently submitted a biologic licensing application for a Genmab-developed bispecific antibody with the FDA. Amivantamab targets tumors with activating and resistant EGFR mutations and MET mutations. It is pending approval for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, whose tumors do not typically respond to standard of care. (Also see "Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL" -
	10/2 10:32 af StockBull	Bispecific antibodies are getting a lot of attention, although toxicity concerns remain. Genmab is developing a PD-L1x4-1BB bispecific antibody in early clinical testing in solid tumors in collaboration with BioNTech SE a collaboration dating back to 2015 that gives Genmab 50/50 commercial rights.
	10/2 10:32 af StockBull	The most advanced candidate in the deal with AbbVie is epcoritamab (CD3xCD20), which moved into Phase III testing in diffuse large B-cell lymphoma (DLBCL) early this year. (Also see "Genmab/AbbVie’s Epcoritamab Advances As Deal Bears Fruit" - Scrip, 14 Jan, 2021.) The deal also includes two other bispecific antibody candidates developed using Genmab's DuoHexaBody and DuoBody development platforms, which Genmab expects will continue to deliver drug candidates into the pipeline.
	10/2 10:32 af StockBull	"It's difficult to say right now which molecule it will be [that] we will hang onto 100%," he said. If it is a drug targeted to a smaller cancer indication that can be marketed optimally with a specialized sales force, then that would be an appropriate candidate to launch independently, but for a drug with broad reach like Darzalex, the exec explained Genmab will still look to partner, particularly because of the broad scope of the clinical development program.
	10/2 10:31 af StockBull	Wealthier biotechs are gaining new leverage when it comes to deal-making, van de Winkel added. "The dynamics between smaller biotech companies and bigger players is changing right now because some of the biotech companies, like Genmab, are very well capitalized." Genmab also plans to retain full ownership of some molecules, at least in the regions where it builds up a commercial presence.
	10/2 10:31 af StockBull	the products. (Also see "Genmab Lands Experienced Partner AbbVie In Broad Bispecific Antibody Collaboration" - Scrip, 10 Jun, 2020.) "At a minimum, we will ask for 50% co-ownership," van de Winkel said, pointing to the AbbVie partnership as an example of the kinds of deals Genmab hopes to mirror in the future. "That is one of the nice things about the AbbVie relationship, they were perfectly on board to do 50/50 with us.
	10/2 10:31 af StockBull	50/50 Deals At Least The company's commercial evolution will impact its partnering strategy going forward as Genmab looks to hold onto more commercial rights for its products and eventually launch drugs independently. For example, a rich $750m upfront deal the company signed last year with AbbVie Inc. to develop and commercialize three next-generation bispecific antibody candidates included co-commercialization rights in the US and Japan and an option to co-promote in other regions for two of th
	10/2 10:30 af StockBull	will be lean initially, though Genmab hasn't yet provided any specific details. "I spoke with my peers in the industry and it sometimes takes over 10 years before you have a good commercial infrastructure," van de Winkel said.
	10/2 10:30 af StockBull	Tepezza (teprotumumab) – and Genmab receives sales royalties on all of them. "This is probably one of our most exciting years ever for the company," CEO Jan van de Winkel said in a recent interview. "To become an end-to-end integrated biotech, a powerhouse, directly delivering new molecules to patients with the Genmab name on the vial is a big thrill for us." The company is taking a cautious, stepwise approach to building out a commercial organization, focusing on the US and Japan. The team wi
	10/2 10:29 af StockBull	cancer based on positive Phase II data. (Also see "Genmab And Seattle Genetics Progress Cervical Cancer ADC" - Scrip, 30 Jun, 2020.) It is a transitional year for Genmab as it begins to build out a commercial footprint for the first time. The Danish biotech has developed several drugs that have reached the market, but those drugs have been launched by the company's partners. They include Johnson & Johnson's Darzalex (daratumumab), Novartis AGs' Kesimpta (ofatumumab) and Horizon Therapeutics plc
	10/2 10:29 af StockBull	Several drugs developed by Genmab A/S are already on the market, but the company is planning to participate in its first commercial launch in 2021. Genmab is preparing for the US launch of the antibody-drug conjugate tisotumab vedotin for metastatic cervical cancer in the second half of the year in partnership with Seagen Inc. , if it is approved by the US Food and Drug Administration as expected. The companies plan to file tisotumab vedotin for accelerated approval for metastatic cervical canc
	10/2 10:28 af StockBull	I dont see any news in this article as such
	10/2 10:00 af JørgenVarnæs	Looks interesting...
	10/2 09:58 af E L	if anyone has access to scrip.pharmaintelligence.informa ; you can tell us if there is anything useful in this article ;) (link)
	10/2 09:51 af Helge Larsen/PI-redaktør	Aktier/tendens: Vild regnskabsdag med A.P. Møller-Mærsk og mange andre(link)