I starten var vi kun genmabbere, nu er vi blandt en større flok.
I dag var 2 måneders fristen for FDA. Så nu bliver det spændende hvad og hvornår der bliver meldt ud og hvilke milestones vi får.
I dag var 2 måneders fristen for FDA. Så nu bliver det spændende hvad og hvornår der bliver meldt ud og hvilke milestones vi får.
1/4 2009 08:53 tumult 0
6547 Der er gået 2 måneder, men ikke 60 dage da der kun var 28 dage i februar, så det er vel først i morgen, hvis det skal være helt rigtigt.
1/4 2009 12:51 collersteen 06582 Ifølge frk. (fru?) Husted er fristen udløbet natten til idag.
4/1/2009 10:48:44 - RB-Borsen
Genmab: FDA godkendelse og milestone betaling på trapperne
Investorerne afventer en melding fra Genmab om milestonebetaling fra
Glaxosmithkline vedrørende godkendelsen af Arzerra CLL i USA.
Det er to måneder siden at Genmab ansøgte de amerikanske
sundhedsmyndigheder, FDA, om godkendelse af Arzerra, hvilket skal bane vejen
for lancering af medikamentet. Deadline for FDA's tilbagemelding er nu
overskredet, hvilket betyder, at godkendelsen er i hus, og dermed er
Glaxosmithkline milestone betaling også i hus for Genmab.
- Glaxosmithklines milestonebetaling lyder på 50-75 mio. dollar, og Genmab
må komme med en melding om den konkrete betaling nu når deadline for FDA er
udløbet. Yderligere bliver det spændende at høre om, Genmab får en "accelerated
review", hvilket kan betyde, at Arzerra kan lanceres indenfor fire måneder.
Alternativet er en lancering indenfor ti måneder, udtaler aktieanalytiker Rune
Majlund Dahl fra Sydbank til RB-Børsen.
Analytikeren hæfter sig ved, at Genmab er forpligtiget til at fremlægge
oplysningerne, når de er bekendte, så meldingen må være på trapperne.
Yderligere venter Rune Majlund Dahl, at Arzerra får "accelerated review" af
FDA.
Genmab oplyser Arzerra-ansøgningen blev indsendt den 30. januar.
-Efter at ansøgningen er indsendt har FDA 60 dage til at komme med
bemærkninger, og den deadline er dermed udløbet natten til onsdag, udtaler Vice
President, Investor Relations Helle Husted fra genmab til RB-Børsen.
4/1/2009 10:48:44 - RB-Borsen
Genmab: FDA godkendelse og milestone betaling på trapperne
Investorerne afventer en melding fra Genmab om milestonebetaling fra
Glaxosmithkline vedrørende godkendelsen af Arzerra CLL i USA.
Det er to måneder siden at Genmab ansøgte de amerikanske
sundhedsmyndigheder, FDA, om godkendelse af Arzerra, hvilket skal bane vejen
for lancering af medikamentet. Deadline for FDA's tilbagemelding er nu
overskredet, hvilket betyder, at godkendelsen er i hus, og dermed er
Glaxosmithkline milestone betaling også i hus for Genmab.
- Glaxosmithklines milestonebetaling lyder på 50-75 mio. dollar, og Genmab
må komme med en melding om den konkrete betaling nu når deadline for FDA er
udløbet. Yderligere bliver det spændende at høre om, Genmab får en "accelerated
review", hvilket kan betyde, at Arzerra kan lanceres indenfor fire måneder.
Alternativet er en lancering indenfor ti måneder, udtaler aktieanalytiker Rune
Majlund Dahl fra Sydbank til RB-Børsen.
Analytikeren hæfter sig ved, at Genmab er forpligtiget til at fremlægge
oplysningerne, når de er bekendte, så meldingen må være på trapperne.
Yderligere venter Rune Majlund Dahl, at Arzerra får "accelerated review" af
FDA.
Genmab oplyser Arzerra-ansøgningen blev indsendt den 30. januar.
-Efter at ansøgningen er indsendt har FDA 60 dage til at komme med
bemærkninger, og den deadline er dermed udløbet natten til onsdag, udtaler Vice
President, Investor Relations Helle Husted fra genmab til RB-Børsen.
Ok og det er vel ingen aprilsnar. Det er da nyheder at milestone er 50-75 mio dollar.
1/4 2009 13:12 Stinker 06586 Det er godt nok ikke særlig tillidsvækkende, at hvor det tidligere var "fast track" og "priority review", der blev sammenblandet, så har analytikeren nu opfundet en hybrid mellem "priority review" og "accelerated approval".
Men man må vel antage, at han med den tilsyneladende hjemmestrikkede terminologi "accelerated review" slet og ret mener "priority review" og så i øvrigt håbe, at den forvirring, der i forvejen har hersket omkring forløbet, ikke genopstår.
Men man må vel antage, at han med den tilsyneladende hjemmestrikkede terminologi "accelerated review" slet og ret mener "priority review" og så i øvrigt håbe, at den forvirring, der i forvejen har hersket omkring forløbet, ikke genopstår.
1/4 2009 13:15 collersteen 06588 Rolig nu Stinker... Manden bliver jo nok ikke betalt mere end et par mio om året for at være ekspert på GEN og et par andre aktier (i andre brancher), hvis man kender Jyske ret..... ;)
Nu skal vi lige annoncerer de milestones, som jeg synes ligger omkring det forventelige hvis de er 50 mill. dollar. Hvis vi ryger op på 75 mill. dollar mener jeg det er bedre end hvad vi har forventet.
1/4 2009 13:54 Solsen 06598 Med mindre GSK vælger at tage den store pung frem nu så tror jeg at Genmab er en død fugl i de næste par måneder.
Absolut ingen nyheder er ventet.
Men når vi nærmer os FDAs afgørelse må der være nogen der vil tanke op.
Absolut ingen nyheder er ventet.
Men når vi nærmer os FDAs afgørelse må der være nogen der vil tanke op.
Vi er vel enige om at Milestones er på trapperne, ikke!
"En død fugl" pas på med metaforikken. Kan vi ikke kalde det "en sovende elefant"?
"En død fugl" pas på med metaforikken. Kan vi ikke kalde det "en sovende elefant"?
1/4 2009 14:33 Solsen 06608 Jo sikkert inden ugen er omme.
Men betaler GSK 50-100 mio USD i milestones så byder de ikke på Genmab før godkendelse af ofatumumab.
Peaker Genmab nu sælger mange, idet der er rig lejlighed til at komme på vognen senere.
Men betaler GSK 50-100 mio USD i milestones så byder de ikke på Genmab før godkendelse af ofatumumab.
Peaker Genmab nu sælger mange, idet der er rig lejlighed til at komme på vognen senere.
1/4 2009 20:35 Solsen 06657 Genmab har super-avastin i pipelinen.....desværre mange år forude 
Roche får noget for pengene ( men jeg sysnes stadig at avastin er en giftig sag !
U.S. panel sees brain cancer benefit with Roche drug
Tue Mar 31, 2009 4:25pm EDT Email | Print | Share| Reprints | Single Page[-] Text [+]
By Susan Heavey
WASHINGTON (Reuters) - Early data for Roche Holding AG's drug Avastin shows enough promise in treating patients with a certain brain cancer to be considered for quick approval, a U.S. advisory panel said on Tuesday.
The drugmaker is seeking accelerated approval to market the drug for patients diagnosed with a recurrence of the particularly deadly disease after trying other therapies first. The drug, made by its recently acquired Genentech unit, is already used to treat lung, colon and breast cancers.
Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in size to warrant faster approval before the company finishes a larger trial to confirm the benefit, the panel said in a 10-0 vote.
"I think these results are dramatic," said panel member Jay Loeffler, head of radiation oncology at Massachusetts General Hospital in Boston.
Many panelists also said they were optimistic that the company's larger, long-term trial would confirm Avastin's benefits for patients with glioblastoma multiforme, an especially fatal tumor.
Company officials said the trial, which would target newly diagnosed patients, would begin enrolling patients soon and would have full results in 2014. Meanwhile, earlier data looked promising enough to help patients now, especially with few other treatments available.
"We're confident that we have met the criteria for accelerated approval," said David Schenkein, senior vice president for cancer products at Genentech, which saw U.S. net sales of $2.7 billion from Avastin in 2008.
Glioblastoma has seen renewed public attention since Senator Edward Kennedy was diagnosed with the malignant tumor last year. It is one of the deadliest types of cancer, with patients surviving six to 12 months after diagnosis on average, or six months without treatment.
About 10,000 patients are diagnosed with the disease each year, Genentech said citing the American Cancer Society.
At the meeting, cancer advocates cheered the panel's vote after more than a dozen testified in support of approval.
Avastin patient Gail McWilliams, who lived several years after her diagnosis, said the injectable drug "was a blessing to me ... I feel like the luckiest person on earth."
While the FDA does not weigh costs when approving products, many insurers decide whether to pay for certain uses of medication based on FDA clearance.
Genentech spokeswoman Kristina Becker said the estimated cost for a course of Avastin for brain cancer would be $39,600, adding that programs are available to help with costs.
http://www.reuters.com/article/healthNew...
Roche får noget for pengene ( men jeg sysnes stadig at avastin er en giftig sag !
U.S. panel sees brain cancer benefit with Roche drug
Tue Mar 31, 2009 4:25pm EDT Email | Print | Share| Reprints | Single Page[-] Text [+]
By Susan Heavey
WASHINGTON (Reuters) - Early data for Roche Holding AG's drug Avastin shows enough promise in treating patients with a certain brain cancer to be considered for quick approval, a U.S. advisory panel said on Tuesday.
The drugmaker is seeking accelerated approval to market the drug for patients diagnosed with a recurrence of the particularly deadly disease after trying other therapies first. The drug, made by its recently acquired Genentech unit, is already used to treat lung, colon and breast cancers.
Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in size to warrant faster approval before the company finishes a larger trial to confirm the benefit, the panel said in a 10-0 vote.
"I think these results are dramatic," said panel member Jay Loeffler, head of radiation oncology at Massachusetts General Hospital in Boston.
Many panelists also said they were optimistic that the company's larger, long-term trial would confirm Avastin's benefits for patients with glioblastoma multiforme, an especially fatal tumor.
Company officials said the trial, which would target newly diagnosed patients, would begin enrolling patients soon and would have full results in 2014. Meanwhile, earlier data looked promising enough to help patients now, especially with few other treatments available.
"We're confident that we have met the criteria for accelerated approval," said David Schenkein, senior vice president for cancer products at Genentech, which saw U.S. net sales of $2.7 billion from Avastin in 2008.
Glioblastoma has seen renewed public attention since Senator Edward Kennedy was diagnosed with the malignant tumor last year. It is one of the deadliest types of cancer, with patients surviving six to 12 months after diagnosis on average, or six months without treatment.
About 10,000 patients are diagnosed with the disease each year, Genentech said citing the American Cancer Society.
At the meeting, cancer advocates cheered the panel's vote after more than a dozen testified in support of approval.
Avastin patient Gail McWilliams, who lived several years after her diagnosis, said the injectable drug "was a blessing to me ... I feel like the luckiest person on earth."
While the FDA does not weigh costs when approving products, many insurers decide whether to pay for certain uses of medication based on FDA clearance.
Genentech spokeswoman Kristina Becker said the estimated cost for a course of Avastin for brain cancer would be $39,600, adding that programs are available to help with costs.
http://www.reuters.com/article/healthNew...
1/4 2009 20:38 Solsen 06658 Lidt inden forboldkampen ... PDLI-plant
http://www.genmab.com/Manufacturing.aspx
http://www.genmab.com/Manufacturing.aspx
1/4 2009 21:22 Solsen 06661 http://seekingalpha.com/article/128914-genentech-seals-roche-s-dominance-of-oncology-market?source=article_lb_articles
Roche/Genentech dominerende på cancerområdet
GSK ville med kontrol over Genmab kunne bide dem i haserne om nogle år
Roche/Genentech dominerende på cancerområdet
GSK ville med kontrol over Genmab kunne bide dem i haserne om nogle år
