Galapagos maart 2019

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VP 1958
0
quote:

Al Kipone schreef op 11 maart 2019 18:53:


[...]
Binnenkort specificeren ze de 'H2' en 'Q1' wel nader tot 'medio 2019'
Dan springen er van dit forum een paar van de brug.
BLOO7
1
1 week ago
GILEAD
Voor RA hebben ze al genoeg directors en managers voor filgotinib

Men schakelt een versnelling hoger
Director, Therapeutic Area Communications, Inflammation
www.linkedin.com/jobs/view/director-t...
Developing and implementing the product launch communications plan for Filgotinib
[verwijderd]
0
Raar op alle biotech fora worden de koersverwachtingen gemeten aan de open vacatures tegenwoordig :-)
asjemenou
0
Takeda's Entyvio beats AbbVie's Humira in head-to-head UC study
AUTHOR
Andrew Dunn
@AndrewE_Dunn
PUBLISHED
March 11, 2019

Dive Brief:
Takeda's Entyvio outperformed AbbVie's Humira as an ulcerative colitis therapy, according a topline readout of a Phase 3b study by the Japanese pharma.
The trial randomly assigned to each biologic 769 patients who had an inadequate response to previous treatment. After a year, the Entyvio arm posted a clinical remission rate of 31% compared to Humira's 23%, hitting statistical significance on the trial's primary goal.
On two secondary endpoints, Entyvio showed a higher rate of mucosal healing but AbbVie's therapy showed a numerical edge in the percentage of patients who achieved corticosteroid-free clinical remission, Takeda conceded. Data were presented Saturday in Denmark at the 14th Congress of the European Crohn's and Colitis Organization.




Dive Insight:
Earning an industry-leading $19.9 billion in sales last year, AbbVie's Humira (adalimumab) has long been a target. Competitors have targeted the drug clinically through head-to-head studies, but legal and politically as well. So far, the company has staved off U.S. biosimilar entry until 2023, but has been less successful in dodging scrutiny of its pricing and patent practices.

In the clinic, Humira has been pitted in head-to-head studies against other drugs before. While Pfizer's Xeljanz (tofacitinib) ?failed to achieve non-inferiority to the drug in rheumatoid arthritis two years ago, Eli Lilly's Taltz (ixekizumab) beat the anti-TNF biologic in active psoriatic arthritis last December.

Now, Takeda's trial is the first clinical study to directly compare two biologics in ulcerative colitis, or UC, said Jeff Bornstein, the company's executive medical director, in a March 9 statement.

"This is also the first time we have seen a direct comparison between two medicines with distinct modes of action in ulcerative colitis, the gut-selective anti-alpha4beta7 integrin vedolizumab and the anti-TNFa adalimumab," Bornstein said.

While the study was powered to measure efficacy, Entyvio (vedolizumab?) showed lower rates for adverse events (63% to Humira's 69%) and infections (34% to 44%), Takeda noted. The pharma's execs framed the study as demonstrating Entyvio's efficacy and safety compared to the market leader in inflammatory disease.

For Takeda, gastroenterology has been a key therapeutic area along with oncology, neuroscience and rare diseases. Entyvio is its top-selling gastro drug, posting roughly $1.8 billion in sales for the last nine months of 2018. (The Japanese pharma's current fiscal year began last April and runs through May 2019.)

Entyvio, an integrin receptor antagonist, is approved in the U.S. as a treatment for adults with UC or Crohn's disease. Humira's wide-ranging labels cover both those conditions, as well as rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis among others.
Föhn
0
quote:

Mopperaar schreef op 11 maart 2019 19:03:


[...]

Ja zenne, met bloed, zweet en tranen. Wel 3/5de verkocht 2 weken geleden om.me dikker te kunnen zetten in Galapagos. Never waste a good spike.

Maar t blijft natuurlijk altijd wat gokken. Ben jij eruit? Ik zie je daar niet meer.


Klopt.. ik heb winst genomen om vol in Gala te gaan. Wel een stuk van de rit omhoog gemist helaas. Hoop is nu gevestigd op dit mooie bedrijfje. Maar je hebt gelijk het blijft gokken
lmr
0
Zomaar twee feiten:
Sep 12, 2018 at 11:05 AM EDT
Gilead Sciences at the Morgan Stanley 16th Annual Global Healthcare Conference

September 11, 2018
Gilead and Galapagos Announce Filgotinib Meets Primary and All Key Secondary Endpoints in First Phase 3 Study in Rheumatoid Arthritis


Morgen is er ook een healthcare conference en we verwachten deze maand nog Finch resultaten....
robbie123
0
quote:

NielsjeB schreef op 11 maart 2019 18:05:


[...]
Huh? Heb je hier een letterlijke quote van?


Hallo NielsB

Hier de transcript text

Deze tekst is van 22 feb
Lees in de 2e alinea
End of this month dat is dan toch februari als dit op 22 februari wordt gezegd door hem



Of course, we are waiting with bated breath the results of our two Phase 3 trials, FINCH 1 and FINCH 3 which will be available by the end of this quarter. Those are in more than 2,600 patients and should help us better define the risk benefits profile there and see whether our working hypothesis is actually translating into reality impact by data.

Regarding the filing of 100 versus not. So, I've also spoken about this in a number of occasions. I'm very happy with the way we design our FINCH 3 program where we fully evaluate 100 and the 200-milligram in those studies. And at the end of the -- when we have all the package with all FINCH, again by the end of this month, we will be in a much better position to make an assessment on the risk benefit profile and whether we should file with both doses, one dose and so long so forth, but it's really premature at this point to do it.

If I may, however, extrapolate from the FINCH 2 data where we studied both doses in the biological incomplete responder, so those are the more difficult to treat patients. With those when you look at the data, both on efficacy and on safety what we see is you see a very good performance of 100-milligram very competitive, but we see also a better performance of 200, so there seem to be a dose responses in terms of efficacy. But what stood out also for us is the absence of any dose dependent uptick in adverse events or safety concern.

If this profile continue to be confirmed in the FINCH 1 and Finch 3 studies, then it will be in a very good place moving forward, but again, it's premature, we'll just wait -- we need to wait another -- few more weeks to be able to get the totality of the data, but that's where we are today

Toert
0
quote:

robbie123 schreef op 11 maart 2019 19:31:


[...]

Hallo NielsB

Hier de transcript text

Deze tekst is van 22 feb
Lees in de 2e alinea
End of this month dat is dan toch februari als dit op 22 februari wordt gezegd door hem



Of course, we are waiting with bated breath the results of our two Phase 3 trials, FINCH 1 and FINCH 3 which will be available by the end of this quarter. Those are in more than 2,600 patients and should help us better define the risk benefits profile there and see whether our working hypothesis is actually translating into reality impact by data.

Regarding the filing of 100 versus not. So, I've also spoken about this in a number of occasions. I'm very happy with the way we design our FINCH 3 program where we fully evaluate 100 and the 200-milligram in those studies. And at the end of the -- when we have all the package with all FINCH, again by the end of this month, we will be in a much better position to make an assessment on the risk benefit profile and whether we should file with both doses, one dose and so long so forth, but it's really premature at this point to do it.

If I may, however, extrapolate from the FINCH 2 data where we studied both doses in the biological incomplete responder, so those are the more difficult to treat patients. With those when you look at the data, both on efficacy and on safety what we see is you see a very good performance of 100-milligram very competitive, but we see also a better performance of 200, so there seem to be a dose responses in terms of efficacy. But what stood out also for us is the absence of any dose dependent uptick in adverse events or safety concern.

If this profile continue to be confirmed in the FINCH 1 and Finch 3 studies, then it will be in a very good place moving forward, but again, it's premature, we'll just wait -- we need to wait another -- few more weeks to be able to get the totality of the data, but that's where we are today




Je kan beter begrijpend lezen dan ikke. Ik was dus fout.
[verwijderd]
0
quote:

Toert schreef op 11 maart 2019 19:39:


[...]

Je kan beter begrijpend lezen dan ikke. Ik was dus fout.


Ik denk dat dit een verspreking was omdat hij 'again' gebruikt en ervoor over 'end of this quarter' had.
NielsjeB
1
quote:

robbie123 schreef op 11 maart 2019 19:31:


[...]

Hallo NielsB

Hier de transcript text

Deze tekst is van 22 feb
Lees in de 2e alinea
End of this month dat is dan toch februari als dit op 22 februari wordt gezegd door hem



Of course, we are waiting with bated breath the results of our two Phase 3 trials, FINCH 1 and FINCH 3 which will be available by the end of this quarter. Those are in more than 2,600 patients and should help us better define the risk benefits profile there and see whether our working hypothesis is actually translating into reality impact by data.

Regarding the filing of 100 versus not. So, I've also spoken about this in a number of occasions. I'm very happy with the way we design our FINCH 3 program where we fully evaluate 100 and the 200-milligram in those studies. And at the end of the -- when we have all the package with all FINCH, again by the end of this month, we will be in a much better position to make an assessment on the risk benefit profile and whether we should file with both doses, one dose and so long so forth, but it's really premature at this point to do it.

If I may, however, extrapolate from the FINCH 2 data where we studied both doses in the biological incomplete responder, so those are the more difficult to treat patients. With those when you look at the data, both on efficacy and on safety what we see is you see a very good performance of 100-milligram very competitive, but we see also a better performance of 200, so there seem to be a dose responses in terms of efficacy. But what stood out also for us is the absence of any dose dependent uptick in adverse events or safety concern.

If this profile continue to be confirmed in the FINCH 1 and Finch 3 studies, then it will be in a very good place moving forward, but again, it's premature, we'll just wait -- we need to wait another -- few more weeks to be able to get the totality of the data, but that's where we are today

Ik dacht inderdaad al dat dit de bron zou zijn. Walid maakte een verspreking. "by the end of this month" was geredeneerd vanuit maart, terwijl het nog februari was. Verderop in zijn verhaal heeft hij het consequent over "few more weeks" en "end of this quarter".

Als je de call even naluistert dan hoor je duidelijk de context waarin hij dit zegt.
Toert
0
quote:

Mopperaar schreef op 11 maart 2019 19:46:


[...]

Ik denk dat dit een verspreking was omdat hij 'again' gebruikt en ervoor over 'end of this quarter' had.


tis dus een moeilijk geval, dat begrijpend lezen.

in de rest van de tekst word er echter wel een keer of tien over "end of march/end of the quarter" gesproken.

Laat het ons op een akkoordje gooien : gewoon deze maand de resultaten, en we zijn allemaal content.
Fermín Romero de Torres
0
quote:

Endless schreef op 11 maart 2019 20:24:


Voor wat het waard is de Nasdaq is donker groen, deze week??
Volume is nog te magertjes. Er zijn altijd partijen die net iets meer weten. Als op een dag het volume hoger dan gemiddeld is, kun je er vergif op innemen dat de resultaten er aan komen. Misschien deze week :-)
Lang
0
quote:

Trikkie Dikkie schreef op 11 maart 2019 20:40:



Zomertijd: US sluit om 21.00.


waar ook, heb je gelijk in. dan is het volume wel erg laag daar.
jodu
0
is dit reeds gepost ?

finance.yahoo.com/news/3-top-biotech-...
... A win could net Galapagos up to $1.35 billion in milestones from Gilead Sciences, plus Galapagos can pocket royalties on U.S. sales ranging between 20% and 30%. In Europe, the companies will split profits equally. ... mooi mooi
Geert07
0
quote:

jodu schreef op 11 maart 2019 20:57:


is dit reeds gepost ?

finance.yahoo.com/news/3-top-biotech-...
... A win could net Galapagos up to $1.35 billion in milestones from Gilead Sciences, plus Galapagos can pocket royalties on U.S. sales ranging between 20% and 30%. In Europe, the companies will split profits equally. ... mooi mooi

Ja, en de milestone bedragen plus royalty percentages zijn allang bekend.
de tuinman
0
quote:

Geert07 schreef op 11 maart 2019 21:05:


[...]Ja, en de milestone bedragen plus royalty percentages zijn allang bekend.


Maar het is natuurlijk waar dat bij goede studieresultaten Galapagos enorme bedragen aan milestone bedragen gaat binnen harken.

Misschien niet direct, maar het komt wel.
Mippert
0
Beursupdate: AEX op Wall Street

(ABM FN-Dow Jones) Op Wall Street zijn maandag zes van de negen fondsen hoger gesloten ten opzichte van het slot in Amsterdam.

Aegon (+0,2%)
ArcelorMittal (+0,3%)
ASML (-0,1%)
Galapagos (+0,8%)
ING Groep (+0,4%)
Philips (-0,01%)
RELX (+0,7%)
Royal Dutch Shell (-0,2%)
Unilever (+0,5%)

Euro/dollar: 1,1248

Op basis van de bovenstaande koersuitslagen zou de AEX index, die sloot op 535,38 punten, zijn geëindigd op 536,07 punten.

Door: ABM Financial News.
Geert07
0
quote:

de tuinman schreef op 11 maart 2019 21:18:


[...]

Maar het is natuurlijk waar dat bij goede studieresultaten Galapagos enorme bedragen aan milestone bedragen gaat binnen harken.

Misschien niet direct, maar het komt wel.
De royalties zijn veel belangrijker dan de milestone betalingen, dat is waar het geld verdiend gaat worden. Plus de helft van de winst in Europa.
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