Bausch Health ehemals VALEANT PHARMA Allergan-Übernahme beflügelt (Seite 282)

[marty44]

Valeant Pharmaceuticals-Aktie: Skepsis ist angebracht, aber die Lage hat sich gebessert! - Aktienanalyse

http://www.aktiencheck.de/exklusiv/Marktberichte-Valeant_Pha…

[billforus]

Wir müssen uns bei Valeant bewusst sein, dass wir hier einen Marathon vor uns haben. Kurzfristig ist der Kurs nicht kalkulierbar. Die Sanierung des Unternehmens braucht Zeit.

Gestern schrieb ein Anleger im amerikanischen Forum, dass er nach den beiden letzten Börsentagen um $13,50 die Geduld mit Valeant verliert und nun verkauft. Joe Papa müsse endlich weitere Verkäufe melden, damit der Kurs endlich steigt.

Der Kurs ist in den letzten 4 Wochen 50% gestiegen und darf auch mal moderat zurücklaufen.

[marty44]

https://fintel.io/so/us/vrx

Morgan Stanley hat auch noch mal nachgelegt.
Also verkauft ruhig, die wollen bestimmt ihr Geld vernichten.

[marty44]

Bausch + Lomb Introduces renu® Advanced Formula Multi-Purpose Solution

http://ih.advfn.com/p.php?pid=nmona&article=74661706&symbol=…

[marty44]

BRIEF-EyeGate receives milestone payment from Valeant

http://www.reuters.com/article/brief-eyegate-receives-milest…

[marty44]

Valeant Pharmaceuticals International (VRX) Bank of America Merrill Lynch 2017 Health Care Conference - Slideshow
https://seekingalpha.com/article/4075282-valeant-pharmaceuti…

[X-Remi]

EMA committee recommends approval of LEO Pharma's brodalumab to treat adult patients with moderate-to-severe plaque psoriasis
United Kingdom
Monday, May 22, 2017, 15:00 Hrs [IST]

AstraZeneca has announced that its partner LEO Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of brodalumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Brodalumab is the first and only fully human monoclonal antibody that selectively targets the IL-17 receptor. By binding to the receptor, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis, a chronic, debilitating skin disease that causes red patches of skin covered with silvery scales.

In July 2016, AstraZeneca announced an agreement granting LEO Pharma, a specialist in dermatology, exclusive rights to develop and commercialise brodalumab in Europe. Today’s announcement follows the approval of brodalumab by the US Food and Drug Administration (FDA) (brand name Siliq) in February 2017 and the approval by the Japanese Pharmaceuticals and Medical Devices Agency, in 2016.

The CHMP’s positive opinion on brodalumab will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). The final decision is applicable to all EU and European Economic Area countries (Iceland, Liechtenstein and Norway).

Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

The CHMP positive opinion is based on data from the three AMAGINE Phase III pivotal studies that demonstrated that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis with approximately twice as many patients on brodalumab achieving total skin clearance compared to ustekinumab at week 12 in two replicate comparator trials involving over 2,400 patients.

LEO Pharma has exclusive rights to develop and commercialise brodalumab in Europe.

Valeant Pharmaceuticals has the global exclusive licence to develop and commercialise brodalumab, except in Europe, Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd through an agreement with Amgen.

[X-Remi]

ich verstehe es nicht und weiß es auch nicht, was hat LEO zu der Zulassung von Brodalumab beigetragen..wenn Valeant die ganze arbeit geleistet hat und die EMA hat die Zulassung aus der FDA-Zulassung übernommen..Valeant soll bestimmt auch an LEO verkäufe verdienen

[marty44]

Mylan wins challenge to Valeant Apriso patent, shares up a fraction, VRX down 1%

https://seekingalpha.com/news/3268806-mylan-wins-challenge-v…



Kenne ich nicht, kann ich vom Impact nicht einschätzen.

[marty44]

No meaningful association between suicidal behavior and the use of IL-17A-neutralizing or IL-17RA-blocking agents.
https://www.ncbi.nlm.nih.gov/pubmed/27554637



Indeed, a careful re-evaluation of brodalumab safety profile is being performed and no evidence clarified a significant association or a pathogenic mechanism linking brodalumab treatment to the risk of suicidal behavior, suggesting that cases of suicidal behavior accidentally occurred during brodalumab trials.

Das klingt nach der wissenschaftlichen Vorstufe von einem Freispruch von Suizidrisiko ausgelöst durch Brodalumab. Schätze nach einer Laufzeit nach Markteinführung, unterstützt durch diesen Artikel - kann dann ein Antrag auf Labeländerung/ -erleichterung bei FDA erfolgen.