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  • DNDN

    Dendreon Corporation : Dendreon Announces Marketing Authorization for PROVENGE® in the European Union

    September 17, 2013 - Dendreon Corporation (Nasdaq: DNDN) today announced that the European Commission (EC) has granted marketing authorization for PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorization in the EU.

    The marketing authorization provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.…e-European-Unio-17273945/

    Erstaundlich dass der Kurs hier nicht stärker reagiert....?!:wacko:

    Niemand mehr dabei?

  • 2brix hat am 17.09.2013 - 21:38 folgendes geschrieben:

    Ich bin dabei.

    Der Kurs reagiert jetzt noch nicht stärker weil DNDN zwei Probleme hat:

    1. Mehr als 50 Mio Shorts was mehr als 1/3 ist!!!

    2. DNDN braucht Geld

  • b00n hat am 23.08.2013 - 21:24 folgendes geschrieben:

    BELLUS Health Inc : Pharma Boardroom interview with Bellus CEO Roberto Bellini


    Bellus Health's primary pharmaceutical candidate, Kiacta, is in phase III clinical trials. What is this compound's latest development?

    Kiacta is Bellus' most advanced and important product, which is currently in the last stage of testing, phase III. It is for a rare disease, AA amyloidosis, which affects the kidneys of 30,000 to 50,000 patients in United States, Europe and Japan. AA amyloidosis patients' kidney functions deteriorate quite rapidly from diagnosis and within 10 years, most are on dialysis or dead. Kiacta binds the amyloid inhibiting it from forming toxic fibrils and plaques that clog the kidneys. Bellus' phase II/III study demonstrated a 42 percent risk reduction in kidney damage for patients on Kiacta. The potential market size is approximately half a billion dollars per year in peak sales.

    Bellus has agreements with the FDA and EMEA to run a confirmatory phase III study, which is currently on-going. If this study generates similar results to the first study, Kiacta will receive approval.


    Bellus put a partnership in place with an American private equity group called Auven Therapeutics to finance the phase III confirmatory study of Kiacta. This group gave Bellus a $10 million upfront payment, and made a commitment of $50 million for the phase III study of Kiacta. After speaking to the FDA, the design for the Kiacta phase III study was done in-house and the actual execution is being done by a CRO. This overall strategy allowed Bellus Health to reduce its size to ten employees. The burn rate has been reduced considerably as well, from $2 million per month to less than $300,000 per month



    geht da echt noch mehr?



    +0.64 (21.19%)…=en&ei=MmNAUoDtL8itwAPQBw

    Cardiome Announces Publication Of Positive Data From A Study Comparing Vernakalant IV Versus Propafenone And Flecainide

    VANCOUVER, Sept. 23, 2013 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced publication of positive data from an open label study in patients with atrial fibrillation that compared treatment with vernakalant intravenous (IV) to oral propafenone and oral flecainide. Patients treated with vernakalant achieved conversion to normal sinus rhythm in a median time of 12 minutes compared to 151 minutes for the propafenone group and 162 minutes for the flecainide group (p<0.01). These results appeared in the current issue of the Journal of Atrial Fibrillation, a peer reviewed medical journal, and represents the first study to compare these three agents.

    "I am pleased that the favorable results of this study show that in patients with recent onset atrial fibrillation, treatment with vernakalant IV was associated with more rapid conversion to normal sinus rhythm than propafenone or flecainide, both of which are frequently prescribed antiarrhythmic medications," stated William Hunter, M.D., Chief Executive Officer of Cardiome Pharma Corp. "The faster conversion rate with intravenous vernakalant experienced at this center translated to shorter length of stay in the emergency room compared to the other two therapies and we believe these results can be replicated across other centers worldwide in similar patient groups."

    "Vernakalant IV, with its fast onset of action, is a well-tolerated and effective alternative to propafenone or flecainide in this patient population," stated Diego Conde, M.D., Chief of Cardiovascular Emergency Care Section, Instituto Cardiovascular de Buenos Aires. "The significant advantage in time to conversion to normal sinus rhythm with vernakalant compared to propafenone or flecainide, that leads to a reduction in hospital stay-length may result in patient benefits," Dr. Conde added.

    Patients with symptomatic recent onset atrial fibrillation (less than 48 hours duration) without structural heart disease or hemodynamic instability were eligible for the study. Subjects received a single oral dose of 600 mg of propafenone (N=50), a single oral dose of 300 mg of flecainide (N=50), or vernakalant IV (N=50) in an initial dose of 3.0 mg/kg for 10 minutes and an additional 2 mg/kg if atrial fibrillation had not resolved within 15 minutes. The conversion rate approximated 80% in both the propafenone and flecainide groups at 8 hours versus 90% in the vernakalant group at 2 hours. This difference was not statistically significant at 8 hours. In addition to the more rapid time to cardioversion, patients treated with vernakalant IV experienced a significantly shorter median hospital length of stay, 243 minutes (interquartile range [IQR], 190-276) versus 422 minutes (IQR, 341- 739) for the patients treated with propafenone and 410 minutes (IQR, 330-727) for the patients treated with flecainide (p<0.01). No adverse events were reported.…ropafenone-and-flecainide

  • Ich hoffe doch schwer das CRME noch Fett hoch zieht... die sind ja ohne News langsam von der 2$ Marke hoch gezogen. Jetzt bei solchen News hätte ich eigentlich eine Explosion erwartet so wie die Amis sind springen die Titel meist um die 100% hoch. Ich bleib noch sicher bis Morgen drin und beobachte den verlauf. MfG Nedoli

    Wünsche jedem nur das Beste..!!!

  • Nedoli hat am 23.09.2013 - 19:53 folgendes geschrieben:


    Ich hoffe doch schwer das CRME noch Fett hoch zieht... die sind ja ohne News langsam von der 2$ Marke hoch gezogen. Jetzt bei solchen News hätte ich eigentlich eine Explosion erwartet so wie die Amis sind springen die Titel meist um die 100% hoch.
    Ich bleib noch sicher bis Morgen drin und beobachte den verlauf.
    MfG Nedoli

    erstaunt mich also auch, dass sie nun wieder abverkauft werden. Wenn das so weiter geht, ist sie bald beim Eröffnungskurs.

    • Vortag 3.02
    • Eröffnung 3.19
    • Höchst 4.05
    • Tiefst 3.17

    vor allem wenn man das sieht

    • Hoch J 4.05 23.09.2013
    • Hoch VJ 13.45 03.01.2012
  • Wenn ich mir den Jahres Chart von CLDX anschaue wird es mir ganz schwindlig

    Unglaubliche Performance Rindopepimut könnte ein Blockbuster werden Avastin hier kein Überlebensvorteil zeigen können so dass Rindopepimut zur ersten Wahl werden könnte :)

    Out ACUR 1.84 $ hab heute keine Nerven GNVC lässt grüssen...

  • Einfach nicht vergessen CLDX hat bis jetzt noch keinen Cent verdient und verbrennt nur jede Menge Cash von den vielen Kapitalerhöhungen in den vergangenen Jahren !

    Der aktuelle Kurs (fast 3 Mrd Marktkapital) ist eigentlich nur Fantasie der Anleger Investoren u Analysten u der Weg ist sehr steinig bis das def Ok von der FDA durchkommt Aber die Pipeline von CLDX ist echt stark aufgestellt u *könnte* X Milliarden Dollar Wert sein :)

    Ja das wäre ein Ding...besser als Avastin dann hätte Roche echt ein Problem u wäre nur noch zweite Wahl ;)