Re: Farmas USA
Hasta que alguien lo dice a veces no soy consciente de cuantos puede haber por ahi siguiendo nuestros aciertos y desaciertos .
:)
Hasta que alguien lo dice a veces no soy consciente de cuantos puede haber por ahi siguiendo nuestros aciertos y desaciertos .
:)
Un poco de cordura entre tanto articulo apestoso hoy.
Buenas noches
Proporcion diaria largos/cortos abiertos. Mirad la ultima sesion
AMRN
¿Alguno que siga TZYM qué ha subido ayer +25% sólo por una mejora de recomendación?
S2
Solrac,
Ahora mismo ZLCS esta muy mal....todo el retail esta vendiendo. Quedamos tu, yo y cuatro mas, pero yo panico no tengo. Este mismo año tiene catalizadores, yo si que la espero cercana a un dolar a final de año y tal y como estan las cosas ahora, casi que prefiero que el papel pase de manos retail a manos fuertes...
A corto plazo necesitamos que se renueve la alianza con Novartis.
http://www.zalicus.com/company/collaborators.asp#novartis
Saludos y animo !!
Achillion Announces Updated Phase 2 Results Including Early Sustained Virologic Response on ACH-3102 Plus Ribavirin in Genotype 1b Treatment-Naive Hepatitis C Patients
http://ir.achillion.com/releaseDetail.cfm?ReleaseID=758318
THIS IS GOOOOOOD!!
:)
Solicitud sNDA para ANCHOR : APROBADA.
Amarin Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia
Submission for Indication Studied in the ANCHOR Phase 3 Clinical Trial Under Special Protocol Assessment Agreement With FDA
BEDMINSTER, N.J. and DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Food and Drug Administration (FDA) has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and < 500 mg/dL) with mixed dyslipidemia. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.
"We are very pleased that the FDA has accepted our sNDA submission for the ANCHOR indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL and mixed dyslipidemia. We estimate that one in five, or nearly 40 million, U.S. adults have triglyceride levels ranging from 200 to 499 mg/dL," stated Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The ANCHOR study showed that Vascepa is unique in that it significantly lowered both triglycerides and LDL-cholesterol on top of optimized statin therapy and exhibited a safety and tolerability profile similar to placebo, unlike the clinical results of other triglyceride-lowering therapies. If approved for the ANCHOR indication, Vascepa will be the only approved prescription omega 3 therapy for cardiovascular health management in this patient population (TG ≥200 mg/dL and < 500 mg/dL with mixed dyslipidemia) and will represent the next generation of lipid management for potentially millions of patients."
http://investor.amarincorp.com/secfiling.cfm?filingid=1193125-13-165927