Farmas USA

TEVA Velas TRIMESTRALES

AMRN

A juzgar por el comportamiento del precio esta claro que ya lo sabia de antemano mas de uno ... que no iban a detener el estudio

Amarin's REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee

Landmark Cardiovascular Outcomes Study On-Track for Completion in 2018

BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the scheduled pre-specified interim efficacy and safety analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. Because REDUCE-IT is the first prospective clinical trial of any therapy in the large patient population studied, the bars for stopping this trial early for overwhelming efficacy were intentionally set high with the understanding that a more robust result, based on a larger number of cardiovascular events, could be obtained by the study continuing to completion. Results from the completed study are expected in Q2 or Q3 2018. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces major adverse cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.

In accordance with the study protocol, this interim efficacy analysis was performed after adjudication of approximately 80% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a final efficacy analysis will be triggered by the onset of approximately 100% of the target aggregate number of primary cardiovascular events. Amarin anticipates that the onset of approximately 100% of events will likely occur in early 2018. Amarin is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is stopped and the database is locked at the final analysis.

The DMC's recommendation to continue as planned also reflects its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in December 2011, and more than 30,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study.

The review and recommendation of the DMC at this interim look were made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC's closed session deliberation.

"We are pleased that we are nearing completion of the REDUCE-IT study and thank the independent DMC members for their diligence in overseeing this important study," said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. "This interim look provided important operational checks in preparation for study completion. We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of the existing and continually increasing body of data from clinical, epidemiologic, genetic, and real-world evidence studies, and we are preparing for the study conclusion."

Residual cardiovascular risk in statin-treated patients

Cardiovascular disease remains the leading cause of death in the United States, with the estimated costs of treating heart attacks, strokes and other cardiovascular disease manifestations exceeding $550 billion annually.¹ In the United States, about 40 million patients are treated with statins for the primary and secondary prevention of atherosclerotic cardiovascular events, including heart attacks and stroke.² Despite the demonstrated clinical benefits of lowering bad cholesterol (LDL-C) with statins, 60% to 75% residual cardiovascular risk remains for statin-treated patients.³ Vascepa is being studied in REDUCE-IT as an add-on to statin therapy in patients with persistent elevated triglycerides and other risk factors to further reduce cardiovascular risk, not as a replacement for statin therapy.

Estaba claro, milagros a Lourdes.

Sin embargo yo saco como muy positivo que sí con más del 80% el resultado es OK, al 100% también lo será y R-IT será exitoso, aunque no sea la pastilla de la juventud.

AMRN

REGN

Fail fase 3 RSV infantes y no continúan.

http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=1037184

Qué complicado es este virus...

sgyp

posible entrada 2.5x pero creo que estaba  mal de pasta y una dilución no la deja en 1.5 en nada.

Menuda subida lleva EDIT desde hace unos meses

Artículo divulgativo sobre CAR-T aparecido hace unos días en Time...

http://time.com/4895010/cancers-newest-miracle-cure

DVAX

Aparte de la compra de NVAX, he vendido las pocas que llevaba (+10%). Esperando que se aclare el panorama un poco.

Echando un ojo a RDUS, a promierdar VTGN para aprovechar el siguiente rebote (con miedo) y con tanto miedo que no me atrevo en SGYP XD.