Farmas USA

yo hasta el proximo año no la toco ... 

NVAX

Amarin Announces REDUCE-IT Cardiovascular Outcomes Study Final Patient Visits to Commence in March 2018

On-Track to Report Clinical Results for this Potential Landmark Study Before the End of Q3 2018

BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 19, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health,  today announced REDUCE-IT cardiovascular outcomes study clinical sites have been instructed to begin scheduling patients for final study visits commencing March 1, 2018.  Amarin confirmed it is on track to report top-line results from the first of its kind, potentially landmark, REDUCE-IT cardiovascular outcomes study before the end of Q3 2018.  Amarin maintains its guidance that the onset of the targeted 1,612th primary major adverse cardiovascular event (MACE) in this study is projected to occur before the end of Q1 2018.

Amarin is excited that this important study of over 8,000 patients, which began in 2011, is nearing conclusion. The company looks forward to learning and reporting the results of this first ever prospective study of drug therapy to lower cardiovascular risk in patients who, despite controlled LDL-cholesterol, have elevated triglyceride levels and other cardiovascular risk factors. The REDUCE-IT study is being conducted at over 400 clinical sites in 11 countries. To facilitate a timely study wrap-up, Amarin has informed clinical sites that study completion is close at hand, and that they should begin to schedule patients for their final patient visit. During on-site final patient visits, clinical sites will confirm vital status, take a lipid panel and other blood measures, and complete each patient's physical examination and updated medical history record including any potential clinical events. This final patient visit process is consistent with prior cardiovascular outcomes studies for other drugs evaluating other indications for use, and consistent with the study design of the REDUCE-IT trial, which is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

"Scheduling final patient visits is an important step toward completion of the REDUCE-IT study," commented Dr. Steven Ketchum, Amarin senior vice president, president of R&D, and chief scientific officer.  "We are very appreciative of the continued dedication of patients and clinical sites in this study.  We believe the results of this study will provide valuable clinical and scientific information about the potential outcomes benefit of Vascepa and lead to better informed preventative care of patients at high cardiovascular risk. The results of recent real-world evidence studies presented at the annual scientific sessions of the American Heart Association in November 2017 provide us further evidence of the increased cardiovascular risk in patients with elevated triglyceride levels and optimism for the potential impact of the first of its kind REDUCE-IT study."   

Amarin is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is completed and the database is locked. Final patient visits will be followed by adjudication of all newly reported cardiovascular events in the study, completing data entry for the now greater than 30,000 patient years of study in REDUCE-IT, and typical database quality control measures, known as cleaning.  This will be followed by database lock and final efficacy and safety analyses, including analysis of the trial's primary endpoint of first MACE events in the study and the more than thirty pre-defined secondary and tertiary endpoints. Publication of the study design can be found at  https://doi.org/10.1002/clc.22692.  The lead author of this paper published in Clinical Cardiology was Deepak L. Bhatt, M.D., M.P.H., executive director of the Interventional Cardiovascular Programs at Brigham and Women's Hospital, professor of medicine, Harvard Medical School in Boston, Mass.

The timing of the announcement of the March 1, 2018 commencement of final patient visits in the REDUCE-IT study reflects projections of the onset of the targeted 1,612th primary MACE, and the practical reality that it requires time to effectively schedule thousands of patients in multiple countries to visit clinical sites in an orderly and timely manner.  The estimate of timing of the onset of the 1,612th MACE event is based on actual adjudicated events from inception to date in the study. The projection of the number of MACE events that will ultimately be adjudicated as a primary event (first event for the patient within the duration of the study) is also based on historical data of adjudicated events within the REDUCE-IT study. Such projections are made by independent statisticians and reviewed by Amarin and the independent steering committee for the trial, all of whom are blinded. The study was designed to provide sufficient power to detect the anticipated result, regardless of whether the final number of primary MACE is slightly more or slightly fewer than 1,612 primary MACE.

Nuevo CEO En SGYP!
APPOINTS TROY HAMILTON CHIEF EXECUTIVE OFFICER

DECEMBER 19, 2017
Co-Founder Gary S. Jacob, Ph.D., Named Executive Chairman

NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced that Troy Hamilton, Pharm.D., previously Executive Vice President, Chief Commercial Officer, has been appointed Chief Executive Officer, effective immediately. Gary S. Jacob, Ph.D., previously President, CEO and Chairman, has assumed the position of Executive Chairman of the Board of Directors.

MDGL

La colocación, a 83 y se le va sentando bien.

SGYP

Debería disparar  pues...

Edito: llevo solo media entrada. Querría cargar un poco más. Me he vuelto demasiado precavida.

Doblada posi en ACAD a 28,5 . Media 29,3

Añado mas KERX a 4,53. Media 4,79 

A ver si con estas medias salgo indemne de una p. vez

Lo he comentado en el hilo específico, pero lo repito aquí...

Me he salido de Novavax en $1.26, con lo que aún le he sacado algo más de mil maravedíes de pluses (llevaba 20k compradas en $1.18)... y ya la dejo quieta hasta el año que viene.

NVAX

KERX

Dentro tambien a 4.53

ACAD 1h