Amgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End PointsAmgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End Points
Teasing with top-line results, the company says the PCSK9 inhibitor dropped LDL-C vs ezetimibe at 24 weeks in patients intolerant of statins, similar to what was shown in the 12-week GAUSS-2 trial. Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 5, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news
Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol
Study Meets Co-Primary Endpoints of LDL Cholesterol Reduction
THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The mean percent reductions in LDL-C, or "bad" cholesterol, c...
Source: Amgen News Release - February 4, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Impax Receives Tentative FDA Approval for Generic Version of Vytorin(R) (ezetimibe and simvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
HAYWARD, Calif., Feb. 2, 2016 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (IPXL) today announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application... Biopharmaceuticals, Generic, FDAImpax Laboratories, ezetimibe, simvastatin, Vytorin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 2, 2016 Category: Pharmaceuticals Source Type: news
ezetimibe, Zetia
Title: ezetimibe, ZetiaCategory: MedicationsCreated: 2/5/2003 12:00:00 AMLast Editorial Review: 12/22/2015 12:00:00 AM (Source: MedicineNet Cholesterol General)
Source: MedicineNet Cholesterol General - December 22, 2015 Category: Cardiology Source Type: news
Dec 18 Cardiology NewsDec 18 Cardiology News
Ezetimibe, bioresorbable stents, guideline adherence, cardiac rehab, ABIM concessions, and end-of-year reviews are covered in this week's podcast. theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 18, 2015 Category: Cardiology Tags: Cardiology News Source Type: news
Merck's Vytorin Study Epitomizes Inherent Risks Of Major Clinical Trials
But, as Merck has taught us with IMPROVE-IT, CVOTs are risky and success is not a given. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 16, 2015 Category: Pharmaceuticals Authors: John LaMattina Source Type: news
CardioBrief: FDA Panel Rejects Broader Ezetimibe Indication
(MedPage Today) -- Majority finds event reduction in IMPROVE-IT too small to justify label change (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - December 15, 2015 Category: Primary Care Source Type: news
FDA Advisors: Reject Secondary-Prevention Ezetimibe IndicationFDA Advisors: Reject Secondary-Prevention Ezetimibe Indication
UPDATED // Noting that the secondary-prevention IMPROVE-IT trial's results weren't "clinically substantial," the panel also voiced concerns with hemorrhagic stroke risk and missing study data. Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 15, 2015 Category: Cardiology Tags: Cardiology News Source Type: news
FDA Panel Won't Back Broader Use of Merck's Cholesterol Meds
Merck can not claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, concluded an FDA advisory panel. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 15, 2015 Category: Pharmaceuticals Source Type: news
Merck fails to win FDA panel backing for Vytorin heart claim
(Reuters) - Merck & Co should not be allowed to claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday. (Source: Reuters: Health)
Source: Reuters: Health - December 15, 2015 Category: Consumer Health News Tags: healthNews Source Type: news
Merck Statement on FDA Advisory Committee Meeting on IMPROVE-IT Study with VYTORIN® (ezetimibe and simvastatin)
Dateline City:
KENILWORTH, N.J.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, issued today the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.
Language:
Engl...
Source: Merck.com - Corporate News - December 14, 2015 Category: Pharmaceuticals Tags: Corporate News Latest News Source Type: news
FDA panel rejects Merck claim Zetia/Vytorin cut heart risk
(Reuters) - Merck & Co should not be allowed to claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday. (Source: Reuters: Health)
Source: Reuters: Health - December 14, 2015 Category: Consumer Health News Tags: healthNews Source Type: news
CardioBreak: FDA Looks at Ezetimibe, VTE Tx in Cancer
(MedPage Today) -- Recent developments of interest in cardiovascular medicine (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - December 14, 2015 Category: Geriatrics Source Type: news
FDA Takes Another Look at Ezetimibe
(MedPage Today) -- Live blog from Larry Husten (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 14, 2015 Category: American Health Source Type: news
