Amgen Denies Rumors About PCSK9 Inhibitors (Updated)
(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 20, 2015 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes People, Places & Events Policy & Ethics PCSK9 Amgen Sanofi Regeneron Repatha Praluent Source Type: blogs
Amgen Denies Rumors About PCSK9 Inhibitors
Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports of...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 20, 2015 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes People, Places & Events Policy & Ethics PCSK9 Amgen Sanofi Regeneron Repatha Praluent Source Type: blogs
Prepublish or Perish? Making a Case for Medicine to Take a Cue from Basic Science
It’s time for clinical research to join other scientific fields like physics and computer science and encourage preprint publication of manuscripts on the internet, according to three top cardiologists writing in a Lancet comment. Since 1969 researchers have labored under the constraints of the Ingelfinger rule, in which “posting a paper, data, or key findings on the internet represented presubmission...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 17, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics journals publications preprints Source Type: blogs
FDA Panel Turns Down Expanded Indication For Ezetimibe
An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 15, 2015 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes People, Places & Events Policy & Ethics cholesterol ezetimibe vytorin Merck FDA advisory panel Zetia IMPROVE-IT Source Type: blogs
Live Blog: The FDA Advisory Panel On IMPROVE-IT
...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 14, 2015 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes People, Places & Events Policy & Ethics vytorin FDA Merck FDA advisory panel Zetia IMPROVE-IT live blog Source Type: blogs
Test Live Blog
...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 14, 2015 Category: Cardiology Authors: Larry Husten Tags: Uncategorized Source Type: blogs
ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 14, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics warfarin rivaroxaban Xarelto Califf ROCKET-AF INR Source Type: blogs
Pioneering Cardiologist George Diamond Dead At 74
George Diamond, a pioneering cardiologist at the Cedars-Sinai Medical Center in Los Angeles, died on Saturday at the age of 74 from complications related to colon cancer. Here are some reactions to news of his death from several of his long-time friends and colleagues at Cedars-Sinai. Sanjay Kaul: “I am deeply saddened at the loss...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 13, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events George Diamond Source Type: blogs
Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe
You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 10, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA advisory panel IMPROVE-IT statins vytorin Zetia Source Type: blogs
More Concerns Raised About Possible Risks Of New Heart Failure Drug
More safety concerns are being voiced about Entresto, the new, ballyhooed heart failure drug from Novartis. Fueling these concerns is a mix of speculation, worry about the FDA’s rapid approval of the drug, and a long-running feud between two leading heart failure researchers. The concerns, raised in a JAMA Viewpoint by heart failure expert, Arthur Feldman, and co-authors Julia Haller and Steven...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 8, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Policy & Ethics Uncategorized Entresto LCZ macular degeneration neprilysin neurocognitive sacubitril Source Type: blogs
Survey: Docs Think Cardiologists Are Rude, Dismissive, And Aggressive
Nearly a third of English doctors report that they are subject to rude, dismissive and aggressive (RDA) behavior more than once a week. Cardiologists are among the specialists who are most likely to be responsible for this “workplace incivility.” These are some of the chief findings of a survey published in Clinical Medicine of 606 British doctors at three...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 7, 2015 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics bad behavior cardiologists rude survey Source Type: blogs
Prominent European Cardiologists Decry Curbs On Industry Support For Docs Attending Medical Meetings
Starting in 2018 European device companies will no longer be allowed to directly sponsor physician attendance at medical meetings. In response, three prominent European interventional cardiologists warn that the change could have dire consequences, stifling education and potentially reducing attendance at European medical meetings by 30-50%. In the US physicians can still enjoy free meals. But,...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 3, 2015 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics conflict of interest Europe meetings Source Type: blogs
PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years
Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 2, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Prevention, Epidemiology & Outcomes Entresto LCZ 696 life expectancy long term use PARADIGM Source Type: blogs
New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf
Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the trial...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - December 1, 2015 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Policy & Ethics Califf EMA FDA rivaroxaban warfarin Xarelto Source Type: blogs
Encouraging Results Found In Long Term TAVR Registry
Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - November 30, 2015 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Policy & Ethics CMS CoreValve Sapien TAVR TVT Registry Source Type: blogs
