FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants

  Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…

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ROCKET AF Investigators Say New Analysis Supports Original Trial Results

–Test of stored blood may help answer troubling questions about the trial. A new analysis of stored blood by the ROCKET AF trial investigators may help resolve lingering questions about the trial. The questions about ROCKET AF, which compared rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation, emerged last November, when…

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New Studies Seek To Allay Concerns Over The ROCKET-AF Trial

New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…

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Precision Medicine, Stuck In Second Grade, Flunks Test Of Clinical Utility

One of the great scientific achievements of the past generation has been the identification and characterization of the genetic underpinnings for many diseases. By combining genetic information with other forms of research doctors have been able to reach a much deeper understanding of many diseases. In a few cases genetic information has proved useful in screening…

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New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf

(Updated) 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…

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CMS Proposal Would Plug Up Watchman Reimbursement

Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…

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Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding

A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…

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New York Times: Indiana Cardiologist Accused Of Performing Unnecessary Procedures

Just when you thought it was safe to read the paper again, along comes a New York Times report suggesting that not all cardiologists have learned the seemingly obvious lessons from the overuse scandals from the past decade. In a front page article in Sunday’s business section, Julie Creswell writes about the ongoing controversy and scandal involving cardiologist Arvind Gandhi,…

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DOJ May Soon Announce Settlements With Hundreds Of Hospitals Over ICD Overuse

The US Department of Justice may be getting ready to announce that hundreds of hospitals have settled with the government in response to a lengthy investigation over ICD (implantable cardioverter defibrillator) overuse, according to an article by Lisa Schencker in Modern Healthcare. “The U.S. Justice Department may announce in the coming weeks what may be the largest False Claims Act…

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200-Year-Old Heart Drug Linked To Increased Risk Of Death

For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin.  Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there…

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FDA Approves Amgen Heart Failure Drug

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan. Ivabradine was approved for the reduction of hospitalization from worsening heart failure. … Click here to read the full post on Forbes.    …

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Gilead’s Hepatitis Drugs Tripped By Old Heart Drug

Late last week Gilead Sciences issued a warning about a rare but potentially fatal interaction between its stellar new hepatitis C drug sofosbuvir and amiodarone, a potent but tricky antiarrhythmic agent. Sofosbuvir is marketed as Sovaldi and, in combination with another antiviral agent, as Harvoni. Amiodarone, which is used to treat dangerous heart rhythm problems, has a number of…

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What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…

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FDA Approves New Oral Anticoagulant From Daiichi Sankyo

And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace… … Click here to read the full post on Forbes, including a…

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Cardiology Drugs Of The Year: New, Old, And Not-So-Funny

New Drug Of The Year: LCZ696 from Novartis Old Drug of the Year: Ezetimibe Not-So-Funny Drug of the Year: Ivabradine … Click here to read the full post on Forbes.  …

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Study Suggests Epinephrine for Cardiac Arrest May Be Harmful

Epinephrine has been a cornerstone of therapy during cardiac resuscitation after cardiac arrest because of its well-established ability to stimulate the heart and increase the probability of a return of spontaneous circulation (ROSC). In recent years, however, concerns have been raised that people treated with epinephrine may have worse neurological outcomes following their resuscitation. In a…

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FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed. … Click here to read the full post on Forbes….

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Grad Student Invents Flying Ambulance Drone To Deliver Emergency Shocks

Drones have been used to kill people in war zones and to spy on people. Now a sharp young  graduate student in the Netherlands has come up with an innovative new use for drones that could one day help save thousands of lives. Click here to read the full post on Forbes. [youtubevid id=”y-rEI4bezWc”]    …

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FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. … Click here…

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Novel Boston Scientific Device Headed For Another Rough FDA Panel

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than…

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Counterintuitive Advice About Staying Alive After A Heart Attack

… An interventional cardiologist– the cardiologists who put in stents and usually treat heart attack patients in the first few hours– asked an electrophysiologist– the cardiologists who treat arrhythmias– whether wearable defibrillators should be used post-MI. Here’s what that electrophysiologist, Edward J. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, replied….

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SIGNIFY Trial Provokes Sound And Fury Over Controversial Servier and Amgen Drug

The controversial drug ivabradine just got a little more controversial. The drug, which is marketed by Servier under the brand names of Corlentor and Procoralan, is available in Europe and elsewhere and is used for the treatment of heart failure and stable angina. The drug is not available in the US, but it is under development by Amgen for a heart…

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Silencio! Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference

Investigators of the much-anticipated and controversial SIGNIFY trial have told the European Society of Cardiology leadership that they will not participate in a previously scheduled press conference on Sunday at the society’s main meeting in Barcelona. But they say they will present the main results of their trial at a Hot Line session later in the afternoon….

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Increased Heart Risk Linked To Popular Antibiotic

Acute use of the popular macrolide antibiotic clarithromycin has been linked to a small but significant increase in cardiac death. In a report in the BMJ, researchers in Denmark analyzed the effects over a 14-year period of the acute use of penicillin V, roxithromycin, and clarithromycin. Earlier research raised concerns that marcrolide antibiotics in general, and erythromycin and azithromycin in particular,…

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Study Offers Little Support for an Old Drug

Digoxin is one of the oldest drugs in the cardiovascular arsenal, derived from the foxglove plant and first described in the 18th century by William Withering. It is frequently used in patients with heart failure (HF) and with atrial fibrillation (AF). The few trials supporting its use were performed in HF patients before newer treatments…

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