Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…

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FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific

The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the…

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Boston Scientific May Face A Tough FDA Panel

On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response…

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Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck Drug?

Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the…

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FDA Removes Restrictions On Avandia

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said…

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FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,”…

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No Evidence That Statins Impact Cognitive Function

In 2012 the FDA revised the label of statins to include a warning about reports that the drugs had been linked to memory loss or confusion. The FDA action appeared to be based largely on case reports. Despite concerns about this topic that have appeared sporadically in recent years, no high-quality review of the topic has appeared until now….

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No Evidence That Statins Impact Cognitive Function

In 2012 the FDA revised the label of statins to include a warning about reports that the drugs had been linked to memory loss or confusion. The FDA action appeared to be based largely on case reports. Despite concerns about this topic that have appeared sporadically in recent years, no high-quality review of the topic has appeared until now….

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The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT

Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…

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FDA Approves Abbot’s MitraClip For Patients At Prohibitive Surgical Risk

The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease. … Click here…

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FDA Approves First New Atherectomy Device In 20 Years

The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS  was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said  it would begin a controlled launch of the…

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FDA Approves New Pulmonary Hypertension Drug From Actelion

The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I). … Click here to read the full post on Forbes.  …

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First Leadless Pacemaker Gains Approval In Europe

St. Jude Medical announced on Monday that the world’s first leadless pacemaker had gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude…

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CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel

The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that…

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Cardiovascular Outcome Studies in Diabetes Drugs Finally Arrive

For many years critics have bemoaned the absence of outcome studies for the many diabetes drugs used to lower blood glucose levels. Now, finally, two large trials with different drugs have been presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in The New England Journal of Medicine. The good news is that…

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New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs

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Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized…

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FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH). Click here to read the full story on Forbes.        …

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FDA Warns That Popular Blood Pressure Drug Can Cause Severe Diarrhea

The FDA is warning that the widely-used antihypertensive agent olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added to…

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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to…

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Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the…

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Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9…

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Top Line Results: No Cardiovascular Benefits Found For Saxagliptin

Top line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the  annual meeting of the European Society of Cardiology in Amsterdam on…

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FDA Raises Concerns About The Cybersecurity Of Medical Devices

The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices.   … Halamka offered some additional perspective on the problem to the Washington Post: “There’s almost no medical…

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FDA Advisory Panel Backs Looser Restrictions On Avandia

After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions….

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With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial

  The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…

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