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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...
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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...
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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...
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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...
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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...
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Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’...
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...
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FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In...
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...
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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...
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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...
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New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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....
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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....
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FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and...
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...
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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...
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Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard Luck...
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...
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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...
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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...
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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...
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