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ACC And STS Break New Ground To Test TAVR For Unapproved Uses
In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic...
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FDA Approves Second Generation MRI-Friendly Pacemaker System
Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which...
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FDA Issues Warning Letter To CoreValve Investigator
The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial...
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FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary...
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The PREVAIL Fail Revisited: Spinning The Truth
The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated...
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FDA Panel Gives Tepid Endorsement To Abbott’s MitraClip
The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. The panel met to evaluate use of the novel device in patients with...
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CHMP And FDA Diverge On Mipomersen And Rivaroxaban
The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA...
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Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The...
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FDA Approves First SGLT2 Inhibitor For Diabetes
The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors....
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FDA Schedules Another 2 Day Avandia Advisory Panel
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the...
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The FDA, Surrogate Endpoints, And Blood Pressure Drugs
In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the...
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Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal,...
Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. … Pradaxa label gains boxed warning. … Click here to read the...
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FDA Warns That Tolvaptan Can Lead To Serious Liver Injury
The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant...
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FDA Approves Combination Of Ezetimibe And Atorvastatin
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering...
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Encouraging 4 Year Results For Watchman Device In AF Patients
Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart...
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European Medicines Agency Starts Review of Combined Use Of Drugs That Block...
The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE...
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Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial...
Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the...
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Rivaroxaban Gains Approval In Europe For ACS Indication
Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome...
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Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are...
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Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers
Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal....
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