Posts Tagged ‘FDA’

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May 12th, 2015

Diet Drug Study Crashes and Burns in the Wake of Leaked Results

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early […]


April 28th, 2015

Cardiovascular Outcomes with Sitagliptin: No Better or Worse Than Conventional Care

Late Monday afternoon, Merck released the top line results of TECOS, the cardiovascular outcomes trial with its diabetes drug sitagliptin (Januvia).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart […]


April 16th, 2015

FDA Approves New 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. It is indicated for use in stable heart-failure patients who are in sinus rhythm, have a resting […]


April 2nd, 2015

Liberal Changes to rt-PA Contraindications for Acute Ischemic Stroke

Dr. Craig Cocchio discussing changes to the contraindications for acute ischemic stroke, about which the FDA has been curiously silent.


March 24th, 2015

FDA Grants Premarket Approval to AbioMed Heart Pump

The FDA said on Tuesday that it had approved Abiomed’s Impella 2.5 System. According to the company, it is is the first hemodynamic support device to gain FDA approval for use during high risk PCI procedures. The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) […]


January 26th, 2015

Califf to Leave Duke to Become FDA Deputy Commissioner

The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.” […]


January 9th, 2015

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: dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). All four drugs were […]


January 5th, 2015

FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries

Medtronic said today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. The new DCB uses the anti-proliferative drug paclitaxel, […]


November 28th, 2014

FDA Approves New Noninvasive FFR Technology

The FDA said Wednesday that it had granted approval to a novel technology that noninvasively measures fractional flow reserve (FFR) using data obtained from a CT scan of the heart. In recent years a catheter-based form of FFR has been used by interventional cardiologists during catheterization procedures to measure the pressure gradient in partially blocked […]


November 19th, 2014

U.S. Proposal Would Greatly Expand Transparency of Clinical Trials

The U.S. Department of Health and Human Services today proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to report. “Medical advances would not be possible without participants in clinical trials,” said NIH Director Francis Collins. “We owe it to every participant and the public at large to […]