(Updated) On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data. Here is the Takeda statement: “Pursuant to the Collaboration Agreement between…
Orexigen Released Interim Data Without Approval Of Trial Leaders
March 3, 2015 by Leave a Comment
Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.) The surprising thing about the Orexigen disclosure, which was contained in a Form…
Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year
February 19, 2015 by Leave a Comment
Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their…
No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year
February 18, 2015 by Leave a Comment
In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case…. … Click here to read the full post on Forbes. …
Califf To Leave Duke To Become FDA Deputy Commissioner
January 26, 2015 by Leave a Comment
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…
Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race
January 26, 2015 by Leave a Comment
Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen. Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics…
FDA Approves New Oral Anticoagulant From Daiichi Sankyo
January 8, 2015 by 1 Comment
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…
FDA Approves New Noninvasive FFR Technology
November 26, 2014 by Leave a Comment
The FDA said today 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…. … Click here to read the full post on Forbes. …
US Proposal Would Greatly Expand Transparency Of Clinical Trials
November 19, 2014 by Leave a Comment
The US 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. … Click here to read the full post on Forbes. …
FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug
October 31, 2014 by Leave a Comment
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….
FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device
October 8, 2014 by Leave a Comment
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…
Novel Boston Scientific Device Headed For Another Rough FDA Panel
October 7, 2014 by Leave a Comment
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…
Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future
October 2, 2014 by Leave a Comment
Cholesterol drugs, both new and old, are in the news again. There’s a lot going on now but the picture won’t really become clear until next month, when the results of a decade-old trial will finally be revealed. Briefly, here’s what’s happening: Two new trials presented fresh evidence that PCSK9s, the much discussed new class of…
FDA Approves Lilly’s Once-Weekly Shot For Diabetes
September 18, 2014 by Leave a Comment
The FDA said today that it had approved dulaglutide, Lilly’s once-weekly injection to control blood sugar in adults with type 2 diabetes. The drug will be marketed under the brand name of Trulicity. … Click here to read the full post on Forbes. …
FDA Approves New Weight Loss Drug From Orexigen And Takeda
September 10, 2014 by Leave a Comment
The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug. The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation…
FDA Advisory Panel Offers Cautious Support For Polypill
September 10, 2014 by Leave a Comment
The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for…
FDA Once Again Reaches Conclusions At Odds With Its Own Staff
July 14, 2014 by Leave a Comment
Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided…
FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant
July 10, 2014 by Leave a Comment
A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect. REGULATE-PCI is a phase 3…
FDA Ends Olmesartan Safety Review, But…
June 24, 2014 by Leave a Comment
The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk of cardiovascular death. Now the FDA says that it…
FDA Recalls Another Batch Of Generic Metoprolol
June 24, 2014 by Leave a Comment
The FDA has recalled more than 13,000 bottles of metoprolol succinate extended release tablets manufactured by Dr. Reddy’s Laboratories. Two months ago the agency recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with…
Yet Another Delay For Boston Scientific’s Watchman Device
June 17, 2014 by Leave a Comment
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said…
FDA Approves Novel Implanted Sensor To Monitor Heart Failure
May 28, 2014 by Leave a Comment
The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted…
FDA Rejects Novel Novartis Drug For Acute Heart Failure
May 16, 2014 by Leave a Comment
Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. … Click here to read the full post…
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