The GiveAway Act

The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…

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Cardiac Devices Could Become a Big Problem For Califf And The FDA

–Approvals with no strong evidence of efficacy: What could go wrong?  The FDA has a big problem. It likes to approve new drugs and devices. Approvals look good politically and allow the FDA to boast each year about their large number of approvals. But when the FDA approves a drug or device that doesn’t work…

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The Impact Of ABSORB II: Down The Slippery Slope

When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…

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Novel Cholesterol Drugs Move Forward In Clinical Trials

–New information about upcoming cholesterol drugs from the Medicines Company and Esperion Recently the makers of two novel cholesterol-lowering drugs in development provided important updates on their progress. On Tuesday, the Medicines Company announced positive top-line results for a trial of its unusual PCSK9 synthesis inhibitor scheduled to be presented in November. Last week Esperion…

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FDA Reaffirms Safety And Efficacy Of Rivaroxaban

–FDA says no changes needed to the rivaroxaban label. Following a year of controversy and uncertainty relating to the anticoagulant drug rivaroxaban (Xarelto, Johnson & Johnson), the FDA has reaffirmed the drug’s safety and efficacy. Rivaroxaban is approved for stroke reduction in patients with atrial fibrillation. The indication is based on results of the ROCKET-AF…

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Experts Weigh In On The Decline In Cardiovascular Drug Development

–CV disease is the top killer but pharma is pulling back on developing new drugs. Although cardiovascular disease is the number one cause of death in the world fewer cardiovascular drugs are under development now than in the past, according to a study published in JACC: Basic to Translational Science. Thomas Hwang and colleagues at…

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FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants

  Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated…

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Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy

–FDA says the manufacturer has not demonstrated that it has fixed the problem. The  Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The…

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Empagliflozin May Be Poised To Gain CV Indication

–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…

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FDA Proposes Voluntary Sodium Cuts by Food Industry

–AMA, AHA, ACC, etc voice support, but not everyone agrees. After decades of discussion and inaction, the FDA today took a first concrete step toward reducing sodium levels in the general population: It issued draft guidance for voluntary sodium reduction targets for the food industry. The FDA said that the new recommendations come from “leading…

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FDA Ends Niacin and Fenofibric Acid Combinations With Statins

–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…

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Orexigen Terminates Another Cardiovascular Outcomes Trial

Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…

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FDA Expands Metformin Label

— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely…

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FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels

The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the  saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…

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The Door Opens Wider For Drug Companies To Make Off-Label Claims

The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA.  The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…

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At the FDA Rob Califf Will Champion Clinical Trials

Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda. Or, as one reporter tweeted: Hey, is that the sound of the FDA approving things faster? Must be because the Senate…

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FDA Turns Down Expanded Indication For Zetia And Vytorin

The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck).  This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for…

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FDA Announces Sweeping Changes In Approach To Opioid Drugs

The FDA announced today that it planned sweeping changes in its approach to opioids drugs. The move comes in response to growing concerns over abuse of prescription opioids in the US and escalating criticism of the FDA’s lackluster response to the problem. Two US Senators have said they would oppose President Obama’s nomination of Robert…

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Four Senators Now Oppose Califf Nomination To Head The FDA

(Updated on January 26 and January 27) US Senator Edward Markey, a Democrat from Massachusetts, is seeking to block Rob Califf’s nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination. In September President Obama nominated Califf, a well-known Duke…

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Live Blog: The FDA Advisory Panel On IMPROVE-IT

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New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf

(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…

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A Few Observations About Rob Califf’s Picnic With The US Senate

I’m no expert on Washington politics but judging from the senate committee hearing today Rob Califf is going to be the next FDA commissioner. With the exception of Bernie Sanders, who had already announced his opposition, the committee members treated Califf with kid gloves. [Click here to read my live blog of the hearing.] Lamar…

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Live Blog: Senate Hearing On Rob Califf’s Nomination For FDA Commissioner

12:00 Hearing adjourned. It sure looks like Rob Califf will be our next FDA commissioner.  11:58 Scott asks about the high rate of heart disease and diabetes in South Carolina. The high cost of trials is preventing cures for these diseases. Califf asks how many hours he has to answer the question. Califf notes we have…

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Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…

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Possible Setback For Califf On Road To FDA

Rob Califf may have just run into his first serious roadblock on his path to become the FDA’s next commissioner. According to a report in the Boston Globe, Califf removed his name as a co-author from a series of papers, some of which were critical of current FDA policy. Until now Califf’s nomination has not encountered a…

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