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Bayer 137 articles

Judge upholds whistleblower claims against Bayer over off-label Trasylol marketing

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Two whistleblower claims accusing Bayer of promoting its heart surgery drug Trasylol for unapproved purposes will move forward after a New Jersey federal judge on Monday again declined the drug maker’s motion to dismiss the case. In March, U.S. District Judge Jose Linares refused Bayer’s motion to drop the False Claims Act case. Bayer asked Judge Linares to reconsider the March order, arguing that the court missed its arguments that whistleblower Laurie Simpson failed to demonstrate how its alleged wrongful marketing of Trasylol amounted to a submission of false claims to the government. Bayer also argued the court overlooked its ... Read More

Bleeding side effects, lawsuits may hurt future Xarelto sales

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Sales of Pfizer’s new blood thinner Eliquis have grown more than fivefold in the previous year to a whopping $774 million, but analysts say Johnson & Johnson and Bayer need not fret just yet about the fate of their blockbuster blood thinner Xarelto. Xarelto has the lion’s share of the anticoagulant market of the new lineup of blood thinners known as Xa inhibitors. Boehringer Ingelheim’s Pradaxa, which hit the market in 2010, was the first in the class of drugs designed to go head-to-head with the long-used warfarin for the prevention of strokes in patients with atrial fibrillation. Pradaxa revenues grew ... Read More

Xarelto, GranuFlo and NaturaLyte lawsuit filings increase in April

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The largest increases in product liability filings involving pharmaceuticals last month were seen in claims against Bayer and Janssen Pharmaceuticals’ blood thinner Xarelto, and Fresenius Medical Care’s dialysis concentrates GranuFlo and NaturaLyte, according to Reuters’ analysis of statistics from the U.S. Judicial Panel on Multidistrict Litigation. Bayer and Janssen, a subsidiary of Johnson & Johnson, have enjoyed billion-dollar profits from their blood thinner Xarelto since it hit the market in 2011. Xarelto has since been approved for multiple indications including stroke prevention in patients with nonvalvular atrial fibrillation, treating and preventing blood clots in the legs and lungs, and preventing blood ... Read More

Xarelto makers not worried about blood thinner’s competition

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It’s a dog-eat-dog world out there, especially in the pharmaceutical industry. And no one wants to admit when the chips are down. But drug company Bayer is totally blowing off concerns that its blockbuster blood thinner Xarelto may be losing market share in the United States to Bristol-Myers Squibb’s Eliquis. Xarelto and Eliquis are blood thinners that are used to prevent strokes and blood clots in patients with a heart condition known as atrial fibrillation, prevent and treat blood clots in the legs and lungs, and prevent blood clots in patients undergoing knee or hip replacement therapy. The drugs are ... Read More

Judge nixes Bayer’s plan to reinstate whistleblower

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An Arkansas federal judge who ordered the reinstatement of a whistleblower terminated after implicating Bayer Corp. in a Medicare fraud scheme rebuked the pharmaceutical giant for attempting to reinstate the former employee to a job 500 miles away. Bayer fired sales representative Mike Townsend in 2010 after he blew the whistle on a scheme by a major Bayer customer to defraud Medicaid by illicitly billing the program for intrauterine contraceptives. Mr. Townsend had worked as a Bayer sales rep for six years when he caught on to a Medicaid scam he alleges was orchestrated by Arkansas physician Kelly Dean Shrum, ... Read More

Pradaxa antidote granted breakthrough designation

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The Food and Drug Administration (FDA) has granted breakthrough designation for Boehringer Ingelheim’s idarucizumab, a reversal agent to its blockbuster blood thinner Pradaxa. The accelerated review process will cut about four months off the review process for the medication. Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA can grant breakthrough designation to specific drugs that meet set criteria such as therapies that are used individually or in combination with other drugs to treat a serious or life threatening disease or condition, or those in which preliminary data shows evidence that the medication may provide ... Read More

California man sues Xarelto makers over bleeding risks

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Makers of the blood thinner Xarelto overstated the effectiveness of the drug, failed to fully research the medication to better understand the risks, and knowingly concealed problems associated with the drug, according to a lawsuit filed by a California man. Kenneth Niemeier claims he suffered injuries after being treated with Xarelto, resulting in physical pain, mental anguish, diminished enjoyment of life, loss of earnings and medical expenses. His lawsuit names Janssen Research & Development, a subsidiary of Johnson & Johnson, and Bayer Healthcare Pharmaceuticals, alleging product liability. Xarelto is an anticoagulant used to prevent or treat blood clots in patients ... Read More

IUD side effects may outweigh benefits

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Women who used an intrauterine device, or IUD, were less likely to develop preeclampsia in subsequent pregnancies, but the protective effect was only found in women who had never been pregnant before getting the IUD, according to a new study. Intrauterine devices, such as the Mirena IUD, are T-shaped devices that are inserted into the cervix to prevent pregnancy. IUDs are considered highly effective but they are not 100 percent effective. The risk of becoming pregnant while implanted with an IUD are greatest during the first year, and women who become pregnant with an IUD in place are at greater risk of ... Read More

Bayer banks on sales of blood thinner Xarelto

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Bayer announced it plans to increase sales for its main Healthcare division by 6 percent on average through 2017 to more than $26.7 billion by hanging its hat on new drugs, such as the blood thinner Xarelto. The company says rising sales of these newer drugs have helped offset declines of its birth control pill and multiple sclerosis treatment in the face of competition. Bayer teamed up with Johnson & Johnson subsidiary Janssen Pharmaceuticals to produce Xarelto, which became the second drug in a new class of blood thinners called Xa inhibitors. The anticoagulant is used to prevent or treat blood ... Read More

FDA approves new IUD

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A new intrauterine device (IUD) for birth control has been approved by the Food and Drug Administration (FDA). Liletta, which is already approved in Europe, is similar to Bayer’s Mirena and Skyla IUDs, which work by releasing a small amount of the hormone levonorgestrel. The approval is based on a comprehensive study of 1,751 women during which the device was found to be 99.45 percent effective at preventing pregnancy over a three-year period. The device showed effectiveness in women regardless of age, body mass index, or whether they had previously given birth. The study participants will continue to be followed ... Read More