Category Archives: Medical Device

This Week’s Life Science Headlines

        Litigation

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New Liver Disease Medical Device May Help Cut Number of Transplants

Royal Free Hospital in London is conducting a trial of a new medical device to treat liver disease on a group of patients with severe alcohol-related liver failure.  Results have already shown that that patients’ liver damage can be reversed, which can dramatically improve a patient’s quality of life.  The new device, called an alfapump, is manufactured by the Swiss medical device company Sequana Medical and may radically change the treatment options for patients with severe liver disease in the future. Liver disease impacts the…

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This Week’s Life Science Headlines

        Litigation

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The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight

The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women…

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This Week’s Life Science Headlines

        Litigation

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

FDA Rule Proposal Could Lead to Liability for Generic Drug Manufacturers

The U.S. Food and Drug Administration (FDA) is proposing new rule changes that would permit generic drug manufacturers to amend drug warning labels when they receive new information related to drug safety; irrespective of whether the revised labeling differs from the brand name manufacturer. The proposed rules further provide that the generic manufacturer would be required to submit the labeling changes along with the data supporting the change to the FDA, which would review the request and post the data in a public web page.…

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Despite Reported Risks, Side Effects and Threatened Litigation, Crestor Top Selling Drug

According to a report by the research firm IMS Health, (free membership login required) new prescriptions and refills for Crestor, a drug used to lower cholesterol, exceeded all other prescribed drugs in the United States between October 2012 and September 2013. Crestor (rosuvastatin), like Lipitor (atorvastatin) is widely-used to lower cholesterol and belongs  to a family of drugs called “statins.” Among the best-selling drugs in the United States, statins use the liver to block the body’s creation of cholesterol, which is a key contributor…

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