What You Must Know About New Cholesterol Guidelines
The American Heart Assn. and the American College of Cardiology this week came out with new cholesterol guidelines that are designed to cut down on cardiovascular risks. They are a marked change from the last guidelines, which were last updated 9 years ago. Here are the most important things that people must know: 1. The […]
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Shire Cutting More UK R&D Jobs – CEO Overhauls Operations
Shire Pharmaceuticals Plc is cutting UK research jobs and is going to move its Swiss operations as one part of a large reorganization that is being spearheaded by CEO Flemming Ornskov. About 200 employees at Shire’s HQ in the UK in Basingstoke may lose their jobs. The company also is planning to move its Swiss […]
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FDA Trying to Increase Placement of Auditors in China
FDA has reported this week that getting visas approved for new FDA inspectors in China is taking longer than they hoped. The idea was for FDA to double its presence in that country. The delays are continuing as FDA has only eight auditors based in China. It asked the government there in 2012 about being […]
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J&J Pays $2.2 Billion to End FDA Drug Probes
Johnson and Johnson is going to pay over $2 billion to bring an end to various civil and criminal investigations regarding kickbacks to pharmacists and for marketing drugs for various off label uses. The US Attorney General made this announcement on Monday. This case is finally being resolved and dealt with the marketing of two […]
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FDA Looking Into Advertising of ADHD and Acne Drugs in Teens
FDA wants to understand better how teenagers perceive commercials that are aimed at them for treatments for acne and also attention deficit hyperactivity disorder, or ADHD. FDA is going to show teens fake sites that FDA will come up with for fictitious drugs that are used to treat acne and ADHD, and will see how […]
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GlaxoSmithKline Execs Facing Bribery Charges in China
Chines officials who have been investigating allegations of bribery and other corruption at GSK are going to probably charge some Chinese execs, but probably not the company Glaxosmithkline itself. A charge against the company would be a very serious problem for the pharma firm, because it would imply that there was high level corporate corruption […]
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DOJ Launches Investigation of Astrazeneca’s Brilinta Clinical Trial
Astrazeneca has a new headache to handle with its Brilinta blood thinner medication. The drug was picked by analysts in recent months as one of the biggest let downs. It was expected to sell more than two billion dollars per year, but now most analysts don’t think it will sell more than $1 billion. Now, […]
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New Study Casts Doubt on FDA Shorter Drug Approval Timeframe
Newer drug treatments that receive an expedited review by FDA are now being tested on fewer numbers of people. This can leave many safety issues open even after FDA approval. According to a study that was released by the Journal of the American Medical Assn., development timeframes, clinical tests and risks associated with twenty drugs […]
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Vertex to Chop Over 300 Jobs, Pay Back MA Tax Credits
Vertex Pharmaceuticals once represented the explosive growth of the biotech industry in Massachusetts. Over the last 24 months, the company has gotten FDA approvals to sell hepatitis C drugs and also drugs to combat cystic fibrosis. It emerged in that time as one of Wall Street’s favorite companies. But this week, the momentum stopped. Only […]
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FDA Issues Recall for B. Braun Medical Antibiotic
FDA has alerted doctors in the US about the recall of an injectable antibiotic that is made by B. Braun Medical, because of floating particles that were found in some vials of the antibiotic. FDA posted this notice late today, and it warned that the company had recalled some lots of Cefepime for Injection USP […]
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