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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Government Shutdown Affecting FDA Drug Approvals
With the federal government shutdown in its second week, FDA is seeing delays in the approvals of new drugs. The FDA shutdown is starting to delay PDUFA dates for firms that are looking to get near term FDA approval. FDA panel reviews for new drugs that are under regulatory review also are getting delayed. Markets […]
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FDA Acting at Lower Capacity During Shutdown, But User Fees Helping
FDA as of Oct. 1 is operating at about 1/2 its normal capacity, due to Congress not passing a bill to appropriate funds to operate the US government, according to FDA. At the RAPS regulatory conference in Boston last week, the effects of the current shut down were evident. Even with hotel rooms already booked, […]
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FDA Favoring DUNS for Manufacturing Plant IDs in FDASIA
FDA stated early this month that the DUNS system is what it prefers for the identification of drug facilities, according to new draft guidance by the agency. This decision is coming after the signing of FDASIA, or the Food and Drug Administration Safety and Innovation Act. The new law has had a major effect on […]
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