How To Delay Generics? Draw A Line On A Pill
Here is a novel way to thwart generic competition. Simply add a so-called score, or line, across a tablet and the FDA may force generic rivals to rework their own versions, which amounts to a delay in approval. Meanwhile, the cash register at the brand-name drugmaker offices will keep ringing. That’s what Warner Chilcott hopes […]
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Drugmakers Lose Another Hepatitis C Trial
For the second time in a year and a half, Teva Pharmaceuticals and Baxter Healthcare have a lost a trial in which a jury determined they contributed to a 2008 hepatitis outbreak in Nevada due to the way the Propofol medication was marketed. Another defendant was McKesson, the big distributor. The jury awarded three people […]
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FDA Approves Cialis to Treat Enlarged Prostate
Cialis has been approved by the FDA for the treatment of enlarged prostate. It may also be used to treat men who have both enlarged prostate and erectile dysfunction (ED) at the same time. Cialis is the first ED drug to be approved for treating benign prostatic hyperplasia (BPH). Commonly known as enlarged prostate, symptoms […]
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Congress Probes Distributors Over Drug Shortages
Secondary drug distributors are now the focus of a congressional probe in the worsening prescription drug shortage. Elijah Cummings, the ranking Democrat on the House Oversight and Government Reform Committee, has given five distributors two weeks to respond to questions after hospitals have complained that they have received offers of hard-to-find meds at huge mark-ups. […]
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Drugmaker Floods FDA With Patient Death Reports
Two years ago, the FDA inspected Actelion Pharmaceuticals offices and found the drugmaker failed to follow proper procedures for reporting adverse events and, as a result, about 3,500 patient deaths were never filed with the agency. A follow-up warning letter was issued and, in response, Actelion went to the other extreme – every adverse event […]
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AstraZeneca To Cut 400 Jobs In The US
And still more jobs are being shed. With patent expirations looming for some of its biggest sellers, AstraZeneca is shrinking its US commercial business and will eliminate about 400 jobs at its Wilmington, Delaware, headquarters. Most of the cuts, therefore, will come from various administrative and support departments, as well as an unspecified number of […]
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FDA Issues Warning for Drug Alleged to Cause Elon Student’s Death
The FDA has issued a warning for a birth control drug alleged to have caused an Elon student’s death just over a year ago. Michelle A. Pfleger, a first-year student from Hackettstown, N.J., died Sept. 24, 2010, after collapsing while on her way to class. The Alamance County Medical Examiner determined Pfleger died of a […]
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FDA Issues Yet Another Warning Over Celexa Use
The FDA has issued a drug safety alert for the antidepressant Celexa (citalopram, also available as a generic), reducing the recommended maximum daily dosage to 40 mg/day. The alert is due to a new study which found the previously recommended higher dose of 60-mg/day can cause abnormal changes in the electrical activity of the heart. […]
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FDA Adds Risk of Ovarian Failure to Avaistin’s Warning Label
Treatment with the cancer drug Avastin may affect fertility in some women, the Food and Drug Administration (FDA) said Tuesday. The agency said a new warning about the risk of “ovarian failure” was added to the drug’s label. The FDA further advised doctors to counsel women of child-bearing age about the possibility that taking Avastin […]
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So Many Jobs Are Gone, Pharma Layoffs Dwindle
As you know, this has not been a good decade for pharma employment. The combination of patent expirations, thinning pipelines and fewer new drug approvals has prompted every drugmaker – big and small – to toss tens of thousands of people overboard. But so many jobs have been eliminated that the layoff pace is finally […]
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