For Cephalon, Nearly As Many Probes As Drugs
Late last week, Cephalon disclosed yet another government investigation into its handling of one of its drugs. The latest probe is being conducted by the US Department of Justice into “certain promotional practices†concerning the Nuvigil and Provigil medications, which are used to treat sleeping disorders. NEW WEBINAR – What You’ve Got to Know About […]
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Chinese API Maker Gets Stern FDA Warning Over Cross Contamination
Chinese API maker Sichuan Pharmaceutical finds itself on the stinger end of a warning letter just posted to the FDA website. The warning follows two attempts by the drugmaker after a June 2010 inspection to convince the agency it has its previous cross-contamination shortcoming back up to par. It hasn’t achieved that goal. And the […]
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How the FDA Could Cost You Your Life
When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death. Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through […]
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Roche adds manufacturing operation at Nutley to supply clinical trials
The drug company Roche has revived part of its Nutley campus with a new manufacturing operation designed to produce supplies of compounds being studied as prospective medicines. The Roche Center of Excellence — as the manufacturing operation will be called — will make dosage forms of potent compounds that are being studied in different phases […]
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21: days of protection left for Lilly’s Zyprexa
Now the countdown is no longer in years or months. It is in days — just 21 more. On Oct. 23, Eli Lilly and Co. will lose U.S. patent protection on Zyprexa, the best-selling drug in its 135-year history. On that day, generic competitors can launch low-priced versions of the powerful antipsychotic drug that doctors […]
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Abbott Labs to cut 160 jobs from testing unit
Abbott Laboratories will eliminate 160 jobs from its diagnostic division as part of a multiyear effort to cut costs and boost revenue for the business. The company, based in North Chicago, Ill., notified employees Tuesday that it would cut 150 manufacturing positions from its Santa Clara, Calif., location by the end of 2012. The action […]
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Pfizer Wins Big Prempro Case In New Jersey
A New Jersey appeals court late last week ruled that Pfizer cannot be sued by two women who argued that the drugmaker’s hormone replacement therapies caused their breast cancer. The decision upheld a ruling back in 2008 (back story) and, significantly, places a question mark over the fate of more than 150 similar lawsuits that […]
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FDA Calls in Calvalry on Yaz Safety Analysis
FDA has called in the cavalry for help reviewing the safety of Bayer’s Yaz line of birth-control pills. The agency plans to convene an advisory panel in December to sift through the evidence on the contraceptives–and their generic equivalents–which contain drospirenone, a synthetic version of the hormone progestin. And in the meantime, it’s warning women […]
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Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives
Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives Contact: Consumer: 1-877-300-6153 Media: Kevin Wiggins (610) 459-7281 FOR IMMEDIATE RELEASE – September 15, 2011 – Qualitest Pharmaceuticals today issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were […]
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CSL Trying to Resolve FDA Concerns
Pharmaceutical company CSL says it has addressed the majority of manufacturing flaws highlighted by FDA and remaining concerns are currently being resolved. Audits carried out by the FDA in 2010 and 2011 revealed “objectionable conditions and practices” within CSL, News Ltd reported on Thursday. Allegations include the failure of laboratory staff to wear masks while […]
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