A Grieving J&J Employee And Cubicle Photos
NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance In 2003, Cecelia Mavica Ingraham, an administrative assistant in a marketing department at Johnson & Johnsons’ Ortho-McNeil Pharmaceutical unit, learned that her teenaged daughter had acute lymphocytic leukemia. By May 2005, her daughter had passed away, but […]
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Merck Wins A Bellwether Fosamax Trial
NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance A federal court jury this morning decided that the Fosamax osteoporosis drug should not be blamed for causing a type of jaw damage known as osteonecrosis in which tissue is severely damaged. Linda Secrest had filed a […]
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FDA Still Trying To Become More Transparent
As part of an ongoing ‘transparency initiative‘ launched by FDA commish Margaret Hamburg, several agency officials met with their counterparts at the US Environmental Protection Agency and the US Department of Labor to find additional ways to organize and present information that so many people have difficulty finding on the FDA website. NEW WEBINAR – […]
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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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