Finally, J&J Resumes Some Tylenol Shipments
For more than a year, we have spent considerable time tracking the ongoing and rather impressive number of recalls by Johnson & Johnson which, you may recall, blundered into a series of manufacturing gaffes and questionable coping strategies that generated an FDA probe; congressional hearings; lost sales; a closed plant; managerial changes; eroded consumer confidence; […]
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Yag Mag Labs Private Limited 9/12/11
Mr. M. Soma Raju Yag-Mag Labs Private Limited Plot 7, Flat 301 Besides Andhra Bank, Sundar Nagar, Near ESI Hyderabad 500 038, Andhra Pradesh, India Dear Mr. M. Soma Raju, During our June 27 to July 2, 2011 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Yag-Mag Labs Private Limited located at Survey No. […]
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Strides Gets Continued US FDA Approval Status For Its Oral Dosage Facility
Strides Arcolab said US FDA recently inspected its Oral Dosage Forms manufacturing facility in KRS Gardens in Bengaluru, as part of GMP compliance audit, and the facility continued to be approved with Zero Inspectional Observation’ reported in FDA 483. The last US FDA inspection and approval for this facility was in the year 2008. The […]
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FDA Blocks Products Made By API Supplier
In yet another bid to get tough on foreign manufacturers, the FDA has not only issued a warning letter to an active pharmaceutical ingredients supplier based in India, but has also imposed a so-called Import Alert, which means its products will not be allowed into the US. NEW WEBINAR – What You’ve Got to Know […]
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Medicis Pharma CEO Wants Deaths Investigated
Two months ago, Medicis Pharmaceutical ceo Jonah Shacknai suffered a double blow – his six-year-old son fell down the stairs and died at a hospital five days later. Two days later, his 32-year-old girlfriend was found hanging – naked, with her feet bound and wrists tied behind her back – in the courtyard of his […]
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Boehringer, Pradaxa & Manipulating The Public
In its rush to promote its Pradaxa bloodthinner, Boehringer Ingelheim has brought shame on pharma. A doctor complained to an industry overseer that a series of newspaper articles that were published earlier this year referred to an unapproved indication, exaggerated claims and disparaged a rival medicine. NEW WEBINAR – What You’ve Got to Know About […]
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Vaccine Maker Downplays Link To Side Effects
Three months ago, the FDA issued a harsh warning letter to CSL, a big maker of flu vaccines based in Australia, as a follow up to a March 2011 inspection. And that visit generated a 483 report showing that CSL had no idea how to properly conduct an investigation to determine why fevers and convulsions […]
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WTF?! New FDA Offices And New FDA Acronyms
The FDA continues its reorganization and as part of the transformation, the Office of Medical Policy has been rearranged into a so-called super office that will oversee regulation of prescription drug promotion and advertising; provide advice on clinical trial design; and direct policy issues concerning human subject protection and good clinical practices. The new director […]
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Insider Trading, Drug Stocks & A Columbia Professor
Six months ago, the Massachussetts Secretary of the Commonwealth had filed a complaint that accused a hedge fund of making profits on two drugs stocks by using insider information. Specifically, Risk Reward Capital Management was charged with using expert consultants to obtain advance info about an Ariad Pharmaceuticals clinical trial and a forthcoming abstract about […]
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Those Merck Layoffs Are Imminent For Some
A few weeks ago, Merck disclosed plans to trim another 12,000 to 13,000 jobs by the end of 2015 in order to save up to $1.5 billion. This is on top of previously announced cuts although efforts to reduce headcount are forcing managers to accelerate their plans. NEW WEBINAR – What You’ve Got to Know […]
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