AstraZeneca May Shed Thousands More Jobs
Two years after announcing plans to eliminate more than 10,000 jobs, AstraZeneca is reportedly set to shed thousands more when the drugmaker announces earnings later this week, according to a report in The Sunday Times that cited securities analysts. We asked an AstraZeneca spokesman about the report, but he declined to comment on what he […]
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FDA dings Hospira for ‘misleading’ ads for blood drug
The U.S. Food and Drug Administration has admonished Hospira Inc. for overstating the capabilities of a product used to offset severe blood loss. The FDA has asked the Lake Forest-based medical products manufacturer to change its marketing of Voluven, a plasma substitute designed to increase patients’ blood volume after surgery or trauma. In an apparent […]
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EU could make API suppliers verify starting material sources
EU could make API suppliers verify starting material sources Europe is considering forcing API manufacturers to verify the source of starting materials as part of GMP revisions.
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Ranbaxy Labs Gets A Sweeping Consent Decree
Filing false data with the FDA can cause problems. Just ask Ranbaxy Laboratories, which last month agreed to pay a $500 million fine and accept a consent decree for a raft of manufacturing violations (back story). Now, the US Department of Justice has released more details – the feds have filed a consent decree for […]
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Celgene To The FDA: Oh… That White Paper
You can get all sorts of things when you pay $2.9 billion for a biotech, including an admonition from the FDA. That’s what happened to Celgene last month, when the FDA issued a stern letter for a troublesome white paper that Abraxis BioScience had distributed at the American Society of Clinical Oncology meeting nearly two […]
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Pakistan Arrests Pharma Execs Over Patient Deaths
Here is an instance in which executives are being held directly accountable for alleged harm to patients. Pakistan yesterday arrested the owners of three drugmakers whose cardiac medicines have been blamed for causing the deaths of 63 patients. The drugs had been sent last month to the Punjab Institute of Cardiology for distribution to poor […]
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Paula Deen Publicist Quits Over Novo Nordisk Deal
More fallout from the Paula Deen controversy. The long-time publicist for the self-proclaimed ‘Queen of Southern Cuisine’ has quit. The departure was disclosed just one week after Deen signed up as a spokeswoman for Novo Nordisk, which sells diabetes treatments, but failed to disclose she learned three years ago that she has the disease, even […]
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Fabry Patients Press Lawsuit Despite Plant Approval
Over the past few days, Genzyme has finally received good news about its flagging manufacturing efforts. Both the FDA and the European Medicines Agency have approved a plant in Framingham, Massachusetts, for the production of Fabrazyme, a medicine used to treat Fabry disease, a rare, but life-threatening genetic disease. The approvals follow a protracted period […]
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Lonza boots out CEO as 2011 profit plunges
Swiss drugs industry supplier Lonza (LONN.VX) (LONZ.SI) kicked out chief executive Stefan Borgas after profits for 2011 plunged by a third and said 2012 was set to pose further challenges because of the difficulties faced by pharmaceutical firms. The Basel-based group, which is battling currency headwinds and volatile raw material prices, said the board took […]
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Bristol-Myers, FDA & A Lack Of Safety Warnings
Here is a twist on the old adage, ‘If a tree falls in a forest, does anyone hear it?’ Seven months ago, Bristol-Myers Squibb changed the label on its Kenalog steroid shot, which is frequently administered in epidural injections, to alert physicians that the medication should not be used near the spine after there were […]
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