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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FDA Blasts DePuy Orthopaedics Over Regulatory Problems
The FDA is blasting DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over the selling of artificial knee and hip replacement implants without FDA approval. The FDA issued a warning letter to DePuy Orthopaedics in December about the regulatory problems, after inspectors visiting a plant in Warsaw, Indiana discovered implants being manufactured there that were […]
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FDA Warnings Are Often Ignored or Misinterpreted
Researchers have broken down the way in which the U.S. Food and Drug Administration notifies the general public and health care providers about unanticipated risks from approved medications into four different categories: warnings about serious harmful events, recommendations against use in certain patient populations, averting harmful drug-drug interaction, and calls for increased lab or clinical […]
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FDA May Approve Pot-Based Prescription Drugs
The US Food and Drug Administration may be close to approving prescription drugs derived from marijuana. It was almost 25 years ago, that the FDA first approved pot-based drugs, but now other derivatives may soon show up on pharmacy shelves nationwide thanks to the research efforts of UK- based GW Pharma. The company is now […]
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BioMarin’s Dwarfism Medicine Marks Growth of $400,000 Rare-Disease Drugs
David Blaustein waited seven years for the phone call that finally came in December 2010 from BioMarin Pharmaceutical Inc. (BMRN), a maker of medicines for rare diseases. Blaustein’s 8-year-old son has achondroplasia, a genetic condition that’s the most common form of dwarfism. A doctor turned investor, Blaustein spent years trying to find any company focused […]
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Roche Meds In Short Supply Over Plant Problems
Yet another drugmaker is suffering manufacturing problems that are causing supply disruptions for several widely used meds. The latest is Roche, which has issues at its Florence, South Carolina, plant and reports varying shortages of the Xenical diet pill; Tamiflu; the Valcyte eye med; the Pegasys component for a hepatitis C treatment and the Xeloda […]
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Drug lobby wants clearer FDA rules for diet pills
The pharmaceutical industry may stop investing in medicines to treat diseases like diabetes or obesity without more explicit guidelines from U.S. regulators, the chairman of the drug trade group said on Thursday. The Food and Drug Administration must approve any medical products sold in the United States, but drug companies say they cannot always predict […]
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