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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The Wiseguys Are Stealing Fewer Pharmaceuticals
Are those Sopranos wanna-bees meeting stiffer resistance from the pharmaceutical industry security experts? A new report shows that the number of thefts of pharmaceutical shipments declined significantly last year – there were fewer incidents and a much lower average value per theft, according to the latest report from Freightwatch International, which tracks global cargo thefts. […]
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EMA Probes Novartis MS Pill Over Deaths
One month after Novartis initiated an investigation into a death tied to its new Gilenya pill for multiple sclerosis, the European Medicines Agency has now launched its own probe after receiving reports of up to 11 deaths among patients who took the medication. This includes the first death that the drugmaker reported initially (here is […]
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Novo Must Get Rid Of Paula Deen: Kliff Explains
Earlier this week, Paula Deen, the self-styled ‘Queen of Southern Cuisine’ and Food Network star, disclosed that she not only had Type 2 diabetes for the past three years, but had just signed up as a paid spokesperson for Novo Nordisk, which sells various diabetes treatments (back story). The reaction was fast and furious – […]
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FDA warns J&J’s DePuy for selling unapproved device components
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics finds itself in the FDA spotlight, according to a warning letter released by the agency’s Centers for Devices & Radiological Health this week. The watchdog agency detailed more than a dozen devices or device components it said lacked proper PMA clearance or which were modified in ways that […]
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