The Clot Thickens: FDA Staff Do Not Like Xarelto
In a blow to Bayer and Johnson & Johnson, FDA medical reviewers have questioned the effectiveness of their Xarelto bloodthinner and suggested the agency issue a complete response letter, which generally means that marketing approval for a drug is denied until additional data is required, according to documents released today ahead of a scheduled FDA […]
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The Axe Swings: Sanofi To Cut $2.9 Billion In Costs
Fresh from its acquisition of Genzyme, Sanofi now plans to cut another $2.9 billion in costs in hopes of coping with upcoming expiration of patents on big-selling meds, notably the Plavix bloodthinner and Avapro high blood pressure medicine. The move is designed to boost earnings by about 5 percent annually, although there were no details […]
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Are The Feds Probing The Dendreon ‘Bear Raid?’
Last year, the US Securities and Exchange Commission’s Office of Inspector General released a report indicating the agency’s Enforcement Division was investigating allegations into market manipulation and a “bear raid†on shares of Dendreon, the maker of the controversial Provenge prostate cancer vaccine. A bear raid occurs when a trader tries to force down the […]
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Pfizer Superfund site breached by floodwaters
The chemical lagoons at the American Cyanamid Superfund site were breached by hurricane floodwaters, the U.S. Environmental Protection Agency reported. The lagoons have been seeping carcinogenic benzene 20,000 times regulatory levels all year into the Raritan River, according to the EPA, which has collected samples of floodwaters from the 400-acre site. Results should be known […]
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A Grieving J&J Employee And Cubicle Photos
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 a problem arose in the workplace – for some 18 months, Ingraham continued to openly grieve, and displayed […]
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Dead CEO Girlfriend Death Ruled Suicide
Investigators have concluded that a woman found dead, hanging naked and bound at a historic Coronado, Calif., mansion in July, killed herself, the sister of the victim said Thursday. Rebecca Zahau was found dead, naked, hanging with her hands and feet bound, at a mansion in Coronado, Calif. An attorney for the victim’s family blasted […]
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Merck Sues Kentucky For Outsourcing Vioxx Suit
Outsourcing is all the rage these days and some state attorneys general are no exception. Take the sprawling Vioxx litigation. More than one state attorney general has retained an outside law firm to help with efforts to recover money from Merck for allegedly defrauding the public over the heart risks associated with the painkiller, which […]
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Pfizer’s Lipitor Webpage Is Slammed By FDA
Once again, a web page is deemed problematic by the FDA. In a letter sent by the agency earlier this week, Pfizer was chastised because its Lipitor web page made misleading representations and suggestions about several other drugs. The issue came to light, by the way, thanks to the FDA ‘Bad Ad’ program, which encourages […]
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FDA chemist near plea over insider trading charges
A Food and Drug Administration chemist and his son accused of making millions of dollars with inside information about drug approvals are close to reaching plea agreements, according to court papers. Federal prosecutors charged Cheng Yi Liang and his son Andrew in March with conspiracy, securities fraud and wire fraud for making $2.27 million in […]
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Off-Label Avastin Injections Linked To Blindness
At least 16 people in Florida and Tennessee have suffered serious eye infections, and some were blinded, after being injected with Avastin. And regulators and the manufacturer say the injuries underscore the risks associated with the unapproved use of the drug, which some doctors reach for when treating the wet form of age-related macular degeneration. […]
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