Extravagant ‘Germbullet’ Drug Claims Do Not Amuse FDA and FTC
source File this under ‘such chutzpah!’ On a web site that can only be described as breathless, Flu & Cold Defense boasts that its GermBullet, a ‘natural proprietary blend of 11 organic botanicals,’ was ‘independently tested’ by an ‘FDA recognized virology lab’ and the product was found to have ‘the potential capability to kill cold […]
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GSK Won’t Settle With UK Avandia Patients
source Although GlaxoSmithKline agreed to settle lawsuits filed in the US by people who claimed they were harmed by the controversial Avandia diabetes pill, which was linked to heart attacks and strokes, the drugmaker is reportedly refusing to adopt the same approach in the UK. Instead, Glaxo is preparing to fight at least four complaints […]
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Tougher Painkiller Limits Needed by FDA?
Source After a widely anticipated two-day hearing late last week, an FDA advisory panel voted 19-to-10 to place Vicodin and other prescription painkillers that contain hydrocodone under greater restrictions. The agency is likely to follow the recommendation, but the debate over such a move is unlikely to have ended. At issue is an increasing effort […]
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More Trouble at J&J, This Time Over Data for Hip Implants
Source Last week was significant for Johnson & Johnson ceo Alex Gorsky in different ways. For one, it was the first time that he presided over a discussion of an annual earnings report as ceo of the healthcare giant. At the same time, J&J made headlines, once again, over a potentially scandalous disclosure of previously […]
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J&J Keeps Troubled Consumer Unit
source In case anyone was wondering, Johnson & Johnson ceo Alex Gorsky is trying to make clear that the healthcare giant has no intention of unloading its troubled McNeil Consumer Healthcare unit. In remarks to Wall Street analysts this morning to discuss earnings, Gorsky says that J&J is “absolutely committed†to the struggling unit, which […]
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NIH Committee Retiring Most Research Chimps
source In a closely watched recommendation, a National Institutes of Health working group has recommended that the agency retire all but 50 chimps for use in medical research. The proposal, which comes after the NIH decided in late 2011 to phase out most research using chimpanzees, means that hundreds of chimps will be sent to […]
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Ben Venue Labs Hit With Consent Decree
source Two years after quality-control problems caused severe shortages of several medicines and later prompted manufacturing to be suspended at a troubled facility in Ohio, Ben Venue Laboratories has entered into a consent decree with the FDA. Among the many drugs for which shortages were caused by the difficulties was the Doxil cancer medication sold […]
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Antibody Supplier Faces Lawsuit for Cruelty to Animals
source In the latest instance in which animal-rights activists are placing pressure on biomedical research, one such group has filed a lawsuit against a California company, which supplies antibodies to laboratories, for violating state cruelty and unfair competition laws. The group, Stop Animal Exploitation Now, claims that Santa Cruz Biotechnology, has provided improper care […]
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States Create Biosimilar Laws, Regardless of FDA Inaction
Source The FDA may not have approved a biosimilar yet or decided whether a biosimilar is interchangeable with a brand-name biologic, but this is not stopping some state legislatures from considering bills that would allow substitution. So far, three six states have legislation in the works and such efforts may gain momentum this year, according to the FDA […]
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GSK Enters the Small Business Hall of Shame
Source Cost cutting is an age-old practice and the pharmaceutical industry has certainly sharpened its skills in recent years. Now, though, a move by GlaxoSmithKline to increase the time by which payments are made to some of its suppliers has earned the drugmaker the distinction of being named to the ‘Hall of Shame’ by the […]
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