Who Participates in Medical Research?
source This will probably not come as a shock, but just 11 percent of adults and only 5 percent of children in the US have ever participated in medical research, according to a recent survey. Yet, this is not due to ignorance – 64 percent of adults and 12 percent of parents of children younger […]
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13 Biosimilar Bills In State Houses
Source As more than a dozen state legislatures mull over bills that would make it more difficult to allow substitution of biosimilars, at least one effort appears to have gone nowhere. Despite identical bills that were introduced in the state Senate and House in Mississippi, the twin pieces of legislation failed to proceed to committee […]
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FDA Dumps Bar Code Experiment With Compounder
source In the wake of the fungal meningitis outbreak that was linked to a compounding pharmacy and has so far caused as many as 45 deaths, the FDA has nixed an experiment proposed several years ago by a different compounding pharmacy that hoped to use bar codes after its medicines were shipped as a way […]
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Dirty Goggles Tripping Up Novo Nordisk
source No, this is not about making fashion statements. The FDA is taking Novo Nordisk to task for a bunch of problems at a key facility near its Denmark headquarters. Specifically, the agency inspected the plant last year and found employees were wearing goggles that were not sterilized and also had two openings at the […]
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Pharmaceutical Cargo Theft on the Decline
source Those Soprana wanna-bees are having a harder time pulling the proverbial fast one on the pharmaceutical industry. The latest data shows that the average loss of 30 reported cargo thefts of pharmaceuticals last year was $168,219, a huge drop from $550,566 in 2011 and an even more dramatic plunge from $3.78 million that was […]
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More Trouble at Endo?
source As if Endo Health Solutions did not have enough trouble. First, 2013 revenue may not meet earlier projections. A replacement for its retiring ceo has yet to be named. Its biggest shareholder, Fidelity Investments, is pushing for a sale. And now we learn that the FDA was not convinced of the tamper-resistance of its […]
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Zoloft No Better Than Placebo, Claims Suit
source In an unusual gambit, a California woman has filed a lawsuit claiming that the Zoloft antidepressant sold by Pfizer is no more effective than a placebo and that the drugmaker conspired to hide this fact from the medical community and the public in hopes of generating as many sales as possible. For its […]
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Congress to FDA – Cough Up NECC Docs, Or Else
source Nearly four months after the House Energy and Commerce Committee asked the FDA to provide all documentation concerning its oversight of the New England Compounding Center, which was linked to the fungal meningitis outbreak, the agency has yet to deliver the goods. So late last week, the committee threatened to issue a subpoena if […]
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Strong Push for Clinical Trial Disclosure in Europe
source As the debate over clinical trial transparency heats up, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent. And one of her suggestions is already meeting with some resistance […]
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French Government Pulls Bayer Acne Drug Over Deaths
source Two days after launching an investigation into four deaths linked to the Diane-35 acne medicine sold by Bayer, which is also prescribed as a contraceptive, French authorities have halted the sale of the drug. More than 300,000 women are using the drug for contraception, according to the National Agency for the Safety of Drugs […]
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