Former FDA Commish: Bayer Hid Yasmin Data
On the eve of an FDA advisory committee meeting being held to review the risks and benefits of various birth control meds – notably the Yaz and Yasmin pills sold by Bayer – newly unsealed documents in the sprawling litigation involving the Bayer drugs show that former FDA commish David Kessler offered a scathing expert […]
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Glaxo Scientists ‘Live or Die’ With Project in Research Overhaul
Six months ago, Roberto Solari talked eagerly about his research into the mechanisms that govern asthma. Now he must let someone else finish the job. Solari, who until last month headed one of GlaxoSmithKline Plc (SAN)’s targeted research units, is one of the casualties of the company’s new approach to drug discovery. Glaxo is conducting […]
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Botox maker Allergan sued by Las Vegas surgeon
A Las Vegas plastic surgeon has sued Allergan Inc., accusing the Irvine pharmaceutical company of selling its popular wrinkle treatment Botox in large vials and encouraging physicians to unsafely reuse them. Dr. Julio L. Garcia contends that Allergan sold Botox exclusively in 100-unit vials for several years, even though a typical treatment required just 20 […]
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Will Hospira Get A Consent Decree?
As prescription drug shortages abound, one of the manufacturers that has contributed significantly to the problem appears increasingly likely to get hit with a consent decree by the FDA, at least according to one Wall Street analyst, who believes the ongoing manufacturing problems are much worse than anyone previously thought. In an investor note, RBC […]
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Russian Trial Rules Are A ‘Serious Blow’ To Pharma
There is nothing like a protectionist policy to slow things down. Take the Ethics Council at the Ministry of Healthcare and Social Development in Russia, which required drug sponsors to conduct local registration trials. Rather than provide a boost, the regulation “has become the most serious blow to the system governing the access of new […]
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We Don’t Need No Stinking Side Effects Reporting System!
So here is an interesting way to interpret FDA regs – if no adverse events are reported for your drug, why bother instituting procedures for tracking and reporting any side effects? This may not make sense to everyone, but that was apparently the rule of thumb that was followed by Crescendo Therapeutics, which sells HybriSil, […]
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Three hurt in fire at Indian pharma plant
A tense situation prevailed for some time on the premises of Aurobindo pharmaceutical unit at Pydibheemavaram in Ranasthalam mandal in the district when three workers of the plant were injured in a fire mishap that occurred inside the plant in the early hours of Monday. On being informed, police, revenue, fire and media reached the […]
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FDA, Adulterated Drugs And Industry Silence
The various scandals involving adulterated drugs and pet food in recent years prompted some members of Congress to ask the US General Accountability Office to review how the FDA oversees product safety to prevent and respond to economic adulteration. Not surprisingly, the GAO found that the increasing complexities of the global supply chain pose significant […]
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FDA Tries To Shut Dietary Supplement Maker
On the eve of the Thanksgiving holiday in the US, the FDA waded into the controversy over dietary supplement makers by filing a permanent injunction against a manufacturer, ATF Fitness Products and two related entities, for substituting ingredients and products without noting any changes on final product labeling. The move would stop ATF and its […]
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More Children Skipping Vaccines In Some States
To vaccinate or not to vaccinate? That is a question that continues to concern parents nationwide. And a new analysis found that, in eight US states, more than 1 in 20 public school kindergartners are not receiving all the vaccines required for school attendance. And in more than half of all states, there has also […]
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