Hello, everyone, and how are you today? We are doing just fine, thank you, despite the steamy heat surrounding the Pharmalot campus. Our formula for keeping cool is to turn up the cooling machine and keep some cold cups of stimulation at hand. After all, there is much to be done. On that note, let us proceed. Here is the usual menu of interesting items to help you along. Hope your day is productive and try not to sweat …
ClinicalTrials.gov does not require trial sponsors to disclose charges to patients and critics say this allows the site to become a marketing tool for pay-to-play research, Kaiser Health News reports. “If you’re going to be charging patients for the opportunity to be involved in the study, they should not be allowed to be listed … or at least the cost should be listed on the site,” says Alison Bateman-House, a postdoctoral fellow in medical ethics at the New York University School of Medicine.
BioMarin released additional evidence supporting its gene therapy for restoring the blood-clotting ability of patients with hemophilia A, TheStreet tells us. The company now says it will start another study that could be used to get the treatment approved by regulators in the US and Europe. If the treatment is approved, the drug would be the first gene therapy used to treat — and potentially cure — patients with hemophilia A.
FDA has been repeatedly asked to develop guidelines for removal of boxed warnings. They erred by removing the box for Avandia without a guidance in place, and Avandia turned out to be one of the most dangerous drugs ever marketed. Don’t think they will make same mistake with Chantix.
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