The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.
Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.
The urgency behind Diplomat's launch of its Retail Specialty Network isn't hard to fathom. As the growth momentum in pharmaceuticals shifts from traditionally developed drugs to more complex and expensive specialty and biotech products, traditional pharmacies without access to these specialized medicines — and the patients who depend on them — find themselves stranded in a receding market like boats at low tide.
While rates of human papillomavirus infection among girls ages 14 years to 19 years have dropped by half since the Centers for Disease Control and Prevention started recommending routine vaccination against it seven years ago, rates of vaccination have not increased, the agency said.
A new track-and-trace bill that the Senate is expected to consider would institute a nationwide "track-and-trace" system in place of patchwork state laws with the aim of securing the pharmaceutical supply chain.
A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.
Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.