ood morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because the familiar routine has now returned. One consolation — at least for those of you toiling in the same region as the Pharmalot campus — is simply beautiful weather today. So after you finish gazing out the window, here are some tidbits to help you along. Hope your day goes well and remember to keep in touch …
Despite being alerted by its own sales team, Purdue Pharma failed to inform authorities about an extremely high number of OxyContin prescriptions that were written and filled in California several years ago, the Los Angeles Times reports. By the time the drug maker took action, a medical clinic involved in the activity was out of business and its leaders indicted — and 1.1 million pills made their way to gangs and mobsters.
Amgen’s biosimilar version of Humira, a blockbuster drug sold by AbbVie, is similarly safe and effective as the original treatment, according to a review by US Food and Drug Administration staffers. An FDA advisory panel is scheduled to meet Tuesday to decide whether to recommend approval of the Amgen version. Humira is used to treat several forms of arthritis, Crohn’s disease, psoriasis, ulcerative colitis, and ankylosing spondylitis.
Theranos chief executive Elizabeth Holmes, who recently abandoned her uniform of black turtlenecks, has continued to put a positive spin on her beleaguered blood-testing company, the Wall Street Journal reports. At the same time, Holmes has kept employees in the dark on many issues. She recently told them the company developed 304 tests, but not that most of the experiments had not yet progressed beyond laboratory research.
Pfizer reported that taking its Sutent treatment once a day for a year after surgery for kidney cancer significantly improved progression-free survival versus a placebo in a late-stage trial, Pharma Times reports. Until now, no targeted therapy has proven effective in such a setting. Full results were not yet reported, but the findings come as Pfizer gears up to thwart competition from Exelixis and Bristol-Myers Squibb.
The FDA released draft guidance describing the process that generic drug makers must follow when they have to update a product label after the brand-name medicine is withdrawn for reasons not related to safety or effectiveness, Regulatory Focus writes. The move underscores concerns that arise when a brand-name drug is withdrawn for any number of different commercial reasons.
The FDA says it met its goal of taking regulatory action on 90 percent of generic drug applications as required by law more than a year ahead of its mandated schedule.
The FDA approved an expanded age range for Novartis and Genentech’s Xolair to include younger children with moderate to severe persistent asthma, Pharma Times writes.