SCOTUS hears skinny label case, AZ expanding in U.K.| STAT

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus, but our spirits remain sunny, nonetheless. And why not? As the Morning Mayor suggested to us long ago, “Every day should be unwrapped like a precious gift.” While you tug on the ribbon, we will fire up the trusty kettle for a cuppa elderberry hibiscus. Of course, you are invited to join us. Remember, no prescription is required. This is strictly cash money. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

AstraZeneca will resume expansion of its research and development operations in a Cambridge, U.K. facility, the first such project to be revived following the trade deal with the U.S. that included measures to lift U.K. spending on medicines, The Financial Times writes. Pascal Soriot, AstraZeneca’s chief executive, said on Wednesday that the drugmaker would invest $400 million to complete the Rosalind Franklin building that it put on hold last year, and build a new laboratory in the town of Macclesfield that would use “digital and data tools to advance drug development.” The company was one of several drugmakers that postponed or cancelled U.K. investments over disagreements with the government about increased medicines spending. As part of a trade deal agreed with the Trump administration, the U.K. agreed to lift the thresholds it uses to determine whether medicines are cost-effective for use on the National Health Service.

After months of anticipation, U.S. Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver, STAT explains. At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement. The court heard arguments concerning a case involving Amarin, which markets a drug called Vascepa for treating different heart problems, and Hikma Pharmaceuticals, one of the largest generic manufacturers.