Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today boasts the aroma of blueberries — and get started. Meanwhile, do keep us in mind if you hear anything interesting. Have a smashing day…
In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs, STAT tells us. Skinny labeling refers to a process in which a generic drug company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug 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. Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines.
The U.S. Food and Drug Administration is on track to make it harder for CAR-T therapy developers to bring their products to market by making full randomized, controlled trials the new standard it will accept for regulatory filings, Pharmaphorum writes. At the moment, it has been possible to develop CAR-Ts based on single-arm trials, although some have used an active comparator. Now, with the number of CAR-Ts on the market now in double figures, the FDA is eyeing RCTs with a control group as well as “a survival or acceptable time-to-event endpoint.” The move towards a higher threshold for showing efficacy for new CAR-Ts comes after the FDA loosened requirements for safety monitoring by eliminating the risk evaluation and mitigation strategies previously required for already-marketed therapies targeting CD19 and BCMA, which the agency said would make them more accessible.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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