STAT+: Pharmalittle: We’re reading about another FDA reversal, pharma’s M&A spree and much more

Good morning, everyone, and welcome to another working week. We hope the weekend respite — longer than usual thanks to a holiday on this side of the pond — was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is English breakfast. Feel free to join us. Remember, no prescription is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals and we hope you conquer the world. And, of course, do keep in touch … The U.S. Food and Drug Administration will reconsider approving an experimental gene therapy for a deadly and rare childhood brain disorder that it rejected just four months ago, STAT tells us. The sudden turnaround is the latest in a series of apparent FDA reversals in the past two months, after leaders installed by the Trump administration resigned or were fired. Just last week, UniQure announced it was cleared to submit an application for a Huntington’s disease gene therapy that the agency had previously spurned and that former commissioner Marty Makary appeared to disparage on national television. The U.S. launched a trade investigation into a German plan to lower its spending ​on pharmaceutical products, to see whether it is unreasonable or ‌discriminatory, Reuters notes. The probe by the U.S. Trade Representative comes under Section 301 of the Trade Act of 1974 and follows a move by the German Ministry of Health unveiled plans in April for a ​wide-ranging overhaul of the country’s statutory healthcare system to reduce a looming funding gap ‌by $23 billion. The plan, which would have introduced variable discounts on pharmaceuticals, is being replaced after the pharmaceutical industry expressed opposition to it.Continue to STAT+ to read the full