Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because the usual routine of online meetings, phone calls, and deadlines has inevitably returned. But you knew this would happen, yes? After all, what can you do? The world, such as it is, continues to spin. So in hopes of nudging it in a better direction, we are brewing cups of stimulation. Our choice today is hazelnut mocha. Meanwhile, here are a few items of interest. We hope your day is meaningful and productive. And by the way, do take care if an eclipse passes by. …
After years of back-and-forth deliberations, the U.S. Food and Drug Administration agreed to review an application for a rare disease drug developed by a small company that planned to shelve further work if the agency did not take this long-sought step, STAT says. The FDA will also hold an advisory committee meeting. The move comes after Stealth BioTherapeutics spent the past decade developing and testing its drug in hopes of winning approval for a tiny population numbering only 130 to 150 patients around the country. But the company had a difficult time navigating regulatory bureaucracy and came to symbolize the challenges of winning regulatory approval for such treatments.
Five months after setting out a controversial new vision, Sanofi has informed employees some will lose their jobs as a result, Fierce Biotech reports. About 230 words into what appeared to be an inspiring email setting out Sanofi’s ambitions — to build “an immunoscience powerhouse, set to accelerate launches and transform the practice of medicine”— Houman Ashrafian, who heads R&D, wrote about “a simplified R&D structure” and layoffs. In the April 4 email, he said the decision followed “an extensive review” conducted in coordination with leaders across the organization including in R&D, commercial “and beyond.” The result is a “full pipeline reprioritization project.”
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