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Cereno's PAH drug got FDA Fast Track. Novo plant cited for contamination. Gilead's HIV PrEP approved in EU. Nelson Labs expanded testing.
In this first installment of a new PharmTech feature, we’ll highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.
Our news stories from this week collectively discuss significant developments in the pharmaceutical industry, highlighting both advancements in drug therapies and critical manufacturing challenges. We detail Cereno Scientific's PAH treatment receiving FDA fast-track status due to promising trial results, indicating accelerated development for a much-needed therapy. We also report that Gilead Sciences' HIV PrEP injectable gained European Commission approval, offering a novel, less frequent dosing option for HIV prevention. In contrast to these positive strides, we revealed this week that an FDA inspection uncovered serious contamination and safety issues at a Novo Nordisk plant, raising concerns about quality control in drug manufacturing. Finally, we highlighted Nelson Labs' expansion of its German and US facilities, signifying a growing demand for enhanced laboratory and sterility assurance services within the pharmaceutical sector.
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