As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
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There was a high point this week for employees riding the rollercoaster that is currently the FDA, as 300 recently fired employees are reportedly being asked to return. This could serve to boost spirits at the agency, which is reeling from unpredictable and seemingly ‘indiscriminate’ layoffs—and low morale as a result.
Trump made additional waves over the weekend, threatening to enact tariffs on the largest pharmaceutical companies—unless they relocate their manufacturing operations to the U.S. And the early impacts of the new administration continue to be felt, as the CDC’s vaccine advisory board postponed its first meeting of 2025—just a week after RFK Jr.’s confirmation as HHS secretary.
In weight loss news, the Outsourcing Facilities Association (OFA), which represents compounders, is suing the FDA after the agency declared an end to the shortage of semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy. This followed a similar OFA lawsuit last fall, filed after the FDA removed Eli Lilly’s tirzepatide— Zepbound and Mounjaro—from its shortage list. In a possible attempt to protect Zepbound from compounder competition, Lilly announced Tuesday that it will expand single dose vials options of the blockbuster weight loss drug at a reduced price. This all comes as a new study compares physician wishlists with investment in the obesity space—and reveals key indicators for drug developers.
And it’s been a good news/bad news kind of week in gene therapy, as Pfizer discontinued hemophilia B drug Beqvez worldwide, Regeneron reported more positive data from its gene therapy for genetic deafness and, facing a cash crunch, bluebird bio elected to go private in an acquisition by global investment firms Carlyle and SK Capital Partners.
Finally, let us leave you with a ghost story—the story of so-called “ghost assets” that have found a new home, and a new purpose.
