Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.
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Immunology & inflammation stole the show this week, as Gilead dropped up to $2.1 billion for Ouro Medicines and its T cell engager OM336—an investment it hopes to split with longtime partner Galapagos. Meanwhile, Sanofi also added a T cell engager in a licensing deal with Kali Therapeutics worth $180 million upfront.
One I&I partnership that bore fruit last week was that of Johnson & Johnson and Protagonist Therapeutics which got their IL-23 receptor blocker Icotyde across the FDA finish line for plaque psoriasis. Icotyde is the first commercial product for Protagonist.
Even the drama this week came from the I&I space, as Kevin Tang took the reins as CEO of Aurinia Pharmaceuticals, which you may remember was the company at the heart of former Center for Drug Evaluation and Research Director George Tidmarsh’s exit from the FDA.
Outside of I&I, the CDC’s Advisory Committee on Immunization Practices made headlines once again as Vice Chair Robert Malone posted to social media that the group was being disbanded. The Department of Health and Human Services quickly corrected the record, but Malone posted a few hours later that “dissolving and reforming remains one of options being considered.”
In FDA policy news, BioSpace recaps the now nine-month-old Commissioner’s National Priority Voucher pilot program and unpacks new draft guidance on animal testing alternatives. Plus, check out an opinion article on the need for precision ALS drugs and features on gene therapy for hearing loss and Big Pharma’s overall R&D spending in 2025.
