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While the study hit its primary efficacy endpoints, investors are likely concerned about reports of “inconsistent results” regarding reducing Uox excretion in a subtype of patients with the rare disease.
CytoDyn files a lawsuit against the activist group led by Rosenbaum and Patterson, alleging that they are “waging an illegal proxy contest to take over control of the Company’s Board of Directors.”
The announcement for the chikungunya vaccine (VLA1553) comes after the U.S. FDA awarded it with a Breakthrough Designation status. Read more about it here.
Eisai said that they have initiated communication with the FDA to achieve “the most optimal regulatory pathway” for lecanemab.
Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients, issues that may compromise the safety of the firm’s manufactured drugs.
Schrödinger and Zai Lab have announced a worldwide development and commercialization collaboration to advance a novel oncology program targeting the DNA damage repair pathway.
Biosimilars have gained traction in Europe, but not in the U.S. AbbVie’s Humira is often made as an example of how companies are using legal tactics to delay biosimilar competition.
Pfizer said that the Phase IIb/III ALLEGRO trial on ritlecitinib was found to be effective against the autoimmune disease, which is characterized by an immune attack on hair follicles.
The FDA-initiated partial hold on Novartis’ gene therapy trial for spinal muscular atrophy has been lifted recently. Here’s everything you need to know about it.
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