The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose.
After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt.
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accure Acne.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Caribou, Clarity, Genmab, Immorna, Legend, Okyo, Rhythm, Tetra, Triastek.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bioinvent, Carmell, Eli Lilly, Emmaus, Iovance, Iveric, Kempharm, Novavax, Provention, Sanofi.
The U.S. FDA has finalized a rewritten draft guidance for Section 522 postmarket surveillance studies, a policy that carries a new level of stringency regarding how these studies are conducted. The final guidance calls for all subjects in such a study to be enrolled within 24 months, a deadline some in industry argued might prove unduly burdensome in some instances.
Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc Medical.
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