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, said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well.
The U.S. FDA gave its go-ahead for Hemgenix (etranacogene dezaparvovec-drlb), Uniqure NV’s one-time gene therapy – the first for the treatment of adults 18 and older living with hemophilia B. Patients have been waiting “maybe beyond two decades” for a new therapy, Uniqure CEO Matthew Kapusta said. Hemgenix emerged from pioneering work by St. Jude Children’s Research Hospital and the University College London.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Argenx, Gamida, GSK, Innocare, Intelgenx, Junshi, Marker, Palisade, Regeneron, Revive, Takeda.
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.
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.
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 drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ardelyx, Ascletis, Beigene, PTC, Skye.
With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Ascletis, Canbridge, Depymed, Neurosense.
RSS
