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.
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.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Biomind Everest, Immunogen, Junshi, Kineta, Neurosense, Zielbio, Zynerba.
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.
China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy.
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