Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Antengene, Biogen, Braeburn, Janssen, Pfizer, Recce.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Bioxytran, Bloomsbury Genetic, Brim, Cerecin, Emmaus, In8bio, Liscure, Moderna, Molecular Targeting, Numinus, Quralis, Takeda, VBI, Visiox, Y-mabs.
China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascletis, Delta-Fly, Moleculin, Novavax, Oncopeptides, Qualigen, Sionna.
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altrubio, Biocardia, Biogen, Curadev, Ocuphire, Sage, SQZ, Vistagen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Biogen, Hexaell, Ideaya, Idorsia, Pfizer, Protalix, Redhill, Syndax.
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beam, Eqrx, GSK, Hoth, PTC, Rigel, Y-Mabs.
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
RSS
