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.
Rigel Pharmaceuticals Inc.’s ahead-of-deadline approval from the U.S. FDA of Rezlidhia (olutasidenib) twice-daily capsules for adults with relapsed/refractory (r/r) acute myeloid leukemia (AML) came as a surprise to the company, but followed encouraging interactions, “including a very positive midcycle review meeting,” said CEO Raul Rodriguez, adding that the firm will “redouble our efforts to make sure we're able to convey the information supporting this product” to the marketplace. Regulators had assigned the compound a Feb. 15, 2023, PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Aurinia, Bluejay, Citius, Eli Lilly, Ferring, Innoviva, Nuvectis, Oncolytics, Opus Genetics, Orchard, Pyxis, Scynexis, Sparingvision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ananda, Aum, First Wave, Lobe, Nova Mentis, Regeneron, Sensorion, Transcode, Vistagen.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product.
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