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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ascletis, Buchang, Capstone, Caribou, Genentech, Gilead, Kala, Novavax, Remd, Sofie.
The U.K. Bioindustry Association (BIA) is in an eleventh hour fight against changes to R&D tax breaks that it estimates will result in a £400 million to £800 million (US$480 million to $960 million) cut in payments to the sector. The changes will see cash credit claims reduced from 14.5% to 10%, cutting payments from 33 pence per £1 of spend to 18.6 pence per pound of spend from April 2023. Along with other tweaks, this is an effective 50% cut for biopharmas that do not pay any corporation tax because they are loss-making.
As the days have grown darker throughout November, global regulatory activity and U.S. approvals have continued to drop, marking the month as the slowest of 2022. Compared with this time last year, regulatory news is down by 9% and FDA approvals are down by a quarter. On top of that, new molecular entity clearances in the U.S. are at a six-year low.
Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval.
With only a year to go before 100% compliance with the U.S. Drug Supply Chain Security Act’s serialization provisions will be required from the beginning to the end of the drug supply chain, most biopharma manufacturers are pretty confident they’re ready for the Nov. 27, 2023, deadline. But distributors? Not so much. And they lay the blame at the manufacturers’ feet.
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