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.
The board of General Electric Co. officially approved the tax-free spin-off of the company’s health care business, which will be called GE Healthcare Technologies Inc. The new company will begin trading on the Nasdaq on Jan. 4, 2023, under the ticker symbol “GEHC.”
The ability to inexpensively predict events such as stroke and heart attack is something of a holy grail for cardiologists, and a new study presented at this year’s annual meeting of the Radiological Society of North American (RSNA) provides just that capability. A study of an algorithm developed to examine a single chest X-ray suggests that the data generated by the algorithm can be as effective in establishing the patient’s risk of these events as a standard approach that relies on information that isn’t always readily available to the clinician.
The U.S. FDA has approved its first fecal microbiota treatment. Rebyota (fecal microbiota, live-jslm), from privately held Ferring Pharmaceuticals Inc., is now approved to prevent recurring Clostridioides difficile infection (CDI) in adults. The Nov. 30 approval came about two months after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 13-4 to support the microbiome therapy’s effectiveness in reducing recurrent CDI in adults after antibiotic treatment for recurrent CDI.
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.
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.
The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
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.
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.
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