Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analysis of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Arcellx, Biogen, Bioinvent, Bluerock, ERC, Fibrogen, Eli Lilly, Incyte, Pfizer.
The latest global regulatory news, changes and updates affecting biopharma, including: EC provides emergency funding for COVID-19 research; Final judgment against former Retrophin attorney; FDA hits company for deviations from drug, device GMPs.
Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes.
Vysioneer Inc. has won the FDA’s nod for its Vbrain artificial intelligence (AI)-powered tumor autocontouring software. The company said Vbrain is the first AI device to receive FDA clearance for tumor autocontouring in radiation therapy. Vbrain is a neural network-based AI solution, trained from clinical data.
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
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