A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the new therapy approved for Americans with HES in nearly 14 years, according to the FDA. An EMA filing in HES is expected later this year.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.
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