The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) Tuesday reported that it gave its first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the use of Gilead Sciences Inc.’s remdesivir to treat adults and adolescents hospitalized with severe COVID-19 who meet additional clinical criteria. Use of the drug is to be determined by a physician through the EAMS, where it will be provided to the National Health Service free of charge by Gilead throughout the EAMS period. Remdesivir also will continue to be used in clinical trials, several of which already have been approved by the MHRA and are ongoing in the U.K.
The Institute for Clinical and Economic Review (ICER) Tuesday released a draft evidence report assessing the comparative clinical effectiveness and value of treatments, including marketed biosimilars, for ulcerative colitis (UC). The report assessed Abbvie Inc.’s Humira (adalimumab); Johnson & Johnson’s (J&J) Simponi (golimumab); J&J’s Remicade (infliximab); Pfizer Inc.’s Inflectra; and Merck & Co. Inc.’s Renflexis, biosimilars to Remicade; Pfizer’s Xeljanz (tofacitinib); J&J’s Stelara (ustekinumab); and Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab). Comments on the draft should be submitted by July 29, 2020. The report will be discussed Sept. 24 at a meeting of the California Technology Assessment Forum.
Janet Woodcock, who has headed the FDA’s Center for Drug Evaluation and Research (CDER) for several years, is shifting roles to focus on the development of COVID-19 treatments. FDA Commissioner Stephen Hahn tweeted Friday that Woodcock would temporarily move to the Office of the Commissioner to work on Operation Warp Speed's COVID-19 therapeutics initiative. During that time, Patrizia Cavazzoni will serve as acting director of CDER. Woodcock's "work will complement FDA's Coronavirus Treatment Acceleration Program, which is using every tool [at] our disposal to bring new therapies to sick patients as quickly as possible, while also supporting research to further evaluate these medical countermeasures," Hahn said. Citing the “team of tremendous experts in vaccine development that’s been assembled to pursue Operation Warp Speed,” Hahn also announced that Peter Marks is stepping away from the project to focus on his duties as director of the agency’s Center for Biologics Evaluation and Research, where he will lead the center’s spectrum of coronavirus work being done in both the vaccine and therapeutic space.
The U.S. Patent and Trademark Office is proposing changes to the rules of practice for the Patent Trial and Appeal Board (PTAB), implementing the Supreme Court’s 2018 ruling in SAS Institute Inc. v. Iancu. In that 5-4 decision, the court held that the America Invents Act requires the PTAB to decide the patentability of all claims challenged in an inter partes review (IPR) that's instituted instead of the pick-and-choose policy the board had been following. Under the proposed rule change, if the PTAB institutes an IPR, post-grant review or transitional program for covered business method patents proceedings, the trial will proceed on all challenged claims and all grounds of unpatentability. Another proposed change would eliminate the presumption that a genuine issue of material fact created by a patent owner’s testimonial evidence filed with a preliminary response will be viewed in the light most favorable to the petitioner for purposes of deciding whether to institute a review. Instead, such testimony will be considered part of the totality of the evidence. Comments on the proposed rule changes are due by June 26.
The FDA Tuesday released a draft guidance for determining new permitted daily exposures for three residual solvents – 2-methyltetrahydrofuran, cyclopentyl methyl ether and tert-butyl alcohol. The International Council for Harmonisation guidance recommends acceptable amounts of the listed residual solvents in pharmaceuticals to ensure the safety of patients. Comments should be submitted to Docket No. FDA-2020-D-1301.