Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
Centricity Vision Inc. received U.S. FDA clearance for technology designed to integrate with modern phacoemulsification or “phaco” systems that use ultrasound energy to emulsify the eye's native internal lens during cataract surgery. Centricity’s new Zeptolink interocular lens (IOL) positioning system is used in conjunction with phaco systems to surgically remove the natural lens of the eye as the first step in cataract surgery.
Most of the decisions arising from the inter partes review (IPR) process used in the U.S. patent system are the final word on the related patent dispute, but Guardant Health Inc., managed to at least temporarily reverse such an outcome recently. The Court of Appeals for the Federal Circuit reversed an IPR determination that 16 claims found in a patent held by Guardant were obvious and kicked the case back to the Patent Trial and Appeal Board (PTAB) for further consideration, but the affected patent is not clear of an adverse determination just yet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Invivoscribe.
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress.
A day after grilling top executives from the three largest pharmacy benefit managers (PBMs) in the U.S. about their business practices and the impact they have on prescription drug prices, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 18-3 May 11 to favorably report the bipartisan PBM Reform Act to the full Senate.
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved.
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11.
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
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