Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
The U.S. Court of Appeals for the Federal Circuit has upheld a district court decision that Natera Inc. is entitled to an injunction of a Neogenomics Inc. assay for detection of circulating tumor DNA (ctDNA). This outcome serves as a sobering reminder that injunction can be obtained at the preliminary injunction stage by demonstrating that an effort to prove infringement is likely to succeed even in the absence of a thorough evaluation of the contested claims in that patent.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
Artelo Biosciences Inc.’s IND application for ART-26.12, for the treatment of chemotherapy-induced peripheral neuropathy, has been granted clearance by the FDA allowing the company to initiate a first-in-human phase I study. Results are expected in the first half of next year.
A bipartisan bill aimed at limiting patent thickets on biologics moved a step closer to law July 11 when the Senate passed it with unanimous consent in an unexpected vote that came more than one-and-a-half years after the Judiciary Committee reported it favorably to the Senate floor. The Affordable Prescriptions for Patients Act, S. 150, which would limit the type and number of patents that can be litigated under the Biologics Price Competition and Innovation Act (BPCIA), now awaits House action.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike. The outpatient draft for CY 2025 tackles the implications of some new technologies for the pass-through payment program, but nestled in the draft rule is a proposal to pay separately for diagnostic radiopharmaceuticals.
A committee of the U.S. House of Representatives proposed an FDA discretionary spending bill of less than $26 billion in appropriated taxpayer dollars for fiscal year 2025.
The U.S. FDA’s final guidance for device-based treatments for opioid use disorder breaks little new ground relative to the 2023 draft, including a call for the use of a randomized, controlled clinical trial that retains blinding of not just enrollees, but also of the clinicians taking part in these studies.
Rznomics Inc. has received clinical trial notification (CTN) from Australia’s Therapeutic Goods Administration (TGA) for the initiation of a phase I/IIa trial evaluating RZ-004, a gene therapeutic candidate for autosomal dominant retinitis pigmentosa with rhodopsin mutation.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike.
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