The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
LONDON – Swedish researchers have devised a method for binding insoluble antibiotics to graphene coatings, in an advance that could prevent the formation of biofilms on medical implants. In comparison to other long-winded methods for loading antibiotics onto implant surfaces, they say the way in which they bind active molecules to graphene is simple and could easily be integrated into manufacturing processes.
The U.S. Court of Appeals for the Seventh Circuit has affirmed an injunction obtained by Life Spine Inc. against L&K Biomed for the latter’s alleged appropriation of trade secrets obtained by an L&K subsidiary. The outcome affirms that injunctive relief is available to plaintiffs when irreparable harm is plausibly alleged, but also highlights the need for internal controls to avoid accidental use of trade secrets during product development programs.
Continuing its push to streamline the imaging industry from equipment to vertical integration, Nano-x Imaging Ltd. (Nanox) agreed to acquire Zebra Medical Vision Ltd. and signed a letter of intent to buy Usarad Holding Inc. and its related company Medical Diagnostics Web. The timing of the transactions, designed to create an end-to-end radiology solution, was not announced.
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise.
The European Commission’s Medical Device Coordination Group has posted several guidances for unique device identifiers (UDIs), the most recent of which is related to a company’s quality management system. While most regulators have developed policies related to UDIs, this MDCG guidance recommends that device makers formally incorporate those requirements into their QMS programs, and that notified bodies will examine the manufacturer’s compliance with these requirements during inspections.
LONDON – Birmingham University spinout 4D Biomaterials Ltd. has raised initial funding of £1.6 million (US$2.2 million) to commercialize a new shape-changing biopolymer for use in soft tissue repair.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
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