Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
After nearly a decade and a half of service at the U.S. FDA, Bill Maisel will retire from the agency, taking with him a wealth of experience as both a physician and a regulator. The agency said Owen Faris, also a long-time member of the FDA staff, will take Maisel’s place as the director of the Office of Product Evaluation and Quality (OPEQ), but this is a temporary stint for Faris as the agency will conduct a search for Maisel’s replacement.
Reprieve Cardiovascular Inc. landed $42 million in its first fundraising round out of stealth to fund development of its acute decompensated heart failure treatment. The series A round will support clinical and development programs, including the ongoing FASTR trial and Reprieve’s upcoming pivotal trial.
Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
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