Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
The winding regulatory road for the BLA to Capricor Therapeutics Inc.’s cell therapy for Duchenne muscular dystrophy has more clarity. Out of a recent type A meeting between Capricor and the U.S. FDA, prompted by a complete response letter in July regarding lead asset CAP-1002 (deramiocel), the two are in agreement about a path to potential approval.
The struggle to avoid a partial U.S. government shutdown at midnight Sept. 30 is getting a lot of attention, as the stakes increase every day of the political standoff. Meanwhile, Sept. 30 also could be the end of the 43-year-old Small Business Innovation Research (SBIR) program, which has been a funding boon for biotech and med-tech startups, if Congress can’t come together on a reauthorization bill.
Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants.
Billiontoone Inc.’s Unity Fetal Risk screen identifies fetuses at high risk for cystic fibrosis (CF), a study published in Journal of Cystic Fibrosis found.
Heartflow Inc. hasn’t skipped a beat in pumping out good news, with U.S. FDA 510(k) clearance for its next-gen plaque analysis algorithm and platform and Cigna coverage across all lines of coverage starting in October. The new algorithm improves plaque detection 21% compared to the first version of Heartflow’s algorithm.
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