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 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 FDA has awarded orphan drug designation to Cure Rare Disease’s CRD-003 for the treatment of limb-girdle muscular dystrophy type R9 (LGMD2i/R9), a congenital muscular dystrophy caused by biallelic mutations in the FKRP gene.
Resvita Bio Inc. has held a pre-IND meeting with the FDA for RVB-003, its lead investigational therapy for Netherton syndrome. The FDA’s feedback gives the company a pathway to submit an IND for RVB-003 in the first half of next year, with a clinical efficacy read-out anticipated by early 2027.
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.
Amyotrophic lateral sclerosis (ALS), formerly known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder with no known cure. While three therapies have gained U.S. FDA approvals to date, including Rilutek (riluzole), Radicava/Radicava ORS (edaravone) and tofersen (BIIB-067, the lack of a disease-modifying drug has spurred the continual search for novel therapies.
The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.
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