Expanding on guidance issued a dozen years ago, the U.S. FDA released a draft guidance to help sponsors developing cancer drugs for use in novel combinations determine the contribution of the individual drugs’ effect.
The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
Carving out $400 million in annual cost savings is going over well with Sarepta Therapeutics Inc.’s investors, as the company’s stock got a 19.6% boost on July 17. Its big seller, the gene therapy Elevidys (delandistrogene moxeparvovec), continued its revenue numbers decline, so Sarepta chopped operating expenses by letting about 500 employees go in a 36% cutback and pared its development path.
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
Amphix Bio LLC has been granted U.S. FDA orphan drug designation for its lead candidate AMFX-200 for the treatment of acute spinal cord injury (SCI). AMFX-200 is an FGFR (fibroblast growth factor receptor) and ITGB1 (integrin β1) agonist peptide amphiphile scaffold. In preclinical models of acute SCI, a single injection of AMFX-200 into the spinal cord enabled motor neurons from the brain to regrow past the injury site.
The U.S. FDA has cleared Genetic Leap’s IND application for GL-IL2-138, a small-molecule RNA drug that modulates natural IL-2, allowing for downregulating or upregulating of the immune system to fight diseases.
Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
For the second time in five years, the Centers for Medicare & Medicaid Services (CMS) has proposed to erase the inpatient-onlylist over a span of three years, stating that physicians are capable of deciding which site of service is best for their patients.
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of pulsed field ablation for atrial fibrillation, and while several trusts in the U.K. are already using these devices for their patients, the endorsement is certain to expand utilization in the U.K., which according to data from Clarivate’s Epidemiology Intelligence may come to nearly 4 million.
A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for sickle cell disease.
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