Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
Centessa Pharmaceuticals plc has obtained IND clearance from the FDA to initiate a phase I study of ORX-142 in healthy volunteers. ORX-142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders.
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
The U.K. Medicines and Healthcare Products Regulatory Agency is reminding industry that several new regulatory requirements are in effect as of June 16, 2025, such as a postmarket surveillance rule that says manufacturers have only 15 days to report serious incidents to the agency.
Calling it “incredible news,” Massachusetts Attorney General Andrea Joy Campbell reported June 16 that U.S. District Judge William Young ordered the Trump administration to restore funding for NIH research grants focusing on gender and diversity, equity and inclusion (DEI).
The COVID-19 pandemic sent the world into a tailspin, raising ongoing concerns about biosecurity, a subject that encompassed the better part of the morning June 16, the first day of the Biotechnology Innovation Organization’s annual conference in Boston.
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene moxeparvovec), cleared for Duchenne muscular dystrophy (DMD). Shares of Cambridge, Mass.-based Sarepta (NASDAQ:SRPT) closed June 16 at $20.94, down $15.24, or 42%, as Wall Street digested the news.
Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.
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