The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Researchers from the U.K. have analyzed whole-genome sequencing data from 7,276 cases and 236,741 controls in the UK Biobank to perform gene-level and a variant-level exome-wide association study analysis to identify variants related to retinal detachment.
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15.
WDR45 is located on the X chromosome. Its pathogenic variants are associated with various neurodegenerative disorders that are predominantly reported in females and present a wide range of clinical phenotypes, from early-onset developmental delay to neurodegeneration and multiple epileptic syndromes.
Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with normal, healthy genes to restore cellular function.
Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with normal, healthy genes to restore cellular function.
Allovir Inc., which has struggled since late last December, will merge with privately held Kalaris Therapeutics Inc. to develop therapies for treating neovascular and exudative retinal diseases. Kalaris already has an anti-VEGF treatment in a phase I study with a data readout set for the third quarter of 2025. Once the deal closes, the combined company name will be Kalaris Therapeutics Inc. and shares will trade on Nasdaq as KLRS. The new company said it plans to drive development of TH-103 for treating neovascular age-related macular degeneration (nAMD), diabetic macular edema and retinal vein occlusion. The phase I study is for treatment of nAMD.
Retinitis pigmentosa (RP) is the most common hereditary degenerative eye disease that leads to progressive vision loss, primarily caused by retinal degeneration.
Ring Therapeutics Inc. has joined forces with Singapore’s Agency for Science, Technology, and Research and with the Singapore Eye Research Institute to advance the first new class of viral vectors in more than 50 years, Ring CEO Tuyen Ong told BioWorld.
The nearer-looming threat of a biosimilar from Amgen Inc. to heavyweight Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) VEGF therapy, Eylea (aflibercept), along with other issues, pressured shares of the latter (NASDAQ:REGN) since reporting third-quarter earnings Oct 31. But Wall Street pundits are not altogether aligned on how serious the scenario might be. After the earnings update, Regeneron’s stock fell 12%, from $925 to $819.96, and closed Nov. 1 at $843.60, up $5.40.
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