Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).
Gracell Biotechnologies Inc. stands to gain up to $150 million from an assorted bouquet of private U.S. health care investors to lay a solid foundation for clinical trials of its leading dual-targeting CAR T-cell candidate, GC-012F, and provide a cash runway into the second half of 2026.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).
Amarin Corp. plc has chosen Taiwan-based Lotus Pharmaceutical Co. Ltd. to make headway in Southeast Asia and South Korea for omega-3 fatty acid-based Vazkepa, its icosapent ethyl drug that’s facing increasing generic and pricing pressure in the U.S. and Europe.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial.
Viage Therapeutics Inc. – formerly Digestome Therapeutics Inc. – on July 26 unveiled positive data from its phase I study on DGX-001 for mild cognitive impairment in Alzheimer’s disease (AD) and Parkinson’s (PD). The randomized, double-blind, placebo-controlled study demonstrated changes in brain activity according to quantitative electroencephalography (qEEG) measurements in 68 healthy volunteers dosed with single ascending and multiple ascending doses.
Japanese pharmaceutical company Astellas Pharma Inc. is scouting for more novel targeted protein degrader (TPD) therapeutics, having added a research and licensing deal with Peptidream Inc. to its shopping cart filled with TPD promises.
