Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023. Based on the trial results, CSL will file global regulatory submissions later in 2023. A humanized anti-factor XIIa monoclonal antibody, garadacimab is self-administered by subcutaneous administration once monthly, which is a huge convenience for patients, Andrew Nash, CSL’s chief scientific officer and senior vice president for research, told BioWorld.
Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023.
Radiopharmaceutical company Fusion Pharmaceuticals Inc. is acquiring a phase II actinium-based alpha-emitter radiopharma program for prostate cancer from Radiomedix Inc.
South Korean biotech peers Celltrion Healthcare Co. Ltd. and Liscure Biosciences Co. Ltd. signed a deal to co-develop microbiome-based oral live biotherapeutic products for Parkinson's disease. Under the agreement, Celltrion, of Incheon, South Korea, will provide Seoul-based Liscure with research funding as well as additional payments as the project progresses. Liscure will lead discovery of the novel candidates, and Celltrion will be responsible for further clinical and regulatory development.
Bridge Biotherapeutics Inc.’s small-molecule Pellino-1 inhibitor, BBT-401, failed to meet the primary efficacy endpoint in a phase II trial in ulcerative colitis (UC). The phase II mid-to-high dose cohort study included 38 patients with active UC enrolled at 37 clinical sites across the U.S., New Zealand, South Korea, Poland and Ukraine.
One of the most important transformations in the pharmaceutical industry over the next decade is the ability to modify genes or expression and go after any target, Cargene Biopharma Inc. CEO Kathy He told BioWorld, explaining that small molecules and large molecules can only go after 15% of the known targets. But the technology platform of short-interfering RNA (siRNA) opens a huge opportunity to make those inaccessible targets available, she said.
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.
One of the most important transformations in the pharmaceutical industry over the next decade is the ability to modify genes or expression and go after any target, Cargene Biopharma Inc. CEO Kathy He told BioWorld, explaining that small molecules and large molecules can only go after 15% of the known targets. But the technology platform of short-interfering RNA (siRNA) opens a huge opportunity to make those inaccessible targets available, she said.
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.
Medicinal cannabis company Zelira Therapeutics Ltd. secured $8.6 million in cornerstone funding from U.S.-based Cantheon Capital LLC that will progress Zelira’s Hope1 cannabinoid medicine to formal phase II/III clinical trials for behaviors associated with autism spectrum disorder.
