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.
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
Scientists at the University of Sydney have discovered a protein in the lung that blocks SARS-CoV-2 infection and forms a natural protective barrier in the human body. Leucine-rich repeat-containing protein 15 (LRRC15) is an inbuilt receptor that binds the SARS-CoV-2 virus without passing on the infection. The discovery opens a new area of immunology research around LRRC15 and suggests a pathway to develop new drugs to prevent viral infection from coronaviruses like COVID-19, but also to deal with fibrosis in the lungs.
Anteris Technologies Ltd. raised AU$35 million (US$24.21 million) to fund clinical development of its 3D single-piece prosthetic heart valve implant, the Duravr, for the treatment of aortic stenosis.
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
In a blow to Aussie regenerative medicine company Regeneus Ltd., Japan’s Kyocera Corp. has pulled out of a licensing deal for Regeneus’ lead mesenchymal stem cell (MSC) therapy, Progenza, for osteoarthritis of the knee for the Japan market.
