PERTH, Australia – In a boost for Australia’s medical technology innovators, A$3.2 million (US$2.4 million) in partnership projects are being deployed to help get innovative new medical devices to the next steps of starting human trials and early-stage manufacturing.
PERTH, Australia – Ferronova Ltd. has developed an injectable magnetic and fluorescent tracer that can map the spread of cancer in the lymph nodes more accurately for improving the staging of complex cancers. The polymer-coated iron oxide nanoparticles show more detailed assessment of sentinel lymph nodes and detect micro-metastasis and isolated tumor cells that would otherwise not be detected.
HONG KONG – Chugai Pharmaceutical Co. Ltd. has obtained Ministry of Health, Labor and Welfare (MHLW) approval for a combination regimen containing antimicrotubule binding anti-CD79b monoclonal antibody Polivy (polatuzumab vedotin), bendamustine and Mabthera (rituximab) to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Qihan Biotechology Co. Ltd., a company known for its multiplexable genome editing technology, has yet again extended its series A financing, this time with a $67 million round that will support advancement of its allogeneic cell therapy candidates to IND in China. To date the company has raised more than $100 million.
HONG KONG – Johnson & Johnson Vision (J&J Vision) has received its first global approval from Japan for its Acuvue Theravision with Ketotifen contact lenses. The Japanese Ministry of Health, Labour and Welfare’s green light will help with patients with vision correction, while simultaneously alleviating ocular allergic symptoms for allergic conjunctivitis, while they wear the lenses.
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
HONG KONG – Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.