Beigene Ltd.’s tislelizumab met its primary endpoint of noninferior overall survival vs. sorafenib as a first-line treatment in hepatocellular carcinoma (HCC), marking the eighth positive phase III trial readout for the anti-PD-1 drug across multiple cancer types and lines of therapy. Read More
Neither the primary endpoint of overall response rate nor the key secondary endpoint of progression free survival achieved statistical significance in Isofol Medical AB’s phase III Agent study of arfolitixorin in combination with 5 fluorouracil, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC), licensee Solasia Pharma KK reported. Read More
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS). Read More
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women. Read More
Glubio Therapeutics Inc. has raised $22 million in a series A+ round to support the development of its targeted protein degradation drugs. With the investment, Glubio expects to file INDs for two molecular glue degraders for hematological malignancies in early 2023 in both China and the U.S. Read More
Canwell Biotech Ltd. raised more than ¥100 million (US$14.8 million) in a series A+ financing. The funds will help accelerate trials for its pipeline of anticancer assets, such as the TLR7 agonist CAN-1012, and preclinical development of other projects too, CEO Henry Yu told BioWorld. The State Development and Investment Corporation Venture Capital Co. Ltd. was the round’s sole investor. Read More
Despite new laws and enforcement efforts, protecting intellectual property (IP) rights in China remains a big challenge for companies based in the U.S. and other countries. A case in point is China’s new patent law that came into effect in June 2021. Read More
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld. Read More
Paradigm Biopharmaceuticals Ltd. announced a AU$66 million (US$46.39 million) capital raise to fund its phase III pivotal trial for injectable Zilosul (pentosan polysulfate) to treat osteoarthritis of the knee. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Bioduro-Sundia, Ceapro, GSK, Hemoshear, Intron, Merck, Starpharma, Takeda, Tetra, Vir, X-Chem, Zai Lab. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Cullgen, Daewoong, Daiichi Sankyo, Eucure, Everest Medicines, Immvira, Innocare, Moderna, Novavax, SK, Tracon. Read More
