Alterity Therapeutics Ltd. has begun phase II trials with its lead candidate, ATH-434, in multiple system atrophy, a rare and highly debilitating Parkinsonian disorder.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
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.
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).
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.
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.
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
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