PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
PERTH, Australia – Sydney-based Immutep Ltd. announced that Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group International is aiming to get its most advanced candidate, HQP-1351, to market this year.
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway.
An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
New approaches to trials, digitalization and the effective use of technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and devices are developed.
Three months after completing what it said was the largest development and commercialization deal by a Chinese biotech, I-Mab Biopharma Co. Ltd. is moving the monoclonal antibody at the heart of the deal deeper into the clinic.