Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
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.
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