HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis. Read More
The Korea Export Import Bank (KEXIM) took a step toward fulfilling its mandate to finance Korean companies’ overseas expansion by seeking managers for a new ₩400 billion (US$328 million) fund. Read More
A new, worldwide coalition of plasma companies seeking to develop and deliver a hyperimmune immunoglobulin therapy for fighting COVID-19 takes the view that many hands make light work. Read More
HONG KONG – China and U.S.-based Zai Lab Ltd. has signed on to develop and commercialize REGN-1979, a CD20xCD3 bispecific antibody from Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Read More
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. reported interim data showing that lead candidate paxalisib (formerly GDC-0084) saw a positive overall survival signal in its phase II glioblastoma trial, and the company raised AU$7.2 million (US$4.4 million) days after the data were released. Read More
BEIJING – China, Yantai-based biologics maker Remegen Ltd. has raised about $100 million in a private round led by Lilly Asia Ventures and Lake Bleu Capital. Read More
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. Read More
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Read More
“Vaccines, obviously, are the ultimate solution for pandemics,” Rino Rappuoli told BioWorld. They have, he added, “already eliminated a lot of pandemic threats – smallpox, influenza, poliomyelitis.” Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Drug Enforcement Administration, Department of Health and Human Services, FDA, International Coalition of Medicines Regulatory Authorities, EMA, European Commission, National Institute for Health and Care Excellence, NIH, Office for Human Research Protections, Pharmaceuticals and Medical Devices Agency, Therapeutic Goods Administration. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Aslan, Bausch Health, Biocryst, Bridge, Eli Lilly, Firstwave, Fujifilm, Kazia, Laurent, Mesoblast, Neuclone, Viriom. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Algernon, Arcturus, Ascentage, Ascletis, Astellas, Athersys, Beigene, Bellerophon, Biohaven, Calcimedica, Can-Fite, Hope, Predictive, Ridgeback. Read More
