Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Astellas, Astrazeneca, Biogen, Curevac Swiss, Cytodyn, Eli Lilly, Glaxosmithkline, Janssen, Kintor, Lintonpharm, Mayne, Mithra, Moleac, RDIF, Seagen, Shenzhen Chipscreen, Vir.
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting, including: Adagene, Antengene, Ascentage, Beigene, Eli Lilly, Innovent Biologics, Pharmabcine.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Central Drugs Standard Control Organization, World Health Organization.
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial.
With shortages of the COVID-19 drug, remdesivir, being reported in several states in India, the country’s Central Drugs Standard Control Organization is calling on state regulators to “immediately initiate remedial action to ensure supply of remdesivir injection to public and private hospitals.”
PERTH, Australia – The Australian government is recommending that Australians under 50 take the Pfizer Inc. COVID-19 vaccine due to the risk of rare blood clots associated with Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S). The move jeopardizes Australia’s vaccine rollout as it had planned for the majority of Australians to receive the Astrazeneca vaccine, which is being locally manufactured by CSL Ltd.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
The newly renamed Hutchmed (China) Ltd., previously known as Hutchison China Meditech Ltd. (Chi-Med), plans to sell $100 million of its American depository shares at $30.50 per ADS in a private placement to funds affiliated with Baring Private Equity Asia.
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