Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adlon, Alzamend Neuro, Hutchmed, Ildong, Immunic, Jazz, Lupin, Mesoblast, Puma, Prometic, Scpharmaceuticals.
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI.
Just months after Jazz Pharmaceuticals plc's inventory of a therapy key to treating certain acute lymphoblastic leukemia and lymphoblastic lymphoma patients appears to have run out, FDA approval has arrived for an alternative: a recombinant version of the medicine the company developed, Rylaze (asparaginase Erwinia chrysanthemi (recombinant)).
As life begins to return to a semblance of normal in many parts of the world, COVAX cautioned countries July 1 against adopting policies that favor specific COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Direct, Emergex, Lexeo, Solasia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Amoy Diagnostics, Cibiltech, Interventional Systems, Neuroelectrics, Riken Genesis, Viz.ai.
The World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 initiatives in 2021 through 2023 aimed at addressing persistent challenges impeding global progress against the three diseases and protecting hard-won gains from new pandemics like COVID-19.
Even as World Trade Organization (WTO) members continue to negotiate a proposal to waive intellectual property rights for COVID-19-related medical products, the organization agreed June 29 to grant a third extension to the transition period that exempts least developed countries from some of the IP provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.