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.
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.
LONDON – Moves to expand the legal remit of the European Medicines Agency (EMA) and give it more powers to deal with the COVID-19 pandemic and future health emergencies are moving to fruition, after the European Parliament and national health ministers in the European Council separately voted through the proposal.
While the amount of regulatory data in 2021 is up by 19% over last year, the 90 approvals by the U.S. FDA through late June is a decline of 17% over the same period in 2020, although the agency gave its blessing to the highest number of new molecular entities within the last several years.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
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