Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Agenus, Bristol Myers Squibb, Cytodyn, Diurnal, Hangzhou Chance, Iterum, Moderna, Recipharm, Zydus Cadila.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
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.
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.
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