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Find Clinical Drug Pipeline Developments & Deals by Fujifilm holding
As part of the agreement, FFTC will receive direct access to PRESECO data in support of local regulatory submissions in Japan. PRESECO is investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19.
FUJIFILM Cellular Dynamics grants Sana a non-exclusive license under intellectual property rights owned or controlled by FUJIFILM Cellular Dynamics, and will provide iPSC cell lines (including research-grade and/or Good Manufacturing Practices (GMP)-grade iPSC lines) to Sana.
Japan has approved Avigan, known generically as favipiravir, as an emergency flu medicine. But concerns remain, as the drug has been shown to cause birth defects in animal studies and its effectiveness against COVID-19 has proven difficult to demonstrate.
The meta-analysis of nine clinical trials showed the drug, known generically as favipiravir, helped patients early on in their hospitalisation but failed to demonstrate statistically significant results in reducing mortality among those with mild to moderate COVID-19.
The Japanese Health Ministry said on Monday its medical review board concluded that clinical trial data to determine the efficacy of Fujifilm Holdings Corp’s COVID-19 drug candidate Avigan is inconclusive.
FUJIFILM Toyama Chemical has partnered with Carelink towards the deployment of Avigan in China, and signed a memorandum to grant Carelink the exclusive right to submit an application for imported drug approval.
FUJIFILM conducted a phase III trial in Japan for COVID-19 patients with non-severe pneumonia. Based on the results, it seeks to add, indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan.
Fujifilm will utilize its manufacturing facilities and infrastructure for lipid nanoparticle to handle operations relating to VLP Therapeutics' COVID-19 vaccine formulations, from process development to manufacturing for clinical trials.
The efficacy primary endpoint is time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, and to alleviation of symptoms (body temperature, oxygen saturation and chest images).
Although patients given the drug early in the trial showed more improvement than those who got delayed doses, the results did not reach statistical significance.