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June 28, 2021

Coronavirus company news summary – Ampio Pharmaceuticals’ Phase II trial of Covid-19 drug underway – EMA approves new J&J Covid-19 vaccine production plant

By Darcy Jimenez

Biopharmaceutical company Ampio Pharmaceuticals has announced that patient randomisation and dosing of inhaled Ampion is underway in its multi-centre AP-019 Phase II clinical trial to treat respiratory distress due to Covid-19. President and CEO of Ampio Michael Macaluso claimed that the Phase I trial showed positive results in reducing all-cause mortality in Covid-19 respiratory distress by almost 78%. If the Phase II demonstrates similar results, the company will apply for emergency use authorisation for Ampion as a treatment for Covid-19 patients.

The European Medicines Agency has approved the production of Johnson & Johnson’s single-dose Covid-19 vaccine at a new site in Italy, as it aims to accelerate the supply of the vaccine in the European Union (EU). The approval comes after the EU stated that J&J was about to miss its EU supply target for the second quarter of 2021, as millions of doses were banned in Europe due to a contamination incident at a US site. The new Italian site, located in Anagni, will be operated by US-based Catalent, and will undertake vial filling and packaging of the J&J Covid-19 vaccine.

The Islamic Revolution Guard Corps (IRGC) of Iran has initiated a Phase I clinical trial of its domestically produced Noora Covid-19 vaccine. The vaccine is produced by  the Baqiyatallah University of Medical Sciences, and was launched by the IRGC Commander-in-Chief Major General Hossein Salami and Health Minister Saeed Namaki. The recombinant vaccine entered human trials after 16 months of research, and the first dose was administered to the chief of Baqiyatallah Hospital Hossein Samadinia. According to researchers, one million doses of the Noora vaccine could be produced every month, and this could be increased to up to three million doses per month.

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