The latest coronavirus updates and developments impacting the global pharmaceutical supply chain…
25 August:
• AstraZeneca dismisses reports it is in talks with the US government over a potential Emergency Use Authorisation for its COVID-19 vaccine, AZD1222. AstraZeneca “has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” the company says in a statement.
24 August:
• Moderna says it has concluded advanced exploratory talks with the European Commission to supply 80 million doses of its COIVD-19 vaccine candidate, mRNA-1273. The potential purchase agreement provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.
• Catalent Cell & Gene Therapy says it will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland. Catalent will prepare the facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance starting late in the third quarter of 2020. The agreement expands on Catalent’s previous agreement with AZ that its facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.
23 August:
• The US Food and Drug Administration issues an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. The agency says that “based on scientific evidence available, …this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.” The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration by health care providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19…
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