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Two COVID-19 vaccine candidates being developed by Chinese pharma companies have already received emergency authorization in China, the country’s National Medical Products Administration (NMPA) revealed. Read More
Johnson & Johnson (J&J) says it will begin a phase 2 trial of its COVID-19 vaccine candidate in Spain, Germany and the Netherlands this week. Read More
Moderna said Friday that it is in talks with Japan’s Ministry of Health, Labor and Welfare to supply the country with at least 40 million doses of its COVID-19 vaccine. Read More
The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review. Read More
The FDA announced late Friday that it has decided to expand its Emergency Use Authorization (EUA) for Gilead Sciences’ remdesivir, allowing its use in patients with mild or moderate COVID-19 infections. Read More
HHS denied Friday that its termination of a prominent public relations consultant had anything to do with the recent controversy over the FDA Commissioner’s presentation on convalescent plasma as a COVID-19 treatment, while the FDA refused to shed any light on the reported firing of its head spokesperson. Read More
President Trump vowed during his acceptance speech at the Republican National Convention that a coronavirus vaccine will be ready by the end of the year even as many experts continue to express skepticism about such an expedited timeline. Read More
The FDA has detailed how the agency’s Office of Generic Drugs (OGD) will handle requests for drug application ownership transfers in a new manual of policies and procedures (MAPP). Read More