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Takeda Pharmaceutical has reached a mutual agreement with German contract manufacturer IDT Biologika to produce doses of Johnson & Johnson’s COVID-19 vaccine. Read More
The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More
HHS announced that it will restrict distribution of Eli Lilly’s COVID-19 antibody therapy, bamlanivimab, in three states because of concerns about its effectiveness against a variant strain of the virus first identified in California. Read More
Moderna announced that it has dosed the first participants in its phase 1 trial of mRNA-1283, its “next generation” COVID-19 vaccine candidate that’s being developed to have more relaxed temperature requirements for easier distribution and administration. Read More
France, Italy and Germany have become the latest European countries to halt inoculations with AstraZeneca’s COVID-19 vaccine after 37 cases of blood clots were reported, joining an increasing number of other member states in temporarily putting them on pause as a safety review is conducted. Read More
The transaction is anticipated to finalize in the second quarter of the year, after which GenMark will continue to operate at its Carlsbad headquarters. Read More
Pelican said that the test has high sensitivity in both symptomatic and asymptomatic patients and is able to detect known new viral variants as well. Read More
Users running the test should keep an eye out for unexpected clusters of positive Flu B results, which may indicate a tube leak, and repeat tests when two or three analytes are positive, as different results on the repeat test could indicate abnormal PCR cycling. Read More
The European Medicines Agency (EMA) said severe allergies should be included in the list of potential side effects associated with the AstraZeneca/Oxford University vaccine. Read More
Brazil’s health regulator, ANVISA, has given full approval to the AstraZeneca/Oxford University COVID-19 vaccine, following its previous authorization for emergency use. Read More
India’s and South Africa’s proposal to temporarily waive intellectual property rights for COVID-19 vaccines and medicines was stopped once again by opposition from wealthy Western nations, including the U.S., during the World Trade Organization (WTO)’s meeting last week, in a victory for the pharma industry. Read More