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The European Medicines Agency (EMA), which eased certain labeling requirements for COVID-19 vaccines in December, now says some of the same product labeling flexibilities may apply to COVID-19 therapeutics. Read More
New Jersey-based drugmaker Catalent has announced that it will significantly scale up manufacturing of the Johnson & Johnson (J&J) COVID-19 vaccine at its 300,000 square-foot facility in Anagni, Italy, which should help accelerate much-needed vaccine distribution in Europe. Read More
A letter to vaccination sites in the UK has cautioned that supplies of COVID-19 vaccines will be tight for about four weeks starting near the end of the month, but Pfizer has offered assurance that it is on track to meet its supply commitments on time. Read More
In another blow to AstraZeneca’s (AZ) COVID-19 vaccine, a peer-reviewed study has found that it failed to protect against mild-to-moderate infections caused by the virus’ South African variant. Read More
There are so many COVID-19 tests on the market that one of the conditions for granting an Emergency Use Authorization — that there are no such products available — no longer applies. Read More
Medicago and GlaxoSmithKline (GSK) have launched a global phase 3 trial evaluating Medicago’s plant-derived COVID-19 vaccine candidate when combined with GSK’s pandemic adjuvant. Read More
The U.S. government has ordered 500,000 more doses of AstraZeneca’s experimental long-acting antibody combination for preventing and treating COVID-19. Read More
In a revision of its Emergency Use Authorizations (EUAs) for Eli Lilly’s and Regeneron’s antibody combination therapies for COVID-19, the FDA is requiring the companies to assess the therapies against the mutant strains of the SARS-CoV-2 virus. Read More
Moderna is working to widen the utility of its COVID-19 vaccine and, over the past week, announced that it has begun to study its vaccine in kids aged six months to 11 years old, that it is testing a version of its vaccine that can be stored at warmer temperatures and that it launched a study of a modified COVID-19 vaccine to target the variant strain first identified in South Africa. Read More
The European Commission has announced that it expects to receive approximately 200 million doses of Pfizer/BioNTech’s two-dose COVID-19 vaccine in the second quarter, giving hope that the EU may reach its inoculation goals on time despite serious setbacks to vaccine deliveries. Read More
The test runs on the common cobas 6800/8800 Systems and features a pre-optimized assay design, ready-to-use cassettes and pre-defined software parameters. Read More
Aeterna Zentaris has entered a global licensing agreement for an oral COVID-19 vaccine candidate created at Würzburg, Germany’s Julius-Maximilians-University Würzburg. Read More