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Research shows that the antibodies induced by the Pfizer-BioNTech COVID-19 vaccine can neutralise SARS-CoV-2 viruses with the N501Y mutation.
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
According to an outlet, the in-house manufacturing of biopharma products has been threatened by the COVID-19 outbreak, especially in China.
Mylan and Upjohn (a Pfizer company) revealed they have delayed the transaction due to meeting restrictions and concerns over staff health and safety during the COVID-19 pandemic.
This In-Depth Focus highlights why bio-fluorescent particle detection is an effective method for enumerating present microbes and discusses ICH Q10 knowledge management; presenting five tips for improving your company’s knowledge management.
