EMA begins rolling review of BNT162b2 COVID-19 vaccine
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
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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 FDA has released new guidance for sponsors regarding Emergency Use Authorizations for potential COVID-19 vaccines.
Five labs have been selected by the Coalition for Epidemic Preparedness Innovations (CEPI) to act as a global network for the assessment of COVID-19 vaccine immunogenicity.
5 October 2020 | By Merck KGaA
This on-demand webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators.
A new opinion piece from Watson-Marlow Fluid Technology Group has been launched.
Watson-Marlow Fluid Technology Group discusses how the biopharma community is coming together to solve the global vaccine development challenge.
The EMA's human medicines committee has initiated a rolling review of AstraZeneca's COVID-19 vaccine candidate to test its efficacy.
The experimental COVID-19 vaccine, mRNA-1273, was well-tolerated and elicited a strong immune response in older adults during a Phase I trial.
US outsourcing organisation GRAM is set to undertake the aseptic fill and finish manufacture of J&J's COVID-19 vaccine candidate.
Researchers suggest, based on certain exclusions, older people are likely to be underrepresented in 50 percent of COVID-19 trials and all vaccine trials in the US.
The trial will evaluate the safety and efficacy of the Novavax’ NVX-CoV2373 vaccine candidate in approximately 10,000 UK participants.
A Phase III clinical trial to evaluate J&J's COVID-19 vaccine in multiple countries has enrolled its first patients.
A contract for 300 doses of the investigational COVID-19 vaccine candidate has been signed by the European Commission (EC).
As the COVID-19 pandemic and the search for an effective preventative vaccine continues, the Serum Institute of India has entered into manufacturing agreements with both Novavax and Codagenix to help supply their experimental COVID-19 vaccine candidates.
Prime Minister Boris Johnson visited the construction site of the VMIC and met scientists and engineers at the forefront of the UK’s COVID-19 response.