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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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Vaccines
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Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 2)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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Merck to manufacture Janssen’s COVID-19 vaccine
Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
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Application sheet: Mobile testing LabPODs
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
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Whitepaper: Transmissible disease defense unit
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
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Case study: Oxygen monitoring during shelf life
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
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FDA approves the Janssen COVID-19 Vaccine for emergency use
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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EMA issues its requirements for adapting COVID-19 vaccines for viral variants
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
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FDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
