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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
Smart use of off-patent medicines critical for post-COVID healthcare
2021 Medicines for Europe-IGBA conference speakers assert that off-patent medicines will be crucial to rebuild healthcare post-COVID-19.
Influenza vaccine with COVID-19 booster shot shows positive results
Sanofi’s Fluzone® with Moderna’s COVID-19 mRNA investigational booster dose showed an immunogenicity response similar to individual doses.
AZD7442 antibody combination reduces COVID-19 risk by 50 percent
AZD7442 is the first long acting antibody (LAAB) combination shown to prevent and treat severe COVID-19 infection in Phase III trial.
Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
Revolutionary biomass-based plastic used for blister packaging
Astellas' use of biomass-based plastics represents the world's first use of biomass plastic for drug blister packaging.
Alnylam joins the Medicines Manufacturing Innovation Centre
Alnylam joins the third Grand Challenge (GC3) consortium to help overcome barriers to the manufacture of oligonucleotides.
Mass spectrometry for gene therapy vector analysis
Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.
EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
Lumakras™ displays positive results in Phase Ib cancer study
Lumakras™ (sotorasib) demonstrated effective response rates against non-small cell lung cancer and colorectal cancer in Phase Ib trial.
Moderna’s mRNA facility in Africa to manufacture 500 million vaccine doses
Moderna will build an mRNA facility in Africa to manufacture 500 million doses of their COVID-19 vaccine and other products per year.
Opaganib reduces COVID-19 mortality by 62 percent in Phase II/III study
Opaganib is the first oral pill-based therapy to significantly reduce mortality outcomes in hospitalised COVID-19 patients.
WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
COVID-19 vaccines will require outsourced manufacturing, says report
The pharma industry will need to outsource manufacturing for COVID-19 vaccine doses for booster doses and children, reports GlobalData.
EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
