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At its latest meeting, EMA’s human medicines committee (CHMP) recommended the approval of four medicines, seven extensions of therapeutic indication and laid out recommendations for diabetes treatment outside of the EU.
Are environmental isolates truly beneficial in qualifying microbiological methods? Here EPR summarises Tim Sandle’s recent paper on the debate.
The results indicate that mRNA-1273.211 at the 50 µg dose level induced higher antibody responses than the 50 µg mRNA-1273 booster, even when additional variants of concern were not included in the booster vaccine.
The new chemical reaction, a carbon-hydrogen amination cross-coupling reaction, creates a faster, simpler way of making tertiary amines without the inherent limitations of classic methods.
IRBM’s goal will be to help ensure a more resilient global response to future epidemics by producing second generation vaccines and treatments for SARS-CoV-2 and new coronaviruses.
The facility is designed around a central unit that comprises several fully digitalised modules, which can produce up to four vaccines simultaneously, regardless of the vaccine technology used.
The scale up in annual capacity and expansion of Achilles' global clinical manufacturing footprint will see its second site in the UK and first site to be established in the US.
Phase III trial shows Evusheld (tixagevimab and cilgavimab) significantly reduces the risk of developing symptomatic COVID-19 in vulnerable populations.
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-300x278.jpg)
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-e1650536525880.jpg)
After first payment of $1bn to Biogen, Samsung Biologics has now fully acquired Samsung Bioepis.
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
The results of a recent international study suggest that left-handed gold nanoparticles can increase vaccine effectiveness by 25 percent, providing useful adjuvant capabilities.
WuXi Biologics awarded the Bioprocessing Excellence in Viral Clearance and Safety accolade for the second time at the Asia-Pacific Bioprocessing Excellence Awards (ABEA) 2022 event.
GlaxoSmithKline has announced the agreed $1.9bn acquisition of biopharmaceutical company Sierra Oncology, which specialises in treatments for rare forms of cancer.
Cambrex expands API manufacturing capacity at flagship US facility and Asymchem completes construction of two new Chinese API production sites.
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
