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WEVEE vaccine shows promise against trio of rare but deadly viruses
Phase I trial data suggests that a vaccine targeting three mosquito-borne encephalitis viruses is safe and can elicit an immune response.
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Drug Safety
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Production of Novartis’ radioligand therapy suspended
Novartis has suspended production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey as it addresses potential quality issues identified in its manufacturing processes.
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Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
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The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
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Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
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EMA’s human medicines committee (CHMP) April 2022 meeting highlights
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.
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Product hub: The new MAS-100 Atmos® microbial compressed gas sampler makes it simple to sample
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
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Ensuring consistency and stability in antibody therapies
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
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New data on bivalent COVID-19 booster platform from Moderna
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.
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Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
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Your endotoxin experts
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
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Evusheld reduces risk of symptomatic COVID-19 in high-risk population
Phase III trial shows Evusheld (tixagevimab and cilgavimab) significantly reduces the risk of developing symptomatic COVID-19 in vulnerable populations.
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WuXi Biologics awarded for excellence
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.
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Draft guidance to improve US clinical trial diversity
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.