news
EC approve Zeposia® to treat ulcerative colitis
The European Commission (EC) has granted Zeposia® (ozanimod) a marketing authorisation to treat people with ulcerative colitis.
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Regs & Legs
Whitepapers/App Notes/Posters
Case study: Amino acid analysis for EP compliance
An Ion Chromatography solution, devoted to fast turnaround of raw material testing for amino acids per the EP monographs.
Whitepapers/App Notes/Posters
Whitepaper: Drug repurposing strategies to shorten timelines
This whitepaper explores the drug repurposing, where known clinical candidates or commercially approved molecules are evaluated for new targets and indications.
news
NICE recommends risdiplam for spinal muscular atrophy
The new draft guidance recommends Evrysdi (risdiplam) to treat spinal muscular atrophy as part of a managed access agreement (MAA).
news
EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
news
FDA approves first drug to treat common form of dwarfism in children
The US Food and Drug Administration (FDA) approves vosoritide injection to improve growth in children at least five years of age with achondroplasia and open epiphyses.
Whitepapers/App Notes/Posters
User guide: Calibration and adjustment of dispensing systems
User guide for the calibration of pipettes and dispensers in the laboratory.
news
NICE approves first long-acting injectable HIV-1 treatment
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
news
European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
article
Social media is transforming our understanding of drug safety
Here, Daniel Ghinn of CREATION.co discusses the growing role social media analysis is playing in helping to provide pharmaceutical companies and health regulators with real-world evidence on drug safety.
news
NICE does not recommend elosulfase alfa for Morquio A syndrome
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
news
FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
news
EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
Whitepapers/App Notes/Posters
Application note: Impurity analysis of gabapentin by HPLC-UV-CAD
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
video
On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.