news
CHMP recommends first pegylated enzyme for Fabry disease
A PEGylated enzyme replacement therapy for Fabry disease has received recommendation for a marketing authorisation from the European Medicines Agency (EMA)'s human medicines committee.
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Biopharmaceuticals
news
Bioavailability enhancement services market to exhibit 11 percent CAGR
Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.
whitepaper
Application note: Rapid identification of Polysorbates 20 and 80 through amber bottles
How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.
news
Vitiligo treatment gets positive CHMP opinion
If approved, the cream formulation of the JAK inhibitor ruxolitinib will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union.
article
Taking advantage of protein charge properties for challenging separations
In this article, Mareia Frost, Scientific Leader at Abzena, explores how understanding the characteristics of protein‑based drugs, and applying the right techniques, means even the most complex biologics can be effectively separated from potentially-harmful impurities.
news
Imfinzi plus Imjudo approved in EU for advanced cancers
Hepatocellular carcinoma and non-small cell lung cancer patients are set to benefit from the recent approval of Imfinzi plus Imjudo combinations in the EU.
whitepaper
Article: The importance of real-time nanoparticle size analysis
The NanoFlowSizer, unique inline nanoparticle size analyser, is able to monitor nanoparticle suspensions and enable real time monitoring of processes.
news
Ph. Eur. rabbit pyrogen test replacement texts ready for public consultation
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
news
Simplified HIV treatment options effective in major trial
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
article
Moving towards oral delivery of biologics
In this article, EPR’s Caroline Peachey speaks to Talat Imran, CEO of Rani Therapeutics, about progress towards oral delivery of biologics using robotic capsules.
news
Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
news
PDA releases contamination control strategy report
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
article
Optimising fermentation with process analytical technology
This interview with Dr Marie Izac, Vaccine Drug Substance Unit Head at Sanofi Pasteur, elaborates on the use of process analytical technology – and specifically mass spectrometry – for continuous respiratory gas analysis.
news
AstraZeneca BTK inhibitor tablet approved in EU for leukaemia
The tablet formulation for AstraZeneca’s BTK inhibitor has gained EU approval for co-administration with gastric acid-reducing agents in chronic lymphocytic leukaemia patients.
news
FDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
