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UK partnership set to revolutionise oligonucleotide manufacture
CPI, AstraZeneca, Novartis, and The University of Manchester will collaborate to facilitate large-scale manufacture of oligonucleotides.
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Therapeutics
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New workflow for the analysis of mRNA therapeutics
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
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Cell therapy first for chronic heart failure
In a Phase III trial, a new cell therapy has shown potential for the first time to treat inflammation, a major contributor to heart failure.
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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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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.
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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.
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Collaboration to support quality production of biologics
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
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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.
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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.
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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.
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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.
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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.
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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).
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EC approves first gene therapy for haemophilia B
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
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Medicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
