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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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Clinical Development
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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.
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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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Accelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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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.
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EMA releases human medicines highlights 2022 report
Medicines which represented significant progress in their therapeutic areas have been listed in the European Medicines Agency's Human Medicines Highlights 2022 report.
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Enzyme replacement therapy for alpha-mannosidosis gets FDA approval
The first and only enzyme replacement therapy approved for alpha-mannosidosis in the US has been cleared for adult and paediatric patients.
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Fusion to acquire radiologand therapy for prostate cancer
An investigational new drug application for an ongoing Phase II trial of an alpha-emitting radiopharmaceutical will be acquired by Fusion Pharmaceuticals.
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Neoadjuvant nivolumab improves long-term survival for lung cancer
Analysis of a Phase II trial for non-small cell lung cancer has suggested neoadjuvant nivolumab improved five-year recurrence-free survival compared with historical outcomes.
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Key developments: mRNA vaccines and therapeutics
EPR summarises results from key mRNA vaccine trials, highlighting the future potential of these innovative therapeutics.
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CAR T-cell therapy offers substantial remission rates in trial
In a Phase III study, a CAR T-cell therapy more than tripled progression-free survival compared with standard care for triple-class exposed multiple myeloma.
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Pfizer and BioNTech mRNA shingles vaccine study begins
A Phase I/II trial for the first mRNA-based shingles vaccine programme has been initiated by Pfizer Inc. and BioNTech SE.
