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Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
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Regulation & Legislation
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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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Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
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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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UPC opt-out – a strategic balancing act for pharma
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail some…
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Challenges in pharmaceutical microbiology: looking to the future
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
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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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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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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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FDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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Forxiga approved in EU for chronic heart failure
Forxiga (dapagliflozin) has been approved in the EU for chronic heart failure across the full spectrum of left ventricular ejection fraction.
