whitepaper
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.
List view / Grid view
Regulation & Legislation
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.
article
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…
article
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.
article
Accelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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
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).
news
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.
article
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.
news
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.
news
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.
news
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).
news
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.
article
Five potential EU regulatory changes impacting the life sciences industry in 2023
Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions…
news
ABPI warns against revenue clawback rate rises
The Association of the British Pharmaceutical Industry (ABPI) has urged immediate government action is needed against the planned UK statutory revenue clawback rate rise for branded medicines.
