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European Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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Regs & Legs
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Whitepaper: What to expect from a regulatory inspection, an NSF expert guide
Regulatory inspections can be challenging, but proper preparation turns them into opportunities for improvement and compliance demonstration.
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First-of-a-kind EU approval granted for eosinophilic esophagitis medicine
With its novel approach for addressing a fundamental cause of eosinophilic esophagitis, approval of the biologic marks a potential new standard of care for paediatric patients.
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Life sciences response to 2024 Autumn Budget
Research and innovation is highlighted in the UK’s Autumn Budget as a priority ‘crucial national asset’ to aid long-term economic growth.
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Whitepaper: Optimise organisational culture & quality maturity
31 October 2024 | By NSF
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
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Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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World-first medicine manufacturing regulatory framework to be implemented
The new regulation could become lawful in the UK next year, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
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Innovating allergy drug delivery with a needle-free alternative
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
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Haemophilia treatment with new delivery method approved
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.
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EMA publishes EU strategy to 2028
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
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CPHI Milan 2024: everything you need to know
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.
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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
This feature partnership covers how pharma companies can ensure they are end-to-end compliant with Annex 1 for their primary packaging via a robust CCS.
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European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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First-in-class therapy approved for schizophrenia
The “landmark” approval represents the first new class of medicine in several decades for treating schizophrenia.
