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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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Regs & Legs
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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.
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PharmaLab Congress 2024 – what’s new for the third year in Düsseldorf/Neuss
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
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Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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Driving economic growth in UK with commercial clinical trials
The research “clearly demonstrates the financial and societal benefits that industry clinical trials bring to the economy, the NHS and to R&D in the UK”, APBI Chief Executive says about the report.
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First-in-class combination therapy authorised for endometriosis
The three-in-one oral daily tablet provides an additional treatment option to help women in the UK manage their endometriosis-associated pain.
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European Commission licenses first treatment for acanthamoeba keratitis
Following its European approval, the small molecule treatment is set to become the standard of care for patients with the ultra-rare disease.
