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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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Drug Markets
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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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Digitalisation propelling automated microbiology market growth to 2033
Increased adoption of artificial intelligence (AI) and machine learning (ML) in microbiology is set to be a key driver of the global automated microbiology market to 2033, research asserts.
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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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European manufacturing facility to strengthen gene therapy supply
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
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Sepsis: addressing unmet needs for a global priority
Limited funding and a lack of drugs targeting the root cause of sepsis are some of the current obstacles when addressing the disease burden, GlobalData says.
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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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Innovative pharma-government partnership to enhance UK clinical trials
The first-of-a-kind investment supports the UK government’s objectives to boost clinical trials, improve patient access to novel treatments and increase competitiveness in life sciences.
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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.
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Alzheimer’s drug milestone “bittersweet” for certain patients
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
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Harnessing the GLP-1R medicine wave
As a promising treatment for type 2 diabetes and obesity, based on key trial data, the market for glucagon-like peptide-1 receptor (GLP-1R) therapies looks set to generate major sales up to 2030.
