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Novel small molecule drug facilitates leukaemia remission
Leukaemia patients went into remission when given a novel drug containing a small molecule that inhibits menin and MLL1 interaction, a study showed.
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Drug Safety
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Injectable peptide rapidly reduces intracranial pressure
A study for idiopathic intercranial hypertension is the first to show rapid and a major reduction in brain pressure and monthly headaches.
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First nasal monoclonal antibody COVID-19 treatment shows potential
COVID-19 and multiple sclerosis patients experienced reduced inflammation when given the first nasal monoclonal antibody in a pilot trial.
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Handling HPAPIs safely – what does it take?
Here, Veranova's Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
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Natural allopregnanolone made orally bioavailable
Designed to treat anxiety and postpartum depression, a biotherapeutics company has made natural allopregnanolone orally bioavailable without permanent chemical modification.
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Oral PCSK9 inhibitor substantially reduces cholesterol, study finds
One of the first oral PCSK9 inhibitors tested in clinical trials significantly reduced low-density lipoprotein (LDL) cholesterol levels in patients with high cholesterol and/or heart disease.
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
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EMA’s human medicines committee (CHMP) meeting highlights – February 2023
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
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Immunotherapy before surgery benefits melanoma patients
In a Phase II trial, immunotherapy drug pembrolizumab significantly lowered the risk of recurrence for stage III-IV melanoma patients when given before and after surgery.
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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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Vitiligo treatment gets positive CHMP opinion
If approved, the cream formulation of the JAK inhibitor ruxolitinib will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union.
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Collaboration to support quality production of biologics
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
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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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Ph. Eur. rabbit pyrogen test replacement texts ready for public consultation
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
