All Pharmacovigilance and safety oversight articles – Page 30
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NewsFirst 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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ArticleHandling 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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NewsNatural 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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NewsOral 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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ArticleLearning 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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NewsNew 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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NewsEMA’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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NewsImmunotherapy 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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NewsCHMP 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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NewsVitiligo 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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NewsCollaboration 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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NewsImfinzi 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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NewsPh. 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.
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ArticleChallenges 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.
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NewsSimplified HIV treatment options effective in major trial
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
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ArticleAccelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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ArticleUsing alkali-metal cation recognition of α-cyclodextrin to detect lithium ions by MALDI-TOF
Here, Ahmad Amini and Johan Carlsson from the Swedish Medical Products Agency discuss the use of matrix‑assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF MS) for identification of lithium in pharmaceutical preparations.
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NewsPDA releases contamination control strategy report
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
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NewsAstraZeneca BTK inhibitor tablet approved in EU for leukaemia
The tablet formulation for AstraZeneca’s BTK inhibitor has gained EU approval for co-administration with gastric acid-reducing agents in chronic lymphocytic leukaemia patients.
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ArticleAnalytical Techniques In-Depth Focus 2023
Articles explore analytical techniques for the analysis of mRNA therapeutics, computed tomography for characterisation of freeze-dried products and more...