All Pharmacovigilance and safety oversight articles – Page 9
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NewsInnovating LNP design to improve mRNA therapeutics
The new approach involving refinement and optimisation of ionisable lipids could accelerate the development of mRNA therapies, research suggests.
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ArticleEasing the mental health burden with psychedelic therapies – what’s next for the regulatory and clinical landscape?
In this article, Steffanie Wilson, Vice President and Neuroscience Therapeutic Area Lead, Emmes Group, discusses the future of psychedelic research and highlights the impact of the FDA’s decision on Lykos Therapeutics’ NDA for its MDMA therapy to treat PTSD.
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ArticleThe future of media hydration: balanced media in automated single-use platforms
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
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ArticleEuropean Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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NewsGilead data lends insight into transforming HIV prevention landscape
Results suggest that the small molecule treatment could be an alternative to current medication that aims to prevent HIV infection and which require more frequent dosing.
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NewsFirst-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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NewsEncouraging data revealed for schizophrenia long-acting injectables
Key Phase III and real-world data highlight potential advancements in long-acting injectable treatment options for schizophrenia, Teva and Medincell share.
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NewsFinal Chapter <86> text published for early adoption
The Chapter for endotoxin testing using non-animal derived reagents will help quality professionals ensure the safety of sterile pharmaceutical products.
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NewsTrial highlights potential next-gen biologic for lung cancer
Preliminary results from an ongoing trial of a novel monoclonal antibody have confirmed favourable efficacy and safety in recurrent extensive-stage small cell lung cancer (SCLC).
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ArticleDeveloping 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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NewsEli 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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NewsDrug combination shows promise for mitigating microbial biofilms
Combining allicin with domiphen could reduce biofilm formation, providing a potential avenue for overcoming antimicrobial resistance, research suggests.
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ArticleInnovating 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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NewsDigitalisation 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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NewsHaemophilia 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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ArticleAdvancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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ArticleCPHI 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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NewsImproving packaging integrity of pharmaceutical borosilicate glass vials
The study offers promising data on strengthening borosilicate medical glass vials using ion-exchange, especially as there is limited research in this area.
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NewsFirst real-world study reveals encouraging efficacy for cell therapy
More than half of the multiple myeloma patients included in this study would have been ineligible for the Phase II CARTITUDE-1 clinical trial, research reports.
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ArticleFuture of oral small molecule drugs - addressing potential in multiple sclerosis
Advances in selectivity, safety, and patient convenience, oral small molecule drugs continue to be a key focus in drug development. Here, Dr Andreas Muehler and Daniel Vitt, PhD, the co-founders of Immunic Therapeutics, discuss the potential of Vidofludimus calcium as a breakthrough treatment for autoimmune diseases.