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ebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
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Biologics
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Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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Innovative PAT-based filtration strategy reported for continuous biomanufacturing
The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
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Innovation key for boosting UK biopharma competitiveness
Solutions for technology and government policy to address current challenges and drive economic growth in biopharma and Medtech have been recommended in new reports.
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BioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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First gene therapy approved for Haemophilia A
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
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First cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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UK trial to test psilocin-based drug for major depressive disorder
A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Alzheimer’s vaccine granted Fast Track designation
The US FDA has given Fast Track designation to an active immunotherapy vaccine that “specifically targets the most toxic forms of amyloid beta (Abeta)”.
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Microbiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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ebook: First-in-human solutions for small and large molecules
Partnering with a drug development solution company that anticipates and mitigates roadblocks can save you time and money. Discover how in this eBook.
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Video: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
