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FMF World Congress 2023: Janssen shares new data in HDFN
If approved, nipocalimab would be the first anti-FcRn therapy for EU pregnancies at high risk of haemolytic disease of the foetus and newborn.
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Biopharmaceuticals
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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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Lonza and Vertex to partner to manufacture diabetes cell therapies
The proposed collaboration between Lonza and Vertex Pharmaceuticals will support manufacture of stem cell-derived, fully differentiated insulin-producing islet diabetes cell therapies.
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European Pharmaceutical Review Issue 3 2023
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
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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New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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TAK-755 trumps plasma-based therapy, trial shows
Compared to plasma-based therapies, the only recombinant ADAMTS13 protein in development showed strong efficacy in a trial for congenital thrombotic thrombocytopenic purpura (cTTP), Takeda revealed.
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Webinar: How crucial is culture media selection in environmental monitoring? A roundtable discussion
A roundtable panel discusses culture media regulatory requirements and how media specifications could impact your environmental monitoring program in aseptic manufacturing.
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Reducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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Gene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
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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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New approach for small molecule nanosimilar analysis reported
A study on the small molecule antibiotic rifabutin has highlighted benefits of mechanistic compartmental analysis in evaluating nanomedicines.
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AMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
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Video: The route to faster microbial QC with the Milliflex® Rapid System 2.0
Learn how your lab can benefit from a rapid microbial detection platform for faster sterility, bioburden, in-process and product release testing.
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First adult anti-inflammatory cardiovascular drug approved
An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.
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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.
