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NICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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Biopharmaceuticals
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AAV gene therapy demonstrates positive activity in Duchenne muscular dystrophy
Initial trial results show the gene therapy enabled up to 85 percent of muscle fibres expressing microdystrophin in boys with Duchenne muscular dystrophy eight weeks post-injection.
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BMS inks CAR T cell therapy manufacturing deal with Cellares
Bristol Myers Squibb has signed a worldwide capacity reservation and supply agreement with Cellares for CAR T-cell therapy manufacturing.
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European Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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Webinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the…
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Monitoring pharmaceuticals in the environment
Andreas Häner, an environmental risk assessor at Roche in Group Safety, Security, Health & Environmental protection (SHE), speaks to EPR about how the pharmaceutical industry monitors manufacturing emissions that can impact local environments.
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Technology advancement driving growth of rapid sterility testing market
Rising demand for sterility tests and an expanding biotechnology industry is set to boost growth of the rapid sterility testing market between 2023 and 2032, a report states.
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Long-term data indicates “significant” potential of aGvHD microbiome treatment
In third line, MaaT013 represents the highest overall survival in acute graft-versus-host disease (aGvHD) when compared to reported literature evidence, according to MaaT Pharma.
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FUJIFILM plans $1.2 billion investment in major US manufacturing facility
Proposed additions to the cell culture manufacturing facility are set to make the site one of the largest cell culture biopharmaceutical CDMO facilities in North America.
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Seasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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ebook: Twin-screw extrusion for pharmaceutical applications
This compendium explains how hot-melt extrusion can help overcome common challenges in pharmaceutical development, with guidance on all stages of the HME process from formulation characterization to process design/development, and downstream processing.
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CRISPR technologies fuelling haematological innovations
Greater use of CRISPR-based therapies in clinical trials is expected to drive further advancements in precision medicine, GlobalData states.
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New partnership to advance European oligonucleotide manufacturing
Once built, the new manufacturing facility in Berlin is anticipated to help drive the production of high-quality oligonucleotide therapeutics.
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Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
