All articles by Catherine Eckford – Page 5
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NewsNovel bioprocessing technology demonstrates one-step continuous operation
Simultaneous concentration and buffer exchange of mAbs through asymmetric dialysis may advance end-to-end continuous bioprocessing, suggests AstraZeneca study.
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NewsKrystal Biotech wins MHRA approval for genetic medicine Vyjuvek
Authorisation expands treatment options for UK patients with the rare genetic skin condition dystrophic epidermolysis bullosa.
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NewsEU Commission agree to move Critical Medicines Act towards approval
Milestone agreement furthers proposals that help prevent drug shortages in Europe.
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NewsMakary resigns as commissioner of US FDA
The resignation adds to staffing pressure as the US medicines regulator navigates continuing challenges.
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NewsAI to accelerate Novo Nordisk’s Parkinson’s cell therapy
Cellular Intelligence’s AI-native platform to compress traditional process development for the pluripotent stem cell-derived dopaminergic progenitor therapy.
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NewsMHRA proposes modernisation of gene therapy products classification
UK medicines agency calls for a more technologically neutral approach to the current legal definitions of gene therapy medicinal products.
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NewsFDA refines strategy with one-day inspectional assessment pilot
Initiative shown to enhance agency’s efficacy by increasing the number of facilities it can assess, without comprising regulatory rigour.
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NewsNew OCABR vaccine guidelines to improve regulation efficiency
One new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases.
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NewsAmgen invests additional $300m to strengthen biomanufacturing in Puerto Rico
Expansion brings firm’s total US manufacturing commitment over the last year to nearly $2 billion.
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NewsNovartis to site seventh new facility in North Carolina
New active pharmaceutical ingredient (API) facility in Morrisville to enable end‑to‑end manufacturing in the US.
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NewsFDA marks progress in implementing real-time clinical trials
Advances agency’s goal in facilitating continuous trials, aimed at accelerating promising therapies.
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NewsBioplastic produced from hemp waste potential eco-alternative for packaging films
Plant-based biocomposites improved resource efficiency and added value from biomass waste, study shows.
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NewsBoehringer’s GLP-1 dual agonist survodutide shines in phase III trial
Survodutide could become first global glucagon/GLP-1 dual agonist, new phase III findings suggest.
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NewsLilly adds potential first-in-class Type II JAK2 inhibitor to haematology portfolio
The pharmaceutical company’s $2.3 billion acquisition of Ajax Therapeutics set to advance outcomes for myeloproliferative neoplasms.
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NewsOtarmeni Regeneron’s first genetic medicine to gain approval
Authorisation of the AAV gene therapy in the US marks a milestone for treating genetic hearing loss.
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NewsNovel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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NewsAmgen’s Chief Technology Officer Dr David Reese to retire
His two-decade tenure at the biopharmaceutical company has strengthened its aim for “convergent innovation” in medicine development.
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NewsAbbVie expands US footprint with new $1.4 billion manufacturing campus
Small volume parenteral (SVP) manufacturing investment represents company’s largest capital investment to date.
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NewsManufacturing data innovation set to accelerate medicine development
CMAC’s milestone aids the pharmaceutical industry’s transition from manual and siloed data operations to connected, intelligent manufacturing systems.
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NewsDigital framework could optimise pharmaceutical wastewater treatment design
Combining machine learning and modelling has shown promise for supporting efficient tetracycline degradation and minimising electrical energy consumption in wastewater treatment.