All articles by CE
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NewsExposure rate influences microbial viability risk during pharmaceutical freeze-thaw cycling
Research supports pharmaceutical microbiological risk assessments and thaw-handling steps during manufacture and storage.
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NewsAstraZeneca commits $2bn to advance ADC combination medicines for cancer
Investment and collaboration agreement with Summit Therapeutics to accelerate next-generation immuno-oncology regimens across multiple tumour types.
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NewsNovo secures €1.17bn long-acting injectable deal with Nanexa
Licensing agreement focuses on a delivery technology that provides sustained-release injectable peptides and offers potential to reduce treatment burden in obesity and type 2 diabetes.
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NewsEnhanced microbial cultivation method bridges transition between native habitats and the lab
Applying the continuous-flow technology enabled domestication of previously uncultured bacteria, addressing a key bottleneck in laboratory microbial cultivation.
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NewsBayer’s Kerendia approved in US as first new CKD and type 1 diabetes therapy in three decades
FDA’s latest approval authorises Bayer’s non-steroidal mineralocorticoid receptor antagonist (MRA) Kerendia for a third indication.
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NewsSanofi trims mature medicines portfolio and divests of three manufacturing sites
Divestment agreement expands decade-long collaboration between Sanofi and Cheplapharm, helps to hone Sanofi’s innovation focus.
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NewsNovo Nordisk tightens obesity market focus with ‘Novo’ name change
The Danish pharmaceutical giant hopes the strategic rebranding and modernising its culture will sharpen the company’s competitive edge in the rapidly evolving obesity and diabetes therapeutics landscape.
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NewsLonza expands large-scale spray-drying capacity in Oregon, US
New PSD-4 facility creates a global manufacturing hub for commercial spray-drying and addresses rising demand for bioavailability enhancement solutions across small molecules, biologics and mRNA modalities.
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NewsSimultaneous anaerobic bioreactor could accelerate sustainable biomanufacturing
Study suggests that enrichment of cellulose-degraders in the baffled compartments can aid stable co-digestion of high-strength wastewater and solid organic waste from biomanufacturing processes.
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NewsStrengthening female participation in clinical trials with AI-driven eConsent
In-depth: Study results highlight the growing momentum towards more real-time and technology-enabled clinical trials in the pharmaceutical industry and facilitates increased enrollment of female patients.
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NewsAtmospheric NOâ‚“ may contribute to NDSRI formation, study shows
Findings illustrate practical implications for risk assessment and control of nitrosamine formation in solid oral product manufacturing.
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NewsEFPIA and EAHP issue joint guidance on single unit barcode coding
Joint recommendations set out a phased roadmap for single unit barcoding of medicines across Europe, aimed at reducing medication errors at the point of care.
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NewsFDA opens consultation on regulation of botanical drug products
Agency’s call for feedback intended to support advancement of botanical drugs to expand beyond the four currently approved products in the US market.
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NewsPh. Eur. adopts new general chapter for phenolic antioxidant analysis
General chapter 2.5.46. introduces a single HPLC-UV method for simultaneous determination of seven plastic additives, streamlining compliance for pharmaceutical packaging materials.
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NewsInternational parallel regulatory review aids acceleration of innovative manufacturing for LAL/rFc
Milestone shifts how global pharmaceutical manufacturers approach post-approval life cycle management for medicines.
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NewsUse of Bunsen burners for laboratory asepsis context-dependent, study finds
Findings challenge routine use of the technique in laboratories to reduce airborne microbial contamination.
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NewsNew Phase III Tezspire data signals advance in epithelial-driven inflammatory disease treatment
First-in-class monoclonal antibody significantly improved both underlying inflammation and dysphagia in eosinophilic esophagitis, extending its potential beyond the airways to the oesophagus.
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NewsFDA approves first-in-class oral RAS inhibitor for pancreatic cancer
US authorisation illustrates how targeted therapies can reshape outcomes in cancer patients even in the most aggressive forms of the disease.
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NewsGenentech licenses Hanmi’s UCN2 obesity candidate in $2.3bn deal
Potential first-in-class treatment HM17321 offers a non-incretin mechanism of action and differentiated profile from existing GLP-1-based treatments for obesity.
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NewsEC approves Acadia’s trofinetide as first EU Rett syndrome treatment
European approval of the IGF-1-derived small molecule analogue offers a new option for patients aged five and over with the rare neurodevelopmental disorder.