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Enabling multi-dimensional biotherapeutic analysis
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
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Biologics
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Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
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GM herpes virus fights advanced cancers
A Phase I trial showed early potential in using a genetically engineered herpes virus to combat advanced cancers that exhibited no response to immunotherapies.
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On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
webinar
Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
news
First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
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EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
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First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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Is localisation the answer for pharmaceutical supply chain resilience?
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
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AbbVie’s Skyrizi® shows long-term efficacy in psoriatic arthritis
Similar rates of skin improvement at week 100 indicate Skyrizi® (risankizumab) has consistent long-term efficacy in psoriatic arthritis patients.
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Takeda to invest €300 million in plasma-derived therapy production
Investing in a new production facility and carbon net-zero emissions warehouse in Lessines, Belgium, Takeda aims to expand access for rare and complex chronic disease treatments.
news
Checkpoint inhibitor combination shows promise in Merkel cell carcinoma
Dual checkpoint inhibitor blockade could be a promising first-line and salvage therapeutic option for advanced Merkel cell carcinoma, say researchers.
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US begins monkeypox vaccine and therapeutic trials
US National Institutes of Health initiates trials to evaluate antiviral tecovirimat (TPOXX) and possibility of delivering Jynneos vaccine intradermally.
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UV-based PAT could enable continuous protein purification
A multi-wavelength UV-based process analytical technology (PAT) could significantly reduce downstream protein purification timelines.
