All articles by Catherine Eckford – Page 46
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NewsFirst CRISPR-based gene-editing therapy authorised
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.
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ArticleAdvancing clinical development in haematology oncology
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
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NewsChromatography technique developed as continuous on-line PAT tool
The widely used continuous chromatography technique, simulated moving bed (SMB) chromatography, developed to the micro-scale as a process analytical technology (PAT) application, has been shown to greatly increase mass spectrometry sensitivity.
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NewsCHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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NewsSandoz mobilises critical medicine production in Europe
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
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NewsNew acquisition to support global gene therapy manufacturing
Acquisition of Forge Biologics by Ajinomoto Co., Inc. is set to extend global capabilities in AAV and plasmid gene therapy manufacturing for Ajinomoto, Co. Inc.
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NewsUnified vision essential in UK advanced manufacturing
A new report outlines five critical actions for five of the UK’s leading manufacturing sectors to ensure sustainable innovation growth is achieved.
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NewsUSP General Chapter <660>—Glass revised
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
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NewsCould GSK myelofibrosis treatment gain EU-first approval?
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
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NewsNovel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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NewsFirst chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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NewsNovo Nordisk plans multi-billion Denmark manufacturing expansion
A major manufacturing facility expansion in Denmark will aim to “reduce water consumption with approximately 40 percent and energy consumption with approximately 50 percent compared to similar API processes in other facilities”, according to Novo Nordisk.
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NewsNew method could replace microbiology CFU assay
A new, more efficient colony counting method called the Geometric Viability Assay (GVA) could enable microbiologists to test potential new drugs such as antibiotics more quickly.
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NewsTargeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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ArticleDeveloping a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
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NewsSandoz and Teva achieve first-of-a-kind manufacturing certification
In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.
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NewsInnovative insomnia study aims to overcome major clinical trial bottleneck
A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.
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NewsRapid HPLC method could improve formulation QC studies
Researchers state the novel high-performance liquid chromatography with diode-array detection (HPLC-DAD) method can be utilised in routine quality control analysis of levofloxacin in pharmaceutical formulation and bioequivalence studies.
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NewsGilead reveals positive data for potential first-line adenocarcinoma treatment
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
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NewsMHRA authorises new treatment for rare lung cancer
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.