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British pharma’s 2021 Code of Practice now in force
The ABPI’s 2021 pharmaceutical industry Code of Practice aims to increase transparency, encourage collaboration and improve patient care.
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Therapeutics
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How could waiving COVID-19-related intellectual property rights affect biopharma?
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
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Germany still second largest producer of EU-approved active biopharmaceutical substances, finds report
A new medical biotechnology report shows Germany’s biopharmaceutical industry is thriving with recombinant antibodies being a key focus area.
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Collaboration to develop neurostimulator for inflammatory disease treatment
neuroloop and Merck will combine their expertise to develop a neurostimulator that can safely and effectively treat chronic inflammatory diseases.
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Partnership to revolutionise RNA production
Under a strategic collaboration eTheRNA immunotherapies and Quantoom Biosciences will develop a novel, scalable RNA production system.
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Bioprocessing & Bioproduction In-Depth Focus 2021
Download this in-depth focus to discover why new licensing guidance could prompt a biosimilar boom in the UK and learn about recent developments in O-glycan analytical approaches for therapeutic proteins.
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How off-patent strategies benefit patient care
Graeme Duncan, CEO at ADVANZ PHARMA, discusses how targeted strategic investment within the off-patent sector can add value and enhance choice for patients and healthcare professionals alike, while helping to drive and maintain innovation within the pharmaceutical industry.
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New regulatory guidance could lead to UK biosimilar boom
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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O-glycan analysis of therapeutic proteins enabled by O-glycoprotease
Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
whitepaper
Application note: From our platforms to your pen injector
Nemera offers four product platforms for pen development and manufacturing. These include reusable and disposable devices which are designed for various therapies to meet key users’ needs.
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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FDA approves Actemra for emergency use in hospitalised COVID-19 patients
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
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VIRTUAL ROUNDTABLE HIGHLIGHTS: Emerging tools for the analysis of biologics and biosimilars
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
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Formulation, Development & Delivery In-Depth Focus 2021
Articles in this in-depth focus discuss the development and delivery challenges associated with mRNA vaccine technology and explore how investing in the off-patent drug sector can benefit both pharma innovation and patient care.
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Collaboration working to promote health research, development and innovation
A strategic European health research and innovation agenda is being compiled by five industry associations and the European Commission.
