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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…
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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.
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…
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
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.
BARDA has awarded more funding to Public Health Vaccines to support the development of a virally vectored vaccine against Marburg virus infections.
Researchers anticipate the growth of the aging population and rising investment in biologic drugs to promote the expansion of the global active pharmaceutical ingredient (API) market.
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
BioNTech is evaluating its investigational therapeutic mRNA-based cancer vaccine, BNT111, in combination with Libtayo® (cemiplimab) for the treatment of melanoma.
The trial will assess a monovalent mRNA-based vaccine candidate against seasonal influenza caused by the A/H3N2 strain.
A South African consortium will be the first to establish a COVID-19 mRNA vaccine technology transfer hub to scale up vaccine production and access.
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.
