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Reconfiguring COVID and influenza vaccines for long-term effectiveness

pharmaphorum

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. The technology. Antibodies cover the pathogen of the virus and neutralise it.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. 2004; 29: 100298. J Pharm Sci.

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Mesoblast pummelled as Novartis exits COVID deal

pharmaphorum

.” It said the emergence of the Omicron and other variants suggests that COVID-19 “is likely to remain a serious global problem and to provide a major commercial opportunity for Mesoblast, with a steady state of intensive care unit (ICU) ARDS patients irrespective of vaccines and anti-viral treatments.”

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Navigating delivery challenges of nucleic acid therapeutics

European Pharmaceutical Review

According to the authors, self-amplifying RNA (saRNA) could be a next-generation vaccine platform, but it requires smart drug delivery vehicles to maintain the long-term stability and efficiency of the drug. stated that between 2004 and 2021, 23 NA therapeutics were approved. Ingle et al.

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ICH Q6(R1): test criteria and specifications

European Pharmaceutical Review

EMA/CHMP/ICH/167068/2004. Internet] Vaccines Europe. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. 2021; 13(1): 48. ICH Q8(R2) Pharmaceutical Development – Scientific Guideline. 22 June 2017. ICH Q9(R1) Quality Risk Management – Scientific Guideline. 3 February 2023.

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Accommodating Multiple Modalities in the Same Facility

ISPE

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. EU human tissues and cells directive 2004/23/EC; 7. Viral antigen vaccines. Animal tissue.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

The development of an effective COVID-19 vaccine has been universally recognised as our way out of the pandemic, and humanity has seen the tangible impact of vaccines saving countless lives on a massive, global scale. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. appeared first on.