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Articles
Trends in the vaccine contract manufacturing market
While we all know that COVID-19 has promoted growth in the vaccine contract manufacturing market, what other factors are impacting the field? In this article, EPR summarises the trends and opportunities identified by a new market research report.
Making use of those ‘in the know’
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
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…
Guide to Data Integrity
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
Solid- and Liquid-State NMR for monitoring of polysaccharide antigen in the manufacturing process
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
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.
Manufacturing, Packaging & Logistics In-Depth Focus 2021
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
European Pharmaceutical Review Issue 3 2021
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,…
France’s temporary authorisation (ATU) programme: reform implications
The new ATU programme may support more efficient use of healthcare spending but could it mean fewer patients receive early access to treatments? Here, experts from Charles River Associates discuss the new ATU programme reforms and how they could impact pharma.
COVID-19 antibody therapeutics – where are they now?
In this article, EPR’s Hannah Balfour explores the current usage of monoclonal antibody therapies for COVID-19, with commentary from Professor Adrian Streinu-Cercel of the Carol Davila University of Medicine and Pharmacy.
Realising the therapeutic potential of MDMA
Psychedelic drugs are gaining popularity in the pharmaceutical R&D sector because of their apparent benefits for people suffering with neuropsychiatric disorders - and those which are resistant to existing therapies in particular. In this article, Imperial College London’s Professor David Nutt discusses the evidence underlying the development of psychedelic therapies…
Navigating pharmacovigilance complexity in the US and EU: notes for biotechs
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
Becoming a Benefit Corporation and a certified B Corp: how sustainability practices may positively impact business operations
In this article, Giacomo Chiesi from Chiesi Group outlines why the company took steps to become Benefit Corporation and B Corp certified, how this status may impact business and the associated operations.
