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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.
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,…
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.
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.
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…
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…
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…
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.
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
Pharma companies outsourcing clinical research support without focusing on safety are paying the price. Here, Natalia Vlcek, Pharmacovigilance Manager and EU QPPV at Arriello Group, offers some practical tips for ensuring best practice when it comes to safety in clinical research outsourcing.
In an ageing society where people are living longer, often with debilitating conditions that require complex medical interventions, how might the way we experience and consume our drugs be changed? In this article, Echo’s Nick Dormon discusses some of the key challenges currently facing pharmaceutical packaging design, including accessibility and…
In this article, EPR summarises the list of 10 recommendations for the UK Government, published by experts in the medicinal cannabis industry, to ensure the UK capitalises on the opportunities afforded by the market.
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
Here, Dr Matthew McMurray and Dr J Andrew Jones of Miami University explain why psychedelic drugs are attracting R&D as potential treatments for neuropsychiatric and degenerative disorders and how their discovery of an in vivo production technique could enable further advancement.
