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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.
The new implementation plan lays out the steps the UK Government and clinical research community will take to improve research and tackle health inequalities.
The European approval of Koselugo was based on its ability to reduce inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1.
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.
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
Market research suggests the new drug patent reforms in China, in addition to other regulatory changes, will incentivise innovative pharma research.
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE-300x278.png)
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE.png)
Professor Tom Clutton-Brock was awarded an MBE for his work in approving novel ventilators for the UK’s National Health Service during the COVID-19 pandemic.
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…
Health Canada has proposed a single regulatory framework for clinical trials for all health products that will support innovation and streamline drug and medical device development.
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
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…
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
