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.
List view / Grid view
Regs & Legs
Market research suggests the new drug patent reforms in China, in addition to other regulatory changes, will incentivise innovative pharma research.
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.
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.
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
Stem cell therapy authorities urge the WHO to create an advisory committee for regenerative medicine and work to combat the rising use of unproven stem cell therapies worldwide.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.