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EMA to assess whether COVID-19 Vaccine Moderna can be used in adolescents
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.
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Regulation & Legislation
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Experts call for improved oversight to combat rise of unproven stem cell therapies
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.
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Infographic: How different endotoxin testing platforms work
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
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Alzheimer’s drug Aduhelm™ authorised in US under accelerated approval
Aduhelm™ (aducanumab-avwa) is the first new treatment approved for Alzheimer’s since 2003 and the first therapy to target the fundamental pathophysiology of the disease – amyloid plaques.
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The current limitations facing biosimilar products and manufacturers
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
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EU regulators release medicine demand forecasting guidance for future crises
The new recommendations, developed in the context of the COVID-19 pandemic, are designed to help countries and other stakeholders forecast demand of medicines in future pandemics.
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100 Days Mission: “landmark collaboration” to protect people against future pandemics
Governments and life science leaders agree to work towards slashing the time to develop and deploy interventions and diagnostics for future pandemic threats to 100 days.
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COVID-19 Vaccine Moderna update
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
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WHO lists the Sinovac-CoronaVac COVID-19 vaccine emergency use
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
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EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
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UK approves Janssen COVID-19 Vaccine
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.
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FDA approves sotrovimab for emergency use in treating COVID-19
The FDA granted emergency use authorisation to the monoclonal antibody sotrovimab as a treatment for mild-to-moderate COVID-19 in certain adult and paediatric patients.
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Competition and Markets Authority investigating AstraZeneca’s Alexion acquisition
The UK’s competition authority will assess whether AstraZeneca’s acquisition of Alexion will result in a “substantial lessening of competition”.
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Ten recommendations to foster the UK’s medicinal cannabis market
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.
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Technical bulletin: Nitrosamines: Questioning the current analytical approach
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
