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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
List view / Grid view
Regulation & Legislation
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Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it
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.
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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…
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On-demand webinar: Contamination control strategy essentials
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
webinar
Navigating the transition from IVDD to IVDR
9 June 2021 | By Tecan
This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.
news
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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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.
whitepaper
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.
