news
FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
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Regulation & Legislation
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
whitepaper
Application note: Impurity analysis of gabapentin by HPLC-UV-CAD
This application aims to replace the two separate compendial methods for the impurity analysis of gabapentin with one single HPLC method.
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On-demand webinar: Water systems – microbial monitoring
This webinar considers the fundamental importance of water system control within pharma processing and the best control and monitoring practices.
whitepaper
Whitepaper: Impact of a pandemic outbreak on vaccine development approach
This whitepaper explores vaccine development during a pandemic, a response to complex challenges that traditional manufacturing methods will not solve.
news
NICE recommend dapagliflozin for treating chronic kidney disease
The new draft guidance has recommended dapagliflozin as an option for treating certain people with chronic kidney disease (CKD) in adults.
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
whitepaper
Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
whitepaper
Toolkit: Nitrosamine analysis workflows
Everything you need to have confidence and compliance in your nitrosamine impurity analysis.
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Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
news
FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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Designing an ATMP manufacturing facility: from concept to completion
Remy Martin, business development specialist at cell and gene therapy manufacturing consultant, eXmoor Pharma, discusses 10 key considerations when creating a manufacturing facility, to ensure it meets requirements for both immediate needs and future growth.
news
CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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Towards a solution for the access challenges faced by combination treatments
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
