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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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Biologics
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FDA approves Libtayo® monotherapy for non-small cell lung cancer patients
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
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Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
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EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
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Video: Single versus multilayer film in cold chain bioprocessing
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
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Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
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BCG vaccine protects newborns against a variety of infectious diseases, finds study
According to researchers, ensuring that newborns in areas with high rates of infectious disease receive the BCG vaccine at birth, could have a major impact on infections and deaths.
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New regulatory landscape for biosimilars in the UK and EU post Brexit transition period
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
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Biosimilar uptake: a clinician’s perspective
To ensure that clinicians buy into biosimilars, it is important that they understand how products are analysed and compared to the originator molecules. Dr Fraser Cummings and Jonathan Sweeting discussed this issue at a recent virtual roundtable event, where they highlighted the complexities of biosimilar development pathways and approval processes. Here, Nikki Withers shares the…
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Application note: In-process monitoring of headspace oxygen levels
Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.
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EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
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250mn Europeans to be vaccinated with COMIRNATY® by the end of 2021
Pfizer and BioNTech have agreed to supply the European Union with 200 million additional doses of COMIRNATY in 2021, making the total 500 million doses.
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The importance of disaccharide excipients in biologics
Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
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Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, discover how biological and technological advances could enhance the clinical capabilities of CAR T-cell therapies and explore why clinicians need to be better educated about the development and licencing of biosimilars.
