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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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Regulation & Legislation
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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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UK grants marketing authorisation to “landmark” breast cancer therapy
Seagen's Tukysa® (tucatinib) was approved in the UK as part of a combination regimen for the treatment of adults with locally advanced or metastatic HER2-positive breast cancer.
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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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Boom times for pharma M&A
Global mergers and acquisitions (M&A) activity last year was expected to decline from 2019 levels, mainly due to the COVID-19 pandemic and resulting uncertainty around the global economy, trade tensions between the US and China, and the presidential election in the US. However, James Baillieu from Bird & Bird reveals…
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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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Brochure: Fast and simple plasma protein binding studies
Supel™ BioSPME 96-Pin Devices vastly outperform current sample preparation techniques for plasma protein binding studies and free fraction analyses.
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Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
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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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AstraZeneca’s COVID-19 vaccines listed for emergency use by WHO
The Emergency Use Listing will allow doses of the COVID-19 vaccines to be distributed through COVAX, the WHO’s vaccine allocation facility.
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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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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.
