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What strains should be in this year’s seasonal influenza vaccines?
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
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Drug Manufacturing
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African Union to receive 220 million doses of Janssen COVID-19 Vaccine
The African Vaccine Acquisition Trust (AVAT) has entered into an advanced purchase agreement for 220 million doses of Janssen COVID-19 Vaccine.
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GSK to provide fill and finish capacity for Novavax’ COVID-19 vaccine
Under a new agreement, GlaxoSmithKline will provide the fill and finish manufacturing capacity for 60 million doses of Novavax’ COVID-19 vaccine for use in the UK.
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EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
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Could viral vector shortages disrupt the COVID-19 vaccine roll-out?
According to GlobalData, AstraZeneca’s and Janssen’s COVID-19 vaccines could be impacted by global viral vector shortages.
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What is on the horizon for the pharmaceutical packaging equipment market?
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
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Merck to manufacture Janssen’s COVID-19 vaccine
Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
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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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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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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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Chemspec Europe 2021 postponed
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
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Regulatory challenges and myths in pharmaceutical 3D printing
Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.
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EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
