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Paediatric and adolescent COVID-19 vaccines update
The EMA is evaluating whether to lower the age at which Comirnaty can be administered and Novavax has begun testing its COVID-19 vaccine in paediatric patients.
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Biologics
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Remestemcel-L reduces ARDS mortality in those under 65 years old
New data shows patients with COVID-19-related Acute Respiratory Distress Syndrome (ARDS) were up to 75 percent less likely to die when treated with remestemcel-L and dexamethasone.
![A cryomicroneedle patch ready for deployment [Credit: Chang et al. /DOI number: 10.1038/s41551-021-00720-1].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/cryomicroneedle-patch-300x278.jpg)
![A cryomicroneedle patch ready for deployment [Credit: Chang et al. /DOI number: 10.1038/s41551-021-00720-1].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/cryomicroneedle-patch-e1620132484839.jpg)
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Novel cryomicroneedle patch successfully delivers therapeutic cells in mice
Researchers have developed a new generation of microneedle technology which allows for the intradermal delivery of living cells in a minimally invasive manner.
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Cell-based seasonal influenza vaccine safe and effective in children
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
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EMA to assess if Olumiant should be authorised for hospitalised COVID-19 patients
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
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COVID-19 manufacturing requirements are lucrative for CMOs, says GlobalData
A new report shows half the drugs and all the vaccines approved for emergency use in 2020 had an associated contract manufacturing agreement.
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Novel vaccine 77 percent effective in preventing malaria, finds study
The R21 vaccine candidate, when administered with 50mg of adjuvant, was found to be 77 percent effective in preventing malaria in children over 12 months.
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EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-300x278.jpg)
![Two vials labelled 'Janssen COVID-19 Vaccine' [Credit: oasisamuel/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Janssen-COVID-19-Vaccine-e1619436264802.jpg)
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Janssen COVID-19 Vaccine approved for continued use in US
The US FDA and CDC have confirmed that the single-shot COVID-19 vaccine’s benefits continue to outweigh the risks of clotting and have given approval for its use to resume.
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Adding vesicles to cell-free gene expression (CFE) systems increases yield
Enriching cell-free gene expression system extracts with membrane bound vesicles can significantly increase their ability to produce protein-based products, shows study.
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Cleanroom infrastructure innovation to fulfil the needs of cell and gene therapies
Biopharmaceuticals have transformed the patient care landscape, but alongside this step change in treatment capability comes the need for a similar paradigm shift in manufacturing capability. Here, Maik W Jornitz, President & CEO of G-CON Manufacturing Inc. highlights how cleanroom infrastructure must develop to keep pace with ever evolving industry needs.
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COVID-19 vaccine rollout: a logistics success story
The dedication of the science community and healthcare workers in the fight against COVID-19 has been unwavering and justly praised. Yet logistics workers and the industries that support it have also achieved tremendous feats to support the resulting aid. Here, Zoe McLernon, Multimodal Policy Manager at Logistics UK, highlights the…
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Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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NICE recommends ravulizumab for treatment of a rare blood disorder
On the NICE’s recommendation, ravulizumab will be made available to hundreds of patients with paroxysmal nocturnal haemoglobinuria on the UK’s NHS.
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Inactivated COVID-19 vaccine candidate enters comparative immunogenicity trial
The Phase III trial aims to demonstrate that Valneva’s VLA2001 is more immunogenic than AstraZeneca's conditionally approved COVID-19 vaccine, Vaxzevria.
