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EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
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First patient treated with potentially curative HIV cell and gene therapy
The first-in-human study will evaluate the safety and efficacy AGT103-T, a cell and gene therapy product for HIV, in up to six participants.
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UK approves Janssen COVID-19 Vaccine
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.
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FDA approves sotrovimab for emergency use in treating COVID-19
The FDA granted emergency use authorisation to the monoclonal antibody sotrovimab as a treatment for mild-to-moderate COVID-19 in certain adult and paediatric patients.
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Researchers may know the cause of COVID-19 vaccine related blood clots
Investigators at the Goethe University of Frankfurt believe that post-transcriptional modifications may be causing the clotting problems associated with recombinant vector COVID-19 vaccines.
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First patient dosed with multi-variant second-generation COVID-19 vaccine
The first-in-human trial of OSE Immunotherapeutics’ multi-variant, second-generation COVID-19 vaccine has enrolled and dosed its first participant.
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Moderna’s COVID-19 vaccine 93 percent effective in adolescents
New Phase II/III study data shows Moderna’s COVID-19 vaccine is safe and immunogenic in patients aged 12 to less than 18 years old.
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
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Global nebulisers market to decline after COVID-19
As the world recovers from COVID-19, research suggests the nebuliser devices market will initially shrink before recovering and reaching a value of $1.55 billion in 2025.
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Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
A new report suggests pharma is working hard to combat worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.
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Stem cell therapy shows promise in COVID-19 respiratory distress
JadiCell™ was shown to significantly improve survival in COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) and also reduce lung scarring associated with long-COVID-19.
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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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CDMO sector are the big winner of the pandemic, state experts
In a presentation, experts revealed that contract services gained significantly through pandemic contracts but cautioned that capacity shortages could continue.
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Are COVID-19 vaccines effective for immunocompromised patients with haematological malignancies?
A new study will evaluate COVID-19 vaccines in patients with haematological malignancies who have received cellular therapy.
