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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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Biologics
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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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Anti-PD-L1 monoclonal antibody shows promise in lung cancer patients
In a Phase III trial sugemalimab meaningfully improved progression free survival in patients with stage III non-small cell lung cancer (NSCLC).
webinar
Variable pathlength spectroscopy for dilution-free concentration measurement in GMP environments
27 May 2021 | By Repligen
Watch this on-demand webinar, where we reviewed VPT and how it can be used in various applications, from protein therapeutics to gene therapy.
whitepaper
Article: Water activity of oral solid dosage products using FMS
This article describes water activity determination of OSD using Frequency Modulation Spectroscopy, with a non-destructive headspace gas analyser.
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International Society for Stem Cell Research (ISSCR) releases new guidelines
The ISSCR has released updated guidelines for stem cell research and clinical translation of stem cell-based therapies.
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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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Talquetamab shows promise in multi-drug refractory multiple myeloma patients
New Phase I data shows 65 percent of triple-class and 83 percent of penta-drug refractory multiple myeloma patients responded to talquetamab.
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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.
whitepaper
Article: Replacing blue dye ingress with gas ingress CCI testing
This article describes headspace gas ingress as a CCI test method, which is increasingly being implemented to replace blue dye.
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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.
