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COVID-19 Vaccine Moderna update
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
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Biologics
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Cosentyx® reduces risk of juvenile idiopathic arthritis flares by 72 percent
Data from the Phase III JUNIPERA trial shows more patients with juvenile idiopathic arthritis achieved and maintained improvements in joint symptoms with Cosentyx® (secukinumab).
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Application note: Resilient plastics in the Cold Chain
Pictorial that explains how Aramus TM single-layer fluoropolymer bag can withstand gamma irradiation and cold-chain temperatures down to -196°C.
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First-in-human universal flu vaccine trial begins
The US National Institutes of Health have begun a first-in-human trial to assess the safety and immunogenicity of a potential universal influenza vaccine candidate, FluMos-v1.
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Cilta-cel induces deep and durable responses in relapsed or refractory multiple myeloma trial
New trial data shows 98 percent of heavily pre-treated relapsed/refractory multiple myeloma patients responded to Janssen’s ciltacabtagene autoleucel (cilta-cel).
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WHO lists the Sinovac-CoronaVac COVID-19 vaccine emergency use
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
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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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Vaccine slows loss of insulin production in type 1 diabetes genetic subgroup
In a Phase II trial, injecting GAD-alum into the lymph nodes of newly diagnosed type 1 diabetes patients with a genetic variant slowed insulin production degradation.
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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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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).
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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.
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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.
