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The current limitations facing biosimilar products and manufacturers
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
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Biologics
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Tremfya® improves psoriatic arthritis joint function and skin clearance
Over 50 percent of psoriatic arthritis patients treated with Tremfya® (guselkumab) achieved ≥20 percent improvement in joint symptoms and complete skin clearance at one year.
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Tislelizumab reduces risk of death by 30 percent in oesophageal cancer trial
In a Phase III trial, Novartis’ investigational checkpoint inhibitor tislelizumab improved overall survival in patients with oesophageal squamous cell carcinoma.
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100 Days Mission: “landmark collaboration” to protect people against future pandemics
Governments and life science leaders agree to work towards slashing the time to develop and deploy interventions and diagnostics for future pandemic threats to 100 days.
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US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
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Risankizumab induces deep remissions in Crohn’s disease trial
Phase III trial data shows more than half of patients with moderate to severe Crohn's disease treated with risankizumab (Skyrizi®) 360mg achieved clinical remission in a year.
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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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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.
