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NICE initiates new Innovative Licensing and Access Pathway for medicines
The new pathway developed by NICE for medicines to go from clinical trials to NHS patients is now in action.
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Therapeutics
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Trial to evaluate monoclonal antibody therapy for mild-to-moderate COVID-19
The study will determine if the combination of BRII-196 and BRII-198, two investigational antibodies for SARS-CoV-2, can prevent disease progression.
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FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
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First long-acting HIV treatment approved in Europe
The European Commission approval of the long-acting injectable HIV treatment could transform the lives of people living with the disease.
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Seven secret ingredients for successfully launching and commercialising a biopharma’s first drug in Europe
After the US, Europe is considered the second most attractive market for serving patient needs while realising commercial value from innovative drugs. However, the 27 EU member states each have their own approaches to pricing and market access – and need tailored commercialisation and go-to-market strategies. Simon-Kucher & Partners analysed…
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First hospitalised COVID-19 patient dosed in FSD201 treatment trial
The study will evaluate whether FSD201 is safe and of benefit to hospitalised patients with COVID-19, in combination with standard of care.
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Pioneering a full-ecosystem microbiota approach to improve survival outcomes in life-threatening diseases
The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…
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AstroRx® shows promise in early phase amyotrophic lateral sclerosis trial
Amyotrophic lateral sclerosis (ALS) patients treated with AstroRx® had a 45 percent reduction in their disease progression rate.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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COVID-19 challenge trials: is there a compelling ethical argument against?
Ethicist says that, should trials offer the huge benefits and low risks, he finds no compelling ethical objection to challenge trials for COVID-19 vaccines.
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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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Bioprocessing & Bioproduction In-Depth Focus 2020
In this in-depth focus learn about the development and implications of a novel high-throughput method for glycoanalytics and how taking a full-ecosystem approach to microbiome restoration could improve patient survival.
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European Pharmaceutical Review Issue 6 2020
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
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Could newborn stem cells revolutionise cell therapies?
In this article, Dr Jaime Shamonki, Generate Life Science’s CMO, discusses how newborn stem cells derived from umbilical cord tissue could make mesenchymal stem cells less expensive and variable to produce.
