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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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Therapeutics
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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.
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Axi-cel highly effective in patients with advanced non-Hodgkin lymphoma, finds Phase II trial
Investigators report 76 percent of trial participants had a complete response to axicabtagene ciloleucel (axi-cel), despite being resistant to other therapies.
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WHO urges countries to “step up” the fight against malaria
The WHO’s World malaria report suggests the progress in eradicating malaria has slowed due to funding shortages and that COVID-19 disruptions could result in additional deaths.
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
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FDA grants COVID-19 treatment Fast Track designation
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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Trial to compare dexamethasone and baricitinib in hospitalised COVID-19 patients
The fourth iteration of the COVID-19 treatment trial will determine whether remdesivir plus baricitinib or dexamethasone is more effective at promoting recovery from COVID-19.
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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
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AstraZeneca starts COVID-19 prevention trial for immunocompromised patients
The trial will evaluate if the long-acting monoclonal antibody cocktail, AZD7442, can prevent COVID-19 in patients who cannot be vaccinated.
