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MHRA approve first monoclonal antibody treatment for COVID-19
The MHRA have approved Ronapreve as the first monoclonal antibody combination product for the treatment of COVID-19 infection in the UK.
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Therapeutics
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Meeting the challenge of cost-effective OTC drug manufacture with powder testing
Sharper manufacturing practice is often essential to rigorously optimise production economics and compete effectively in the over-the counter (OTC) marketplace. This article describes the application of powder testing to improve the manufacturing efficiency of OTC products detailing work by Pfizer and GlaxoSmithKline (GSK), companies with extensive OTC portfolios.
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Atogepant significantly reduces migraines, shows study
A 12-week study revealed that atogepant reduced migraines and headaches and resulted in a 50 percent reduction in mean monthly migraine days.
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Study shows no benefit of convalescent plasma for COVID-19 patients
An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.
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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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Moderna announces first patient dosed in mRNA-3705 study
Moderna have announced that the first patient has been dosed in Phase I/II study of mRNA-3705 for methylmalonic acidemia (MMA).
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Machine learning boosts spirulina bioproduction by up to 100 percent
Collaborating with Google, Lumen Bioscience applied Bayesian black-box optimisation, a machine learning approach, to increase spirulina biomanufacturing productivity.
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Partnership to stabilise essential medicines supply with synthetic biology
Under a new collaboration, Antheia will use Ginkgo Bioworks’ cell programming platform to expand the capabilities of its whole-cell engineered pharmaceutical production pathways.
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Low-cost plant-derived COVID-19 vaccine to be developed for developing countries
Researchers are developing a low-cost plant virus based COVID-19 vaccine to be produced in Botswana for pandemic prevention in developing countries.
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FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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New NICE draft guidance recommends abemaciclib for breast cancer
NICE has published draft guidance recommending Eli Lilly's twice-daily pill abemaciclib for advanced HER2-negative breast cancer.
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Advances in technology and manufacturing to promote plant-produced therapeutics uptake
Experts suggest investing in plant-based manufacturing systems could reduce costs and help scale up therapeutic protein manufacturing.
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ebook: Waiving intellectual property rights for COVID-19-related interventions and technologies: a comprehensive guide
This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
