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Avet recalls tetracycline HCl capsules to consumer level
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
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Bioprocessing & Bioproduction In-Depth Focus 2020
The articles in this in-depth focus discuss the importance of biosimilars and how liquid chromatography can be used to ensure the purity of lipid-based nanoparticles for drug delivery.
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BARDA to give Moderna up to $483 million for COVID-19 vaccine development
The US Biomedical Advanced Research and Development Authority (BARDA) will fund Moderna’s COVID-19 vaccine candidate mRNA-1273 through Phase II and III clinical trials to FDA licensure.
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Trial finds lopinavir/ritonavir and Arbidol ineffective for mild-to-moderate COVID-19
A Phase IV trial in 86 patients with mild-to-moderate COVID-19 has indicated that lopinavir/ritonavir (LPV/r) and Arbidol do not improve clinical outcomes.
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‘Cocktail’ of pharmaceuticals identified in Bangladeshi waters
A study of both city and rural water sources identified antimicrobials at every site and suggests the contamination could be causing the emergence of treatment-resistant microbes.
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NICE recommends Vitrakvi (larotrectinib) for use on Cancer Drugs Fund
Larotrectinib has been given a positive opinion by NICE, following the submission of a revised price after it was previously rejected.
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European Pharmaceutical Review Issue 2 2020
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
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UK national priority COVID-19 trial now recruiting patients
The PRINCIPLE trial aims to evaluate therapeutics that could slow the progression of COVID-19 symptoms in patients most at risk of complications.
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IND submitted for opaganib, potential COVID-19 treatment
RedHill Biopharma has submitted its Investigational New Drug application for its drug opaganib, for the treatment of COVID-19, to the FDA.
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FDA approves first generic albuterol sulfate metered dose inhaler
The generic Proventil HFA (albuterol sulfate) metered dose inhaler has been approved for the prevention of bronchospasm in patients four years of age and older.
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Production of Avigan® Tablet (favipiravir) accelerated for use against COVID-19
FUJIFILM intends to accelerate production of Avigan to 100,000 treatment courses per month by July and up to 300,000 by September 2020 to meet demand for possible use treating COVID-19.
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Eli Lilly’s COVID-19 therapies to enter clinical trials
The enterprise announced its drug OLUMIANT® (baricitinib) and an investigational antibody will enter clinical trials in US COVID-19 patients later this month.
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Novel cannabinoid formula could be used as a cancer treatment
The developers of the novel formulation, containing the cannabinoids CBDV and CBGA, now intend to test the clinical safety and efficacy of its anti-cancer activity.
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Clinical trials for COVID-19 treatments show mixed results, says study
Despite some positive results from clinical trials for COVID-19 treatments, separate tests of the same therapies have not met primary endpoints.
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EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
