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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
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Phase III COVID-19 antibody trials initiated in Americas
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
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Cervical dysplasia treatment device approved for global Phase III trial
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
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Long-acting injectable HIV PrEP outperforms commercially available daily pill
Extensive analysis of interim data finds patients given cabotegravir injection had a 66 percent lower incidence of HIV acquisition than those taking Truvada pills.
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How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
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US trial testing Kevzara® (sarilumab) as a COVID-19 treatment stopped
Companies leading trial announce Kevzara failed to meet primary and secondary endpoints in critically ill COVID-19 patients, so the trial has been halted.
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First COVID-19 vaccine given green light for Phase I trial in China
CanSino Biologics' Ad5-nCoV vaccine, a potential COVID-19 prophylactic, has been approved for study in a Phase I clinical trial in China.
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First COVID-19 vaccine clinical trial approved in India
Indian authorities have given the green light to test Bharat Biotech's COVID-19 vaccine in Phase I and Phase II clinical trials.
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NICE does not recommend Novartis’ siponimod for secondary progressive MS
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
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Comparison of new vaccine approaches – COVID-19
The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
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EMA recommends authorisation for remdesivir to combat COVID-19
The EMA's human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
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Over 2,000 clinical trials currently underway for COVID-19 therapies, finds study
New findings have revealed that over 2,000 clinical trials are being conducted to test COVID-19 therapies while 583 companies are involved in treatment and vaccine development.
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First patient dosed with COVID-19 vaccine using self-amplifying RNA
A Phase I clinical trial to test Imperial College London's COVID-19 vaccine candidate has been initiated, with the first patient dosed.
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Inhaled formulation of remdesivir to be tested as COVID-19 treatment
Gilead Sciences has said it will initiate clinical trials in August to test an inhaled formulation of remdesivir, a potential COVID-19 therapy.
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Ruxolitinib to be studied as COVID-19 treatment in clinical trial
Following the successful treatment of a COVID-19 patient with ARDS using ruxolitinib, Germany is set to begin clinical trials to test the drug.