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First bronchiectasis patient dosed in Phase III trial to study brensocatib
The first patient with bronchiectasis has been dosed in the Phase III ASPEN study of brensocatib, a reversible inhibitor of dipeptidyl peptidase 1.
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Phase III trial to study familial chylomicronemia syndrome drug initiated
Ionis Pharmaceuticals' Phase III trial to evaluate AKCEA-APOCIII-LRx in patients with familial chylomicronemia syndrome has begun.
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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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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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Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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COVAXX commits to deliver 140 million COVID-19 vaccine doses to emerging markets
The company suggests their experimental COVID-19 vaccine, UB-612, has the features and potential to disrupt the traditional vaccine distribution and supply status quo.
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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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Phase II trial to study anti-COVID-19 mAb CT-P59 completes enrolment
A trial of CT-P59, an anti-COVID-19 monoclonal antibody, has completed its enrolment and will study the treatment against standard-of-care.
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EC approves Opdivo for treatment of oesophageal squamous cell carcinoma
The European Commission has approved Opdivo (nivolumab) to treat oesophageal squamous cell carcinoma after studies showed its clinical benefits compared to chemotherapy alone.
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One of the oldest vaccines could help combat COVID-19
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
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EC approves new meningitis vaccine
MenQuadfi® has been approved for use in individuals 12 months of age and older, based on its safety and immunogenicity in 6,300 trial subjects.
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Sputnik V COVID-19 vaccine over 90 percent effective, interim data shows
Phase III trial interim data has shown that Russia's COVID-19 vaccine candidate, Sputnik V, is 91.4 percent effective.
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Pelareorep-based combination therapy improves glioblastoma patient survival
In a Phase Ib trial, pelareorep with GM-CSF, chemoradiotherapy and temozolomide increased progression-free survival by an average of eight months.
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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.