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Pfizer to seek approval for Covid-19 vaccine candidate next month
pharmaceutical-technology
October 19, 2020
Pfizer has announced plans to submit an application to the US Food and Drug Administration (FDA) seeking approval for its Covid-19 vaccine candidate next month.
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Serum India, Bharat Biotech to test intranasal COVID-19 vaccines post regulatory nod: Dr Harsh Vardhan
expresspharma
October 19, 2020
He clarified that Phase III clinical trial is generally with thousands of participants, sometimes even close to 30,000 to 40,000 participants.
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EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
pharmatimes
October 16, 2020
The European Medicines Agency (EMA) has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the agency’s centralised procedure.
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Russia approves second COVID-19 vaccine
expresspharma
October 16, 2020
The vaccine, developed by the Vector Institute in Siberia, completed early-stage human trials last month but the results have not been published yet and Phase III, trials have not yet begun.
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US FDA authorises phase 1 trial of ImmunityBio’s COVID-19 vaccine candidate hAd5
expresspharma
October 16, 2020
Ongoing development proceeding for oral, inhalational and intranasal administration of hAd5.
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EMA begins rolling review of BNT162b2 COVID-19 vaccine
europeanpharmaceuticalreview
October 16, 2020
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
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Norway to distribute free COVID-19 vaccine to all its inhabitants
expresspharma
October 16, 2020
Norway will provide a vaccine against COVID-19 free of charge to its inhabitants when one becomes available, the government said, and this would become part of the country’s national vaccination programme.
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$12 bn fresh funding from World Bank for COVID-19 vaccines, treatments in developing countries
expresspharma
October 16, 2020
It will include technical support to recipient countries so they can prepare for deploying vaccines at scale.
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Moderna initiates rolling submission for Covid-19 vaccine
pharmaceutical-technology
October 16, 2020
Moderna has initiated a rolling submission to Health Canada for its vaccine candidate against Covid-19, mRNA-1273.
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First patient dosed in COVID-19 vaccine tablet clinical trial
europeanpharmaceuticalreview
October 16, 2020
A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.