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After suspending EUA request, Brazil now shelves import authorisation of Covaxin
expresspharma
July 30, 2021
After suspending the proposed clinical trials of Bharat Bioetch’s COVID-19 vaccine Covaxin and a request for Emergency Use Authorisation, Brazil now has suspended its decision to import four million doses of the jab into that country.
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Anvisa allows import of Covaxin, Sputnik V into Brazil, but conditions apply
expresspharma
June 07, 2021
According to Anvisa's approval, Brazil is expected to receive four million doses of Covaxin initially.
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Sorrento gets Brazilian ANVISA’s clearance for Phase II Covid-19 trial
pharmaceutical-technology
May 24, 2021
Sorrento Therapeutics has received clearance from the Brazilian regulatory agency ANVISA to conduct a Phase II clinical trial of an injectable infusion of mesenchymal stem cells, COVI-MSC, to treat Covid-19 patients with acute respiratory distress ...
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Brazil’s Anvisa rejects import of Russia’s Covid-19 vaccine
pharmaceutical-technology
April 28, 2021
The Brazilian National Health Surveillance Agency (Anvisa) has rejected the import of the Russian Covid-19 vaccine, Sputnik V, citing a lack of consistent and reliable data.
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Anvisa says Covaxin producing facility does not meet CGMP standards
expresspharma
April 01, 2021
The Brazilian health regulator Anvisa has denied permission to import Bharat Biotech’s COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Current Good Manufacturing ...
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Biocon Pharma joins hands with Libbs Farmaceutica to launch generic medicines in Brazil
expresspharma
March 29, 2021
Biocon Pharma will be responsible for drug development and manufacturing of the medicines, while Libbs will import, distribute and market, subject to approvals from ANVISA.
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Anvisa sends back request for EUA of Sputnik V vaccine
expresspharma
January 18, 2021
Anvisa said that Uniao Quimica, the pharma firm applying for EUA of Sputnik V vaccine, failed to provide adequate assurances on its Phase III clinical trials and issues related to the manufacture of the vaccine.
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Bharat Biotech signs deal with Precisa Medicamentos for COVAXIN supply to Brazil
expresspharma
January 13, 2021
Supplies will be prioritised for the public market through a direct procurement by the Government of Brazil, private market will get the vaccine after receipt of market authorisation from ANVISA.
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Brazil authorises resumption of Johnson & Johnson’s Covid-19 vaccine trial
pharmaceutical-technology
November 05, 2020
The Brazilian Health Surveillance Agency Anvisa has granted approval to Johnson & Johnson (J&J) for resuming a clinical trial of its experimental Covid-19 vaccine in the country.
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Brazil volunteer in AstraZeneca COVID-19 vaccine trial dies, trial to go on
expresspharma
October 22, 2020
Sources say that the trial would have been suspended if the volunteer who died had received the COVID-19 vaccine, suggesting the person was part of the control group that was given a meningitis jab.