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EMA approves fourth Covid-19 vaccine, J&J’s single-shot candidate
pharmaceutical-technology
March 12, 2021
The European Medicines Agency (EMA) has recommended conditional marketing authorisation for Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine.
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J&J gets positive CHMP opinion for single-shot COVID-19 vaccine candidate
expresspharma
March 12, 2021
If granted conditional marketing authorisation by the EC, the J&J single-shot COVID-19 vaccine will be available in the EU.
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Johnson & Johnson announces aingle-ahot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of its Phase 3 ENSEMBLE trial
worldpharmanews
March 09, 2021
Johnson & Johnson announced top line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key ...
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Health Canada authorises J&J’s Covid-19 vaccine for emergency use
pharmaceutical-technology
March 09, 2021
Health Canada has authorised an Interim Order (IO) to the Janssen Pharmaceutical (JPI) Companies of Johnson & Johnson’s (J&J) single-shot vaccine preventing Covid-19 for people aged 18 above.
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FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
americanpharmaceuticalreview
March 02, 2021
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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FDA authorises emergency use of Janssen’s single shot Covid-19 vaccine
pharmaceutical-technology
March 02, 2021
The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s single-dose Covid-19 vaccine.
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J&J Announces Single-Shot Janssen COVID-19 Vaccine Candidate Submission to WHO
americanpharmaceuticalreview
February 23, 2021
Johnson & Johnson announced Janssen-Cilag International has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate.
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Janssen-Cilag seeks EMA authorisation for Covid-19 vaccine candidate
pharmaceutical-technology
February 19, 2021
Johnson & Johnson’s (J&J) Janssen-Cilag International has announced it applied to the European Medicines Agency (EMA) to obtain authorisation for its Covid-19 vaccine candidate.
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Erleada drug combination extends progression-free survival in prostate cancer trial
europeanpharmaceuticalreview
February 10, 2021
In the Phase III ACIS study, prostate cancer patients treated with a combination of Erleada® and Zytiga® plus prednisone were less likely to die than participants receiving Zytiga and prednisone.
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EU approves expanded use of Janssen’s Spravato
pharmatimes
February 09, 2021
The European Commission (EC) has approved the expanded use of Janssen’s Spravato for the rapid reduction of depressive symptoms in a psychiatric emergency, for adult patients with a moderate-to-severe episode of major depressive disorder (MDD).