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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
europeanpharmaceuticalreview
May 11, 2021
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
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Janssen seeks EU approval for first CAR-T therapy cilta-cel
pharmatimes
May 07, 2021
Johnson & Johnson’s (J&J) pharma division Janssen has filed its first CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) with the European Medicines Agency (EMA), seeking approval for the treatment of patients with relapsed/refractory multiple ...
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
europeanpharmaceuticalreview
April 22, 2021
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
worldpharmanews
April 14, 2021
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after ...
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Highlights of the EMA’s drug safety committee April meeting
europeanpharmaceuticalreview
April 14, 2021
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
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J&J expands Phase 2a COVID-19 vaccine trial to include adolescents
expresspharma
April 06, 2021
Johnson & Johnson has begun vaccinating adolescent participants in the ongoing Phase 2a clinical trial for its COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
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Cidara Therapeutics signs deal with Janssen for antiviral conjugates to prevent, treat influenza
expresspharma
April 06, 2021
Cidara Therapeutics announced that it has entered into an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals to develop and commercialise Cidara’s Cloudbreak antiviral conjugates (AVCs) for the prevention and ...
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Johnson & Johnson Announces Advance Purchase Agreement with the African Vaccine Acquisition Task Team for the Company's COVID-19 Vaccine Candidate
prnasia
March 29, 2021
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into an agreement with the African Vaccine Acquisition Task Team (AVATT) to make available up to 220 million doses of its single-shot COVID-19 ...
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Catalent Expands Partnership with J&J
contractpharma
March 18, 2021
Catalent Pharma Solutions has expanded its partnership with Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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J&J single-shot COVID-19 vaccine gets Emergency Use Listing by WHO
expresspharma
March 15, 2021
Data have demonstrated vaccine protects against COVID-19 related hospitalisation and death in broad geographic regions, including those with variants of significant concern.