Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Jan 2, 2022 | Business

, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.


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Canada – Update on Janssen COVID-19 vaccines made with drug substance from Emergent BioSolutions

Jun 13, 2021 | International

Health Canada has completed its quality review of the shipment of Janssen vaccines that are currently in quarantine.

June 11, 2021 | Ottawa, ON | Health Canada

Further to Health Canada’s statement on April 30, 2021, Health Canada has completed its quality review of the shipment of Janssen vaccines that are currently in quarantine. To protect the health and safety of Canadians in response to concerns regarding a drug substance produced at the Emergent BioSolutions facility in Baltimore Maryland, Health Canada will not be releasing the shipment.

The drug substance produced at the Emergent BioSolutions facility was used in the manufacturing of this shipment of Janssen vaccines. The drug substance was manufactured at the time a separate batch of vaccines was contaminated by the components of a different vaccine. Health Canada was unable to determine that this shipment of Janssen vaccines meets the Department’s rigorous quality standards.

To ensure the safety of any future vaccine supply from this facility, Health Canada is planning an onsite inspection, expected to take place this summer. Until this inspection has been completed, Canada will not be accepting any product or ingredients made at this site.

Canadians can be assured that any vaccines will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.