Tag: Janssen

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

, 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. [1] Moreau P et al. Updated Results From MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x ... Read more

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

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 ... Read more