register

News & Trends - Pharmaceuticals

J&J to resume phase 3 trial of its Janssen COVID-19 vaccine

Health Industry Hub | October 26, 2020 |

Pharma News: Johnson & Johnson announced that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.

The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing.

After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.

At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safety, well-being and privacy of the participants and all those involved in our trials.

Janssen is committed to respecting study participant privacy and the integrity of the clinical trial in which the study investigator and the participant are intentionally not informed (remain “blinded”) as to whether this participant received the vaccine candidate or placebo.

Clinical trials are designed to evaluate safety and efficacy based on a complete view of all participants and their experiences. Unexpected adverse events, including illnesses, can occur in study participants during any clinical study, especially large studies; they can occur in both vaccine and placebo groups and require evaluation. The full safety and efficacy results will be shared at the conclusion of the trial when we can present a complete assessment of the profile of our vaccine candidate to regulatory authorities for consideration.

In accordance with the clinical trial protocol and regulatory requirements, the Janssen study team remains blinded. This is to maintain the integrity of the data, which is essential to establish the safety and efficacy of the vaccine candidate.


News & Trends - Pharmaceuticals

Is the government is gearing up to release the long-awaited response to The New Frontier report?

Government’s long-awaited response to The New Frontier report unveiled after two-year wait

Health Industry Hub | December 1, 2023 |

Pharma News: The Albanese Government has tabled its response to the House of Reps inquiry and The New Frontier report […]

More


News & Trends - Pharmaceuticals

Gilead welcomes HIV Taskforce report and celebrates the 'unsung heroes'

Gilead welcomes HIV Taskforce report and celebrates the ‘unsung heroes’

Health Industry Hub | December 1, 2023 |

Pharma News: On World AIDS Day, the National Association of People with HIV Australia (NAPWHA) and Gilead Sciences Australia have […]

More


News & Trends - Pharmaceuticals

AbbVie secures PBS listing of first therapy for Crohn's disease in seven years

AbbVie secures PBS listing of first therapy for Crohn’s disease in seven years

Health Industry Hub | December 1, 2023 |

Pharma News: AbbVie’s Rinvoq (upadacitinib), a once-daily tablet, has been officially listed on the Pharmaceutical Benefits Scheme (PBS) for adult […]

More


ESG

New report calls on policy integration of sustainability in medical device and pharmaceutical registrations and funding

New report calls on policy integration of sustainability in medical device and pharmaceutical registrations and funding

Health Industry Hub | November 30, 2023 |

ESG: Increasing pressures from diverse stakeholder groups, spanning policymakers, investors, customers, and employees, have elevated Environmental, Social, and Governance (ESG) […]

More


This content is copyright protected. Please subscribe to gain access.