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Janssen Biotech Inc.

http://www.janssenbiotech.com

Latest From Janssen Biotech Inc.

US FDA Still Discussing Ideas For Pediatric Development Of COVID-19 Vaccines

J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.

Coronavirus COVID-19 Pediatrics

BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

Drug Approval Standards Clinical Trials

When A Single Shot Is A Problem: J&J’s Study Of Two Doses Raises Equality, Distribution Questions

FDA and CDC advisory committee members wonder how to use the single-shot J&J vaccine if an ongoing study shows two doses are better than one.

Coronavirus COVID-19 Vaccines

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

Vaccines Coronavirus COVID-19
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