Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime […]
Janssen Pharmaceuticals
U.K. authorizes J&J COVID-19 vaccine
The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a […]
Pharma 50: Here’s how the world’s largest pharma companies are doing
The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data […]
How PhysIQ is advancing digital therapeutics through its partnership with Janssen
A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform. Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, […]
FDA, CDC lift pause on J&J COVID-19 vaccine
The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the […]
PhysIQ, Janssen partner on digital therapeutics
PhysIQ announced today that it is collaborating to license its AccelerateIQTM platform with Janssen Pharmaceuticals. Chicago-based PhysIQ’s AccelerateIQTM will be licensed to Janssen, a Johnson & Johnson unit so it can deploy it to collect data across its clinical studies through a range of its wearable biosensors, while also utilizing PhysIQ’s portfolio of FDA-cleared digital […]
Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says
The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots. At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that […]
FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]
J&J applies for COVID vaccine approval in Europe
Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on […]
Johnson & Johnson applies for vaccine approval from FDA
Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its […]
