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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 primary and key secondary endpoints, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

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 primary and key secondary endpoints, according to a news release.

The company expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.

READ: Which companies will likely produce the most COVID-19 vaccine i…

J&J starts clinical trial on vaccine candidate after strong non-human results

Johnson & Johnson (NYSE:JNJ) announced that its lead SARS-CoV-2 vaccine candidate protected against infection of the virus causing COVID-19 in pre-clinical studies.

New Brunswick, N.J.-based J&J published data in Nature that showed the company’s investigational adenovirus serotype 26 (Ad26), vector-based vaccine elicited a robust immune response with “neutralizing antibodies” to prevent subsequent infection and provide complete or near-complete protection in the lungs from the virus in non-human primates.

Researchers immunized the non-human primates with a panel of vaccine prototypes before challenging them with SARS-CoV-2 infection. Of seven vaccine prototypes tested, Ad26.COV2.S elicited the highest level of neutralizing antibodies, which correlated with the level of protection, confirming early suggestions that they could be a potential biomarker for vaccine-mediated protection.

The six non-human primates that received a sing…

The most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…

The 26 most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…