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.

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BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

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J&J to acquire Momenta for $6.5B

Johnson & Johnson (NYSE:JNJ) announced today that it entered into an agreement to purchase Momenta Pharmaceuticals (NSDQ:MNTA) for $6.5 billion.

New Brunswick, N.J.-based Johnson & Johnson will pay $6.5 billion in an all-cash transaction for the developer of novel therapies for immune-mediated diseases, according to a news release.

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U.S. to spend $1B for doses of J&J’s COVID-19 vaccine candidate

The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for a vaccine candidate from Johnson & Johnson (NYSE:JNJ).

HHS and DoD announced the agreement with Janssen Pharmaceutical, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of its COVID-19 vaccine candidate, with the federal government owning 100 million doses of the vaccine.

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J&J accelerates development of its COVID-19 vaccine candidate

Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September.

“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” said Dr. Paul Stoffels, J&J’s chief scientific officer.

“Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” Stoffels said.

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