Johnson & Johnson Archives - Page 28 of 33

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard.

In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according to the appeals court panel.

In the case against J&J’s Ethicon, a jury had awarded Elizabeth and Tadeusz Hrymoc $5 million in compensatory damages and $10 million in punitive damages after finding the companies liable for violating New Jersey laws on defective design of their ProLift pelvic mesh and failing to warn patients of product risk.

The jury in the case brought by Mary McGinnis and Thomas Walsh McGinnis found Bard liable for design and failure-to-warn defects under the product liability laws of North Carolina, the plaintiffs’ home state, …

Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.

The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.

Get the full story at our sister site, Pharmaceutical Processing World.

Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.

The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.

Get the full story at our sister site, Pharmaceutical Processing World.

Report: Biden to announce partnership for Merck to make J&J’s COVID-19 vaccine

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.

The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.

According to the report, anonymous officials told The Post that, upon the realization that J&J was behind on vaccine production in the early days of the Biden administration, they began looking for additional manufacturing capacity, landing on Merck as an option after the company was unable to produce its own COVID-19 vaccine.

Merck is set to provide two U.S. facilities for producing J&J vaccine doses, with one offering fill-finish services and the other actually making the vaccine. According to the report, this could potentially double the production capacit…

FDA advisory panel endorses J&J’s single-dose COVID-19 vaccine

The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson for adults 18 and over.

Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.

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

FDA advisory panel endorses J&J’s single-dose COVID-19 vaccine

The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.

Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.

The agency will likely authorize the vaccine quickly.

J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.

While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.

VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some member…

Is J&J’s COVID-19 vaccine linked to ringing in the ears?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

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

4 things to keep in mind ahead of the FDA meeting on J&J vaccine

Tomorrow, an FDA advisory panel will convene to evaluate the Ad26.COV2.S COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ).

The vaccine has a favorable safety profile and significant efficacy after a single dose.

Here are several themes that are likely to be among the topics discussed in the Vaccines and Related Biological Products Advisory Committee meeting.

1. The J&J vaccine uses an adenovirus vector as opposed to mRNA

In contrast to Moderna and Pfizer’s mRNA vaccines, J&J’s vaccine uses a replication-incompetent recombinant adenovirus type 26 as a vector to express the SARS-CoV-2 spike protein.

The Ad26 platform is not new, having been administered to nearly 200,000 people in other vaccine candidates.

AstraZeneca’s COVID-19 vaccine also uses an adenovirus vector, as does the Rusian vaccine Sputnik V.

2. Efficacy is in the ballpark of 67%

The Moderna and Pfizer two-dose vaccines had efficacy rates in the range o…

Is J&J’s COVID-19 vaccine linked to tinnitus?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

Get the full story from Drug Discovery & Development.

Is J&J’s COVID-19 vaccine linked to tinnitus?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

J&J concluded that the tinnitus reports were likely unrelated to the vaccine. The principal investigator in the trial that two of the events were related and the remainder unrelated.

A 21-year-old volunteer involved in an earlier clinical trial for the J&J vaccine developed tinnitus and sudden hearing loss 34 days after receiving the vaccine. The patient recovered 69 days after receiving the injection. Johnson & Johnson also determined that the event was unrelated to the vaccine.

In all, some 43,783 volunteers participated in the Phase 3 trial. A total of 19,630 participants received the Ad26.COV…

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 application for the vaccine developed by its Janssen unit on Feb. 4.

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

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 application for the vaccine developed by its Janssen unit on Feb. 4.

According to the FDA briefing, the J&J vaccine candidate is 66% effective at preventing moderate and severe cases of COVID-19, falling within the administration’s standards for authorization, while it is also safe to use. The vaccine proved to be 85.4% effective in preventing severe cases while completely preventing hospitalizations and deaths. There were seven deaths in J&J’s Ensemble Phase 3 clinical trial, all of which occurred in the placebo group.

Should J&J’s vaccine candidate rec…