Johnson & Johnson Archives - Page 19 of 33

Johnson & Johnson to ask FDA to authorize COVID-19 booster

Johnson & Johnson’s Janssen division (NYSE:JNJ) is planning on requesting expanding the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters.

The previous EUA covered a single dose of the vaccine.

Despite its initial advantage as a single-dose vaccine, Ad26.COV2.S has failed to match the popularity of the mRNA vaccines from Pfizer and Moderna.

Authorities in the U.S. and EU have linked the vaccine to extremely rare blood clotting episodes. And recently, officials at the European Medicines Agency found another possible link between the vaccine and clotting in deep veins in Ad26.COV2.S recipients, Reuters reported.

A recent CDC study found that a single dose of the Janssen vaccine was 71% effective in preventing hospitalization from COVID-19. By contrast, the two-dose Moderna and Pfizer-BioNTech vaccines were 93% and 88% effective, respectively.

Janssen said an additional dose of Ad26.COV2.S vaccine b…

AdvaMed supports effort to overturn J&J pelvic mesh ruling in California

Medical device trade group AdvaMed announced today that it has filed an amicus curiae brief supporting an appeal to overturn a $344 million pelvic mesh ruling against Johnson & Johnson in California.

Lawyers for AdvaMed tell the California Court of Appeal that the San Diego Superior Court judgment violated safe harbor protections because the case involved J&J communications about pelvic mesh that were FDA-approved.

“We believe the trial court misapplied California’s Unfair Competition Law and Fair Advertising Law by failing to judge the communications from the perspective of the target audience — trained physicians who treat pelvic floor conditions — over 80 of whom confirmed that the marketing materials were not likely to mislead them,” said Pat Fogarty, AdvaMed’s SVP, deputy general counsel and director of litigation.

“The decision undermines a manufacturer’s ability to rely on FDA input when it comes to the adequacy of …

COVID-19 vaccines remain a cash cow for now

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of $1.1 billion in the first half of this year, according to Moody’s.

Analysts are divided, however, on how strong vaccine sales will be in 2022 and beyond.

A report from Moody’s predicts that vaccine sales next year will begin to wane given significant vaccine penetration rates and uncertain demand for boosters. Vaccine penetration rates in many G20 countries have already surpassed 60%. As a result, COVID-19 vaccine revenue i…

CDC study finds waning immunity in Pfizer-BioNTech vaccine recipients after four months

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions.

The CDC concluded that, from March 11 to August 15, the Moderna vaccine was 93% effective. The Pfizer-BioNTech and Janssen vaccines had lower effectiveness rates of 88% and 71%, respectively. The research also found that post-vaccination anti-spike IgG and anti-RBD IgG antibodies levels were “significantly lower” for Janssen vaccine recipients than those who received mRNA vaccines

Drawing data from more than 3,600 adults, the study interpreted vaccine efficacy as protection against hospitalization.

The report noted that all three COVID-19 vaccines available in the U.S. prevented hospitalization based on data from 21 hospitals.

The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that inte…

Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures again delayed due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Global Healthcare Conference.

Get the full story at our sist…

Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]

Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures delayed again due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Globa…

European regulators offer positive opinion on Janssen’s schizophrenia treatment

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation covers clinically stable adults on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.

Get the full story at our sister site, Drug Delivery Business News.

European regulators offer positive opinion on Janssen’s schizophrenia treatment

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion to recommend the use of long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia in adults who are clinically stable on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.

Get the full story at our sister site, Drug Delivery Business News.

Johnson & Johnson seeks nominees for women STEM scholars awards

Johnson & Johnson (NYSE:JNJ) announced that it is accepting applications for its 2022 Women in STEM2D (WiSTEM2D) Scholars Award.

New Brunswick, N.J.–based Johnson & Johnson’s award aims to support assistant or associate academic professors in the disciplines of science, technology, engineering, math, manufacturing and design through three years of mentorship from leaders at the company and a total of $150,000 ($50,000 each year), according to a news release.

Get the full story at our sister site, MassDevice.

Johnson & Johnson seeks nominees for women STEM scholars awards

Johnson & Johnson (NYSE:JNJ) announced that it is accepting applications for its 2022 Women in STEM2D (WiSTEM2D) Scholars Award.

New Brunswick, N.J.-based Johnson & Johnson’s award aims to support assistant or associate academic professors in the disciplines of science, technology, engineering, math, manufacturing and design through three years of mentorship from leaders at the company and a total of $150,000 ($50,000 each year), according to a news release.

The company launched the Johnson & Johnson WiSTEM2D Scholars Award in June 2017 in an effort to fuel the development of female STEM2D leaders and inspire career paths in STEM2D by supporting the research of the awarded women in their respective fields.

An independent external advisory board will select the 2022 winners, each of whom will go on to represent one of the STEM2D disciplines.

“COVID-19 has shown us that investment…

J&J says study found it’s investigational HIV vaccine didn’t provide enough protection

Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection.

New Brunswick, N.J.-based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young women in sub-Saharan Africa who are at high risk of acquiring HIV, although the vaccine was found to have a favorable safety profile with no serious adverse events.

The Imbokodo vaccine regimen was administered to participants through four fascination visits over one year, with primary analysis conducted at 24 months following the first vaccination. The study found that 63 of 1,109 participants who received placebo, compared to 51 of 1,079 participants who received active vaccine, acquired HIV. The analysis demonstrated a vaccine efficacy point estimate of 25.2%.

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MedTech 100 roundup: Industry reaches another high point

The medtech industry is continuing its massive 2021 boom, with the past week marking yet another record in the markets.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 27) at 121.05 points, representing a 1.2% rise from the 119.63-point mark set a week before. Following a slight dip earlier this month, the industry continues to tick up to new heights.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 31.1% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 94.8% ascent above that point.

The industry’s performance fell in line with the overall markets this past week as the S&P 500 I…