Johnson & Johnson Archives - Page 31 of 33

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.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” Janssen R&D global head Dr. Mathai Mamment said in a news release. “Changing the trajector…

Johnson & Johnson gearing up for COVID-19 vaccine data announcement

Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week.

In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details.

“We think it’s very important to follow the data — to follow the science,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.

[Related: Johnson & Johnson pharma sales drive Street-beating Q4 results]

If the company’s adenovirus-based vaccine performs in the same league as those from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE), Ad26 could play a vital role in stemming the COVID-19 crisis. Unlike competitors’ vaccines, Ad26 could be offered in a single dose, potentially simplifying mass-vaccination efforts.

Former Operation Warp Speed chief Moncef Slaoui suggested that Ad26 vaccine…

Verana Health to collaborate with Janssen on ophthalmology and urology research

Verana Health (San Francisco), which has expertise in turning clinical data into real-world evidence, announced today that it has inked a research collaboration agreement with Johnson & Johnson‘s Janssen Research & Development.

The research with Janssen will have an ophthalmology and urology focus.

In the ophthalmology space, Verana Health will analyze the American Academy of Ophthalmology’s IRIS registry data to characterize baseline patient attributes, disease progression, and treatment-based outcomes for people treated for diabetic macular edema, a complication of diabetes that impacts 750,000 Americans and may lead to severe vision loss.

The urology research will focus on early-stage prostate cancer. The first phase of the pilot will involve curating and evaluating de-identified data from a small subset of patients in the American Urological Association Quality (AQUA) registry.

“Characterizing early-stage prostate cancer ha…

Johnson & Johnson pharma sales drive Street-beating Q4 results

Johnson & Johnson (NYSE:JNJ) posted fourth-quarter results today that beat the consensus forecast on Wall Street — with the company predicting a return to strong sales growth in 2021.

The New Brunswick, N.J.–based pharma, medical device and consumer products giant reported profits of $1.7 billion, or 65¢ per share, on sales of $22.5 billion for the three months ended Dec. 29, 2020, for a bottom-line decline of –56.7% on sales growth of 8.3% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were $1.86, 4¢ ahead of The Street, where analysts were looking EPS of $1.82 on sales of $21.7 billion.

Investors reacted by sending JNJ shares up 2.6% to $1.70 apiece today in morning trading.

Pharma business sales were up 16.3% year-over-year, to $12.3 billion, in Q4, driving overall growth. Drugs driving the revenue growth treated diseases ranging from Crohn’s disease to cancer to hypertension.

Get the full story o…

Johnson & Johnson pharma sales drive Street-beating Q4 results

Johnson & Johnson (NYSE:JNJ) posted fourth-quarter results today that beat the consensus forecast on Wall Street — with the company predicting a return to strong sales growth in 2021.

The New Brunswick, N.J.–based pharma, medical device and consumer products giant reported profits of $1.7 billion, or 65¢ per share, on sales of $22.5 billion for the three months ended Dec. 29, 2020, for a bottom-line decline of –56.7% on sales growth of 8.3% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were $1.86, 4¢ ahead of The Street, where analysts were looking EPS of $1.82 on sales of $21.7 billion.

CEO Alex Gorsky said in a news release that the company is leading in the fight against COVID-19.

“We continue to progress our COVID-19 vaccine candidate and look forward to sharing details from our Phase 3 study soon,” Gorsky said. “Johnson & Johnson was built for times like these, and I am extremely confi…

The U.S. COVID-19 vaccine rollout continues to lag but is accelerating

Photo by Thirdman from Pexels

Some 20.5 million doses of COVID-19 vaccines have been administered as of Jan. 23 — roughly in line with the CDC’s end-of-2020 goal.

The pace of vaccination as of the morning of Jan. 21 was roughly 1 million, about four-fifths involving initial doses of the two-dose vaccine.

For the sake of comparison, COVID-19 tests were 1.9 million on the same day.

At the current vaccination rate, vaccinating the majority of Americans could occur by January 2022, according to an analysis from The Wall Street Journal.

It is likely, however, that the pace will continue to quicken as a growing number of organizations become involved in administering shots. Johnson & Johnson’s (NYSE:JNJ) could also file for emergency use authorization for a single-dose vaccine as early as February.

At present, UBS estimates that 4.6% of the U.S. population has received at least…

Johnson & Johnson vaccine trial results expected soon

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon.

The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.

Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”

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

Johnson & Johnson vaccine trial results expected soon

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon.

The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.

Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”

J&J published interim phase 1/2a data from its vaccine trial in the New England Journal of Medicine last week, with the data demonstrating that the single-dose vaccine candidate provided an immune response that l…

DePuy Synthes lands FDA clearance for Velys robotic knee system

Image from Depuy Synthes/Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it received FDA 510(k) clearance for the Velys system.

Velys is a robotic-assisted system designed for use with the Attune total knee system and its cleared indications for use and it will become part of the broader Velys digital surgery platform of connected technologies, according to a news release.

DePuy Synthes touts the Velys robotic-assisted platform as a first-of-its kind, table-mounted solution with an efficient design capable of integrating into any operating room. The company said it adapts to a surgeon’s workflow, offers control they are used to and heps execute accurate bony cuts.

Additionally, the Velys system offers gap balance data for visualization and joint stability predictions, along with accurate, consistent plan execution supporting the Attune total knee system.

Johnson & Johnson and DePuy Synthes acquire…

Medtechs can’t set digital strategies aside – DTW Podcast

Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck.

In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices:

Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical, says new medtech tools must be connected to provide maximum benefit. In a separate interview on the podcast, Mark Toland, the former CEO of Corindus Vascular Robotics, says medtech companies moving into the surgical robotics space are advancing the model by building digital infrastructures around the surgical system. “Now they’re thinking about the data integration work, they’re thinking about how that translates into artificial intelligence over time,” he said. Also in this podcast, Kal Patel, the CEO and co-founder of BrightInsight, shares the insight he’s bringing to medtech from his pas…

Ex-Acclarent execs fined $1.5M in off-label marketing case

[Image from Unsplash]There will be no prison time for the two former Acclarent executives convicted of federal misdemeanor charges related to marketing a sinus balloon catheter for unapproved uses.

Former Acclarent CEO William Facteau will instead pay a $1 million fine, and the company’s ex-sales VP Patrick Fabian will pay $500,000, according to the sentence handed down yesterday by U.S. District Judge Allison Burroughs in Massachusetts.

The case goes back a decade and involves accusations that Facteau and Fabian improperly marketed the device leading up to Johnson & Johnson’s $785 million acquisition of the company in 2010.

Burroughs apologized to the two men that it took more than four years after their convictions for them to receive a sentence — also saying that the fines were enough punishment for their “crime of greed,” according to a report from Reuters.

Facteau has been CEO of hearing tech company Earlens since 20…

Medtech takes a stand on D.C. rioting

The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump.

The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end to the violence and for a peaceful transition of power to President-elect Joe Biden’s administration.

Get the full story on our sister site, Medical Design & Outsourcing.