Johnson & Johnson Archives - Page 24 of 33

FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Following a safety review that included two meetings of the CDC’s Advisory Committee on Immunization Practices, the pause was lifted on Friday, April 23, according to a news release Medical and scientific teams at the FDA and CDC examined available data to evaluate the risk of the form of blood clot known as cerebral venous sinus thrombosis (CVST) that was seen in combination with low levels of blood platelets (thrombocytopenia).

The two agencies concluded that use of the vaccine can resume…

MedTech 100 roundup: New heights reached again

One week after recording its all-time best performance, the medtech industry once again topped itself, storming even further ahead.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has been on the rise since April began, with last week’s mark of 112.25 (April 16) representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index has already bested itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

The rapid improvement continues to shine a light on the strong position the industry has maintained more than a year on from the height of the COVID-19 pandemic’s impact on medtech. The industry has produced a 24.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets fared di…

The 10 largest orthopedic device companies in the world

[Image from Pixaby]Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

Next>>

The 10 largest orthopedic device companies in the world

[Image from Pixaby]

Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the w…

FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

J&J Vision wins regulatory nods for phacoemulsification machine

Johnson & Johnson Vision (NYSE:JNJ) announced today that it received FDA 510(k) clearance and CE mark for its Veritas vision system.

Santa Ana, Calif.–based Johnson & Johnson Vision’s next-generation Veritas phacoemulsification system is designed to allow surgeons to guide through any lens density with less surge and more stability. It also incorporates advancements in ergonomics to enhance usability during cataract surgery, according to a news release.

Veritas’ approvals in the U.S. and Europe follow recent FDA nods for J&J Vision’s Tecnis Eyhance and Tecnis Eyhance Toric II intraocular lens for treating cataract patients, the company said.

Johnson & Johnson Vision intends to begin the full commercial launch of the Veritas system around the globe later this year, the company said.

“While the phacoemulsification technique has been used successfully for decades, ease of use continues to be the unmet need wi…

Why demand for J&J and AstraZeneca COVID-19 vaccines remains unclear

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others.

The European Medicines Agency (EMA) did, however, advise that the vaccine bear a warning describing a risk of rare blood clots.

Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily.

…

PhysIQ, Janssen partner on digital therapeutics

[Image from PhysIQ]PhysIQ announced today that it is collaborating to license its AccelerateIQTM platform with Janssen Pharmaceuticals.

Chicago-based PhysIQ’s AccelerateIQTM will be licensed to Janssen, a Johnson & Johnson unit so it can deploy it to collect data across its clinical studies through a range of its wearable biosensors, while also utilizing PhysIQ’s portfolio of FDA-cleared digital biomarkers and its medical-grade platform to transform raw data into clinical insight, according to a news release.

The collaboration is set to highlight the maturation of digital medicine and the strategic clinical implications of digital therapeutics for biopharma clinical and commercial teams, the companies say.

PhysIQ noted that a massive push for decentralized trials and a regulatory focus on quality of life markers have propelled biosensor data into a new category as a “must-have” data set to evaluate the safety and efficacy of phar…

Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots.

At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that a warning for this potential issue should be added to the vaccine’s product information and the events should be listed as a very rare side effect of the vaccine, according to a news release.

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

Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots.

At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that a warning for this potential issue should be added to the vaccine’s product information and the events should be listed as a very rare side effect of the vaccine, according to a news release.

The committee considered all available evidence of the events, which came to the fore after six reports of blood clots and one death in the U.S., which led to the country pausing use of J&J’s vaccine. EMA cited eight reports from the U.S. regarding blood clots among more than 7 million people who had received the J&J vaccine.

Blood clots occurred mostly at unusu…

Johnson & Johnson rises on Street-beating Q1

Johnson & Johnson (NYSE:JNJ) are up today on first-quarter results that topped the consensus forecast, with the life sciences giant upping its 2021 earnings forecast.

The New Brunswick, N.J.–based company posted profits of $6.2 billion, or $2.32 per share, on sales of $22.3 billion for the three months ended March 31, 2021, for a 6.9 bottom-line gain on sales growth of 7.9%.

Adjusted to exclude one-time items, earnings per share were $2.59, 25¢ ahead of Wall Street, where analysts were looking for sales of $22 billion.

Johnson & Johnson said the sales growth of 8.8% in its medical device segment reflected the market recovery from the early difficulties during the COVID-19 pandemic. In comparison, its pharmaceutical business saw 7.4% growth as well.

“Johnson & Johnson delivered a strong first-quarter performance led by the above-market growth of our pharmaceutical business and continued recovery in medical devices,” J&J chair …

Fauci: J&J vaccination could resume shortly

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert.

FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination.

Fauci stressed that he was uncertain how CDC and FDA might proceed with the vaccine but believed that it was unlikely the pause would become permanent.

The vaccine will likely be accompanied by a warning mentioning a small risk of blood clotting problems, including cerebral venous sinus thrombosis presenting with low platelet count.

“I do think that there will likely be some sort of warning or restriction or risk assessment. I don’t think it’s just going to go back and say, ‘OK, everything’s fine,’ and go right back,” Fauci said in an interview with NBC’s “Meet the Press.”

A CDC advisory panel is s…