Johnson & Johnson to spin off consumer segment

Recently, General Electric (NYSE:GE), Zimmer Biomet (NYSE: ZBH) and Toshiba (TYO:6502) announced their plans to slim down by spinning out core businesses. Now, Johnson & Johnson (NYSE:JNJ) is following a similar approach by making its consumer health business a standalone company.

J&J will retain its pharmaceutical and medical device segments.

The company said in an announcement that it made the decision to boost operational performance and strategic flexibility.

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

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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.

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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.

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

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9 things to know as AstraZeneca and J&J COVID-19 vaccines face safety scrutiny

[Photo by Daniel Schludi on Unsplash]With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus.

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed severe blood clot disorders.

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines. FDA anticipates that the pause in J&J vaccine use will last a matter of days.

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

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EMA begins investigation of J&J COVID-19 vaccine’s blood clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine. 

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca. 

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died. 

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Johnson & Johnson COVID-19 vaccine shipments plunge

Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000. 

The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes an Emergent BioSolutions plant in Baltimore to produce the vaccine. 

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

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Factory error ruins 15M J&J COVID-19 vaccine doses

Employees at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.

A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” according to a statement from Johnson & Johnson.

The batch did not reach the fill-and-finish stage of manufacturing.

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DTW Podcast: McEvoy gives edge to J&J’s second-mover strategy in digital surgery

Johnson & Johnson may have left the gate than some digital surgery competitors but Ashley McEvoy, executive vice president, worldwide chairman, medical devices, says the company has the technology and the team to win the race.

In an interview with DeviceTalks Weekly Podcast, McEvoy said robotic and digital surgery systems currently on the market have only been adopted by a small percentage of providers, leaving the field open for new competitors like J&J.

“Surgery is a slow adoption business,” McEvoy said,

While offering “huge respect” for the first movers. McEvoy said J&J enjoys market leadership right now in surgery. Its size and reach will open doors for its three digital surgery systems – Velys, Monarch and Ottava.

“We’re going to have a differentiated value proposition doing so in a broad-based healthcare, J&J fashion, not just like a standalone med tech company,” she said.

McEvoy pointed to the team J&J as as…

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J&J leader McEvoy lays out future for medtech giant; Stryker’s Murray talks 3Dprinting

J&J’s Ashley McEvoy talks COVID-19, Digital Surgery, Innovation and the future of Vision Care.

In this week’s DeviceTalks Weekly Podcast, the 50th of the series, Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson, makes her DeviceTalks Weekly debut.

In this update, McEvoy delivers great insights on several areas of interest including:

COVID-19’s impact on J&J in the past, and what changes may remain in the future. J&J’s far-ranging digital surgery portfolio could bolster many of its specialties. How the company uses its innovation network to accelerate development Why she’s bullish on the future of eye care. How the company will prepare for future challenges.

We also talk with Naomi Murray, Director of Advanced Operations-Additive Technology at Stryker about her almost predestined path to join the orthopedics leader.

She’ll be leading the March 23 discuss…

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DTW Podcast: Can AI, advanced imaging and robotics “democratize” surgery?

A new generation of digital surgery systems will level the playing field for surgeons giving them artificial intelligence, robotic tools and other assistive technologies.

In three interviews in this week’s DeviceTalks Weekly Podcast, leaders form Asensus, ActivSurgical and Memic explain how their systems will improve surgeon performance, reduce errors, and deliver the “democratization” of surgical robotics.

Guests this week include

Anthony Fernando, CEO of Asensus Surgical (formerly Transenterix), outlines the company’s bid to push its Sehance system as a solution for laparoscopic procedures. Fernando, who took over as CEO in 2019, explains why the company’s stock crashed in 2019 and details the changes that he says has started the company’s turnaround. Senhance offers more responsive surgical tools along with data that will help with surgical training and scheduling.

Todd Usen, CEO of ActivSurgical, left a job he loved at Olympus to lead a compan…

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Is there a link between Bell’s palsy and COVID-19 vaccines?

Image courtesy of Nataliya Vaitkevich via Pexels.

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.

Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.

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

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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.

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