Intuitive Surgical stock down despite Street-beating Q4

Intuitive Surgical (NSDQ:ISRG) shares took a solid hit today despite fourth-quarter results that topped the consensus forecast.

Shares of ISRG were down -5.9% at $751.89 per share in mid-afternoon trading today. They had been down -1.1% at $790 per share after hours when the results were released yesterday.

The Sunnyvale, Calif.-based robot-assisted surgery technology developer posted profits of $365.2 million, or $3.02 per share, on sales of $1.3 billion for the three months ended Dec. 31, 2020, for a 2.1% bottom-line gain on sales growth of 4% year-over-year.

Adjusted to exclude one-time items, earnings per share were $3.58, 46¢ ahead of Wall Street, where analysts were looking for sales of $1.24 billion.

Higher revenue numbers were driven by growth in procedure volumes for Intuitive’s da Vinci surgical robot, although they were somewhat offset by fewer system placements as a result of the COVID-19 pandemic, according to a news release. Read more

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Biden leaning on Defense Production Act to bolster COVID-19 vaccine supplies

[Joe Biden photo from Wikipedia]

President Joe Biden has unveiled a series of anti-COVID-19 measures in his first full day in office, including signing an executive order instructing federal agencies to use the Defense Production Act (DPA) and other tools to speed the manufacture of COVID-19 vaccines and materials.

In total, the president has signed 10 executive orders intended to curb the spread of the novel coronavirus.

According to the “National Strategy for the COVID-19 Response and Pandemic Preparedness” document, the Biden administration will use the Defense Production Act to “fill any distribution gaps, including with respect to any needed refrigeration, transportation, or storage facilities.”

Biden has also moved to create a centralized federal approach to virus testing while ramping up the U.S. government’s involvement in vaccine distribution.

“President B…

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Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

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

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Amazon offers to help Biden administration with vaccine distribution

Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution.

President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office.

The letter congratulated Biden and Vice President Kamala Harris on their inauguration and said that its more than 800,000 U.S. employees — most of whom are classified as “essential workers” amid the pandemic — should receive the approved vaccines from Pfizer/BioNTech and Moderna as soon as possible.

“The essential employees working at Amazon fulfillment centers, AWS data centers and Whole Foods Market stores across the country who cannot work from home should receive the COVID-19 vaccine at the earliest appropriate time,” Amazon CEO, Worldwide Consumer, Dave Clark wrote.

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6 questions about facial swelling and COVID-19 vaccines answered

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients. But the risk of problems is miniscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery (ABCS).

In the following interview, Dr. Hah puts the risk into perspective, explains why Botox recipients are unlikely to experience vaccine-induced facial swelling and provides a suggestion for drug developers and the CDC.

1. How would you characterize the reaction from patients concerned about Moderna’s vaccine reactivity to dermal fillers?

Dr. Wilbur Hah

Hah: Though it is a potential risk, I want to emphasi…

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Biden’s COVID-19 response will make manufacturers busy

(Image courtesy of Biden for President)

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

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

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Biden’s COVID-19 response will make manufacturers busy

[Image courtesy of Biden for President]

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

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

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How to make COVID-19 clinical trial statistics meaningful to the public

[Photo by Fusion Medical Animation on Unsplash]

COVID-19 has brought a newly heightened awareness of the need to better understand clinical trial statistics and their direct impact on the public. I cannot remember when statistical data was more in the limelight than now. The pandemic’s first wave put many countries into lockdown. All governments and their local representatives delivered press conferences regularly to update the masses on the newest statistics and safety precautions. There were statistics on how many people caught the disease, how many deaths, how many ICU beds were still available, and just about every interesting statistic you could think of related to the pandemic. 

Data collected from the COVID-19 pandemic continues to be used to inform decisions and make future projections related to drug development and beyond. Individuals are also using pandemic statistics to decide how to live th…

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New COVID-19 variants could diminish vaccine efficacy

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.  

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call. 

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

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New COVID-19 variants could diminish vaccine efficacy

COVID-19

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.  

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call. 

The Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) vaccines promise 95% efficacy at reducing symptomatic disease when it comes to the SARS-CoV-2 strains that were dominant in 2020. But it’s plausible the efficacy number could drop to 85% or beyond. “I am definitely not saying that the vaccines would be non-functional anymore or would drop to less than 50% efficacy,” Crotty said.

While Pfizer recently released data suggesting their vaccine w…

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GE Healthcare reportedly lays off 140 in Wisconsin

GE Healthcare (NYSE:GE) has reportedly laid off 140 employees at its Madison, Wis. facility due to decreased demand for certain products.

The Wisconsin State Journal reported that union representatives confirmed that layoffs came after the need for new ventilators and anesthesia machines has decreased. Demand for such devices had been high over the past year as a result of the COVID-19 pandemic.

According to the report, the company had hired about 250 employees at the Madison facility amid the increased demand for the machines as the pandemic gained steam. However, production has lessened as the need for such devices decreases.

GE Healthcare laid off about 50 employees in September before adding another 90 layoffs last Friday, the International Association of Machinists and Aerospace Workers Local 1406 told The Wisconsin State Journal.

A company spokesperson told the news outlet that GE Healthcare plans to work with employees included in the layof…

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Cybercriminals manipulated COVID-19 vaccine files before sharing them

Pfizer-BioNTech vaccine image courtesy of Wikipedia

The perpetrators of a cyberattack against the European Medicines Agency found and later released data regarding the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). 

But the cybercriminals altered the data in a manner that could undermine trust in vaccines, according to a statement from the European Medicines Agency (EMA).

The disclosed documents included internal emails from late 2020 that contained information about the regulation of COVID-19 vaccines in Europe. 

The breach also involved PowerPoint, PDF and Word documents and peer review comments from EMA. 

A post containing a link to the manipulated documents has been posted on the dark web with the title, “Astonishing fraud! Evil Pfffizer! Fake vaccines!”

Another thread posting links to the modified files stated they were evidence of a “big data scam.” 

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