Intuitive posts Street-beating Q4 despite COVID-19-related procedure disruptions

Intuitive (Nasdaq: ISRG) shares slid in pre-market trading today despite fourth-quarter results that topped the consensus forecast.

The Sunnyvale, California-based robotic surgery technology developer posted profits of $380.6 million, or $1.04 per share, on sales of $1.6 billion for the three months ended Dec. 31, 2021, narrowly increasing its bottom line by about $100,000 on sales growth of 10.5% year-over-year.

Adjusted to exclude one-time items, earnings per share were $1.30, 2¢ ahead of Wall Street, while sales beat analysts’ projections by approximately 0.8%.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the fourth quarter of 2020, as last year was adversely affected by the COVID-19 pandemic. Intuitive said in a news release that the resurgence of COVID-19 late in the fourth quarter of 2021 also impacted procedures, though.

Intuitive did not provide financial guidan…

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Generic manufacturers to make cheaper version of Merck’s COVID-19 pill for developing countries

Image courtesy of Merck & Co.

The Medicines Patent Pool (MPP) announced today that it signed agreements with 27 manufacturers to produce Merck’s COVID-19 pill.

MPP’s agreements with the generic manufacturing companies cover the manufacturing of the oral COVID-19 antiviral medication molnupiravir, with supply set for 105 low- and middle-income countries (LMICs). The agreements come as a result of the voluntary licensing agreement signed by MPP and MSD, a trade name of Merck, to facilitate the affordable global access of the antiviral drug that MSD is developing in partnership with Ridgeback Biotherapeutics.

Companies offered the sublicenses — which allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself — successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance and t…

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Pfizer’s Paxlovid holds up to omicron in studies

Pfizer (NYSE:PFE) revealed that its COVID-19 drug Paxlovid retained in vitro efficacy against the omicron SARS-CoV-2 variant.

The company said that the research indicates that the drug can potentially maintain plasma concentrates “many-fold” times higher than the level needed to prevent replication of the highly transmissible variant.

“These data suggest that our oral COVID-19 therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern,” said Dr. Mikael Dolsten, chief scientific officer at Pfizer, in a statement.

Demand for Paxlovid, which FDA authorized in late December, has far exceeded supply.

In January, the White House announced that the federal government would buy 20 million courses of Paxlovid — twice as much as initially planned.

Paxlovid combines two antivirals — nirmatrelvir and ritonavir.

In November 2021, Pfizer also announced a license agreement w…

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Markey wants COVID-19 test-makers to lower prices

Sen. Ed Markey, D-Massachusetts

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

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

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Democratic senator wants COVID-19 test-makers to lower prices

Sen. Ed Markey (D-Massachusetts)

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

The letters could carry some weight because Markey is not only …

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BioNTech and InstaDeep use AI to predict high-risk SARS-CoV-2 variants 

BioNTech (NSDQ:BNTX) and the enterprise AI company InstaDeep have announced that they have created an early warning system to improve the monitoring of potentially dangerous SARS-CoV-2 variants.

The companies claim that the system spotted more than 90% of WHO-designated variants an average of two months before the organization officially classified them. For example, the system classified the omicron variant as “high risk” on the same day its sequence was released.

BioNTech and InstaDeep plan on publishing the research in a peer-reviewed journal. The study is currently available as a pre-print. The paper notes that hundreds of new variants emerge daily, but most do not significantly alter the course of the pandemic.

The AI system considers the structure of the viral variants’ spike protein and their immune escape proclivity.

The two companies used in-house experimental data and public data to test the system’s accuracy.

Dr. Ugur Sahin, CEO …

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WHO concludes that updated COVID-19 vaccines may be needed

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary.

Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron variant.

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

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WHO concludes that updated COVID-19 vaccines may be needed

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary.

Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron variant.

A World Health Organization (WHO) technical advisory group concluded that current COVID-19 vaccines might require modification but acknowledged that more research is needed.

In an interim statement, the independent group also concluded that “a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

The body also urged that governments worldwide ramp up the distribution of current COVID-19 vaccines.

The WHO advisory panel also predicted there were multiple pathways for drug…

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Abbott expects COVID testing demand to remain strong

Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]Abbott (NYSE:ABT) Chair & CEO Robert B. Ford has emphasized the importance of COVID-19 testing amid the ongoing omicron variant surge.

Speaking today at the 40th Annual J.P. Morgan Healthcare Conference, Ford highlighted the role testing will play as Abbott’s BinaxNow rapid antigen test and other over-the-counter testing options remain in high demand. Such has been the need for the tests that the Biden administration has ordered for eight over-the-counter COVID-19 tests per month to be covered by insurance.

“It was clear maybe because of that full-year 2020 that people really wanted to kind of believe that the silver bullet — the vaccine — will clear it all up,” Ford said, as transcribed by SeekingAlpha. “And I think it took [the delta variant of COVID-19] for us to ultimately realize that there is no silver bullet and that you have to have vaccines, therapeutics and tes…

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Moderna and Pfizer look forward to fourth dose of COVID-19 vaccine

Photo by Artem Podrez from Pexels

As COVID-19 case counts surge worldwide, executives at Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have voiced support for additional doses of their COVID-19 vaccines.

Moderna CEO Stéphane Bancel predicted that a fourth dose would be necessary by the fall as the protection of vaccine-induced antibodies fades.

In late December, Pfizer’s chief scientific officer Dr. Mikael Dolsten said a fourth dose could be necessary in the U.S. by spring.

Pfizer executives predicted that the COVID-19 wouldn’t become endemic across the world until 2024, according to Reuters. But, that said, the emergence of variants and global vaccination could influence the trajectory of the pandemic.

Several countries are considering moving forward with providing fourth doses of COVID-19 vaccine. Israel, Canada and Chile have already begun doling out fourth doses to some individuals. In t…

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FDA postpones some inspectional activities amid omicron surge

[Photo by Fusion Medical Animation on Unsplash]

The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19.

With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, according to a news release.

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

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FDA postpones some inspectional activities amid Omicron surge

[Photo by Martin Sanchez on Unsplash]The FDA announced earlier this week that it made some temporary changes to its inspectional activities as a result of COVID-19.

With the Omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021 to ensure the safety of its employees and the firms it regulates, according to a news release.

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

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