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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FDA approves Pfizer’s JAK1 inhibitor Cibinqo for moderate-to-severe atopic dermatitis

Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD).

In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales by 2027.

The agency also approved AbbVie’s (NYSE:ABBV) JAK inhibitor Rinvoq for patients with moderate-to-severe atopic dermatitis who are at least 12 years old.

Both approvals are limited to patients who fail to find adequate relief from other drugs or in cases when the use of other medications is inappropriate.

Last year, FDA recommended that JAK inhibitors have updated safety warnings given a potentially elevated risk of cardiovascular complications in patients taking such drugs.

FDA approved 100- and 200-mg doses of Cibinqo with a 50-mg option available for certain patients.

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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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7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

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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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Pfizer and BioNTech set their sights on developing mRNA-based shingles vaccine

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles).

Roughly one million people in the U.S. get shingles each year, according to the CDC.

Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market. Shingrix won FDA approval in 2017.

In 2020, Shingrix generated £1.99 billion ($2.55 billion) in sales internationally.

Pfizer and BioNTech began working together on an mRNA vaccine for influenza in 2018. Two years later, the two companies began work on a COVID-19 vaccine, which has since become one of the bestselling pharmaceutical products in the world.

The shingles mRNA vaccine collaboration will bring together Pfizer’s antigen technology and BioNTech’s mRNA platform.

The two companies will split development costs and plan on beginning clinical trials in th…

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Israeli researchers release data on fourth dose of COVID-19 vaccine

Photo by cottonbro from Pexels

Early data from Israel’s Sheba Medical Center showed that an additional booster of COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) led to a fivefold increase in antibodies one week after receipt of the vaccine. 

Pfizer had earlier announced that a third dose of the vaccine increased antibody levels 25-fold compared to a two-dose primary series. 

Pfizer and BioNTech, along with their competitor Moderna (NSDQ:MRNA), continue to develop an omicron-specific version of their mRNA vaccine. 

The prospect of a fourth dose of the original vaccine for immunocompetent people may be more controversial than a third. 

While Israel has begun administering a fourth dose to some individuals, the head of the French vaccination program, Dr. Alain Fischer, said there was insufficient evidence at present to recommend an additional vaccine dose. France could dec…

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Our top medtech stories of 2021

Covering the medical device industry enables writers to report on a wide range of world-changing news – financial markets, the pandemic, and the global supply chain problems – while also centering on jaw-dropping technology that improve patient care.

You’ll hear all those issues covered in our editorial’s team summation of their Top Stories of 2021 recorded in our recent episode of the DeviceTalks Weekly Podcast.

The editors of our life sciences pages picked the stories that meant most to THEM in a very transformational year.

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COVID-19 vaccine makers adjusting to omicron 

Photo from Pexels

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.  

But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron. 

In October, the Moscow-based Institute of Human Stem Cells announced its plans to test the efficacy of its Betuvax-CoV-2 vaccine against omicron and create a new version of the vaccine if needed.

Inovio (NSDQ:INO) announced in late November 2021 that it would conduct tests of its DNA vaccine candidates INO-4800 and INO-4802 against omicron and that it had begun preclinical development of an omicron-specific vaccine. 

Valneva (NSDQ:VALN) is also testing the ability of its VLA2001 to protect against omicron.  Read more

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The top 5 drug discovery stories of 2021

Image courtesy of Pixabay

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which drew revenue figures from the prior year. But in 2021, companies like Pfizer and Moderna sold tens of billions of dollars of COVID-19 vaccine alone. As a result of the ongoing pandemic, significant shifts are likely in 2022’s forthcoming ranking of pharma leaders.

Here, we provide an opportunity to review the 2021 pharma landscape, including stories that received the most attention on social media.

1. Pharma 50: The 50 largest pharmaceutical companies in the world

The top 50 largest pharmaceutical companies raked in $851 billion…

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FDA authorizes Pfizer’s Paxlovid oral COVID-19 antiviral

Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) became the first oral SARS-CoV-2 antiviral to win emergency use authorization (EUA).

The EUA covers the use of the drug to treat mild-to-moderate COVID-19 in patients who are at least 12 and weighing at least 40 kg (88 pounds).

The agency has yet to officially weigh in on molnupiravir, an oral antiviral from Merck and Ridgeback Biotherapeutics that has won approval in the U.K. In late November, an FDA advisory committee narrowly blacked that drug.

FDA’s authorization of Paxlovid requires a prescription. The agency recommends using the drug as soon as possible after a positive COVID-19 test result, specifying it should not be used five days after symptoms develop.

The authorization does not cover the use of the drug as pre-exposure or post-exposure prophylaxis.

“Today’s authorization introduces the first treatment for COVID-19 that is in the f…

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