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Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer

Sanofi (NYSE:SNY) announced today that it entered into an agreement to support the manufacturing and supply of the Pfizer/BioNTech COVID-19 vaccine.

Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020.

The deal between Sanofi provides BioNTech access to its infrastructure and expertise to produce over 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt starting in the summer of 2021, according to a news release.

“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. Today’s announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic,” Sanofi CEO Paul Hudson said in the release. “Although vaccination campaigns have started a…

Johnson & Johnson gearing up for COVID-19 vaccine data announcement

Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week.

In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details.

“We think it’s very important to follow the data — to follow the science,” said JNJ CEO Alex Gorsky after declining to answer a question related to COVID-19 variants and vaccine efficacy until the official data announcement.

[Related: Johnson & Johnson pharma sales drive Street-beating Q4 results]

If the company’s adenovirus-based vaccine performs in the same league as those from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE), Ad26 could play a vital role in stemming the COVID-19 crisis. Unlike competitors’ vaccines, Ad26 could be offered in a single dose, potentially simplifying mass-vaccination efforts.

Former Operation Warp Speed chief Moncef Slaoui suggested that Ad26 vaccine…

Diagnostics sales boost Abbott in Street-beating Q4

Abbott (NYSE:ABT) shares ticked up this morning on fourth-quarter results that bested the consensus forecast.

The Abbott Park, Ill.-based company posted profits of $2.2 billion, or $1.20 per share, on sales of $10.7 billion for the three months ended Dec. 31, 2020, for a more than doubled bottom line on sales growth of 28.7%.

Adjusted to exclude one-time items, earnings per share were $1.45, 10¢ ahead of Wall Street, where analysts were looking for sales of $9.94 billion.

Three of Abbott’s four major businesses (nutrition, diagnostics and medical devices) saw growth in the quarter, while the company’s established pharmaceuticals arm dipped by -2.3%.

Diagnostics, in particular, saw a large leap year-over-year, with COVID-19 testing boosting the segment to more than $4.3 billion in sales, marking 111.1% growth from 2019. The medical devices segment fared well, bringing in $3.3 billion for 1.7% growth, although U.S. sales dipped by -2.5%.…

Novartis shares dip after announcing disappointing Q4 results

Novartis (NYSE:NVS) posted fourth-quarter results today that trailed the consensus forecast.

The Basel, Switzerland–based company reported a $2.1 billion net income, an 86% increase in Q4 2019. Earnings per share for the quarter ended Dec. 31 were $1.34 per share on revenue of $12.8 billion.

Analysts had anticipated earnings of $1.36 per share.

Still, there is room for optimism.

In an earnings call, Novartis CEO Vasant Narasimhan said the company had achieved “solid operational performance over the past three years,” after revamping its strategy in 2018. Net sales from 2017 to 2020 have grown 5% annually while its Innovative Medicines division achieved a 35% growth rate in 2020.

“We have a leading pipeline across 10 therapeutic areas [and], four advanced therapy platforms,” Narasimhan added.

Novartis has enacted a series of cost-savings measures that has enabled the company to save $2 billion in cost over the past three years. T…

BD touts study of antigen test over molecular test for identifying infectious people

Becton Dickinson (NYSE:BDX) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2.

The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth in the cell culture test indicates the presence of live virus in the patient sample, which may indicate the presence of infectious virus at the time the sample was taken. If no growth is present in the viral cell culture test, it is likely that there wasn’t enough viable virus for the patient to be contagious at the time the sample was taken, according to BD. The study was published in Clinical Infectious Diseases.

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

White House could promise states additional COVID-19 vaccines doses next week

Image from René DeAnda on Unsplash

Federal shipments of COVID-19 vaccines could increase roughly 16% next week, potentially reducing some states’ shortfalls as they have broadened access to adults 65 and older.

The U.S. government plans to increase its weekly allocation to states from 8.6 million doses to approximately 10 million doses, according to The Washington Post.

Government authorities ship COVID-19 vaccine doses to 64 jurisdictions spread across the country and eight U.S. territories.

Moderna (NSDQ:MRNA) is likely to provide the supply boost.

Pfizer (NYSE:PFE) has decided to send the U.S. fewer doses of its vaccine jointly developed with BioNTech (NSDQ:BNTX) after the surprise discovery that its vials contained an extra dose. It negotiated with the U.S. government to count the extra sixth dose in its vials toward its prior commitment to provide 200 million doses.

Bot…

GE ticks up on mixed-bag Q4

General Electric (NYSE:GE) shares ticked up today on fourth-quarter results that were mixed compared the consensus forecast.

The Boston-based company posted profits of $2.6 billion, or 27¢ per share, on sales of $21.9 billion for the three months ended Dec. 31, 2020, more than tripling its bottom line despite a sales decline of -16.4%.

Adjusted to exclude one-time items, earnings per share were 8¢, 1¢ behind Wall Street, where analysts were looking for sales of $21.8 billion.

GE Healthcare brought in nearly $5 million in revenues, marking a -15% decline attributed largely to the sale of its biopharma arm to Danaher in the spring of 2020. The segment’s profits of $949 million were down -17% from $1.1 billion last year.

The company said in a news release that its revenues were up 6% organically thanks to growth in its life care solutions business with the delivery of Carescape R860 ventilators during the COVID-19 pandemic, as well as imaging a…

Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351.

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

Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351.

The so-called “Brazil variant,” also known as P.1, possesses about 20 mutations. Like the U.K. and South African variants, researchers believe the Brazilian variant to be more transmissible, but it may also be more likely to reinfect people.

“We have followed SARS-CoV-2 mutations since January 2020,” said Moderna CEO Stéphane Bancel in the briefing. The virus has mutated many times, and it…

Abbott Panbio rapid antigen test wins CE mark for asymptomatic screening

Abbott (NYSE:ABT) announced today that it received CE Mark for two new uses of its Panbio COVID-19 Ag rapid diagnostic.

Panbio COVID-19 Ag has received an updated label with clinical data on asymptomatic individuals to enable mass testing of people who do not currently present symptoms of the disease, according to a news release.

The other update allows for self-collection of nasal specimens under the supervision of a healthcare worker, offering improved patient comfort and reduced risk of accidental exposure to the virus for healthcare workers as they can maintain their distance during testing.

Abbott Park, Ill.-based Abbott has shipped 200 million Panbio rapid antigen tests across 120 countries in Europe, the Americas, Asia and Africa since August 2020. The company has coordinated with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation to make the tests available to low- and middle-income countries.

Panbio…

Tevogen Bio’s investigational t-cell therapy for COVID-19 wins funding

In July 2020, the clinical-stage biotech Tevogen Bio (Metuchen, N.J.) announced its plans to use its proprietary T-cell therapy to treat COVID-19.

Now, the company has announced that it has received funding from HMP Partners, a team of physician-investors, to advance what it terms an “investigational curative” therapy.

Tevogen will use the funding to support clinical trials for the therapy.

The company filed an investigational new drug application with the FDA in October 2020.

The company’s TVGN-489 therapy consists of allogenic lab-grown virus-specific T cells that it hopes will recognize and destroy COVID-19-infected calls.

HMP Partners believes the therapy could be effective against COVID-19 variants. “We believe it’s imperative to create a curative treatment that is not expected to be compromised by mutations,” said HMP CEO Dr. Manmohan Patel in a statement. “Unmodified virus-specific T-cells are well established as being effective and …

Authorities investigating death of California recipient of COVID-19 vaccine

[Photo by Daniel Schludi on Unsplash]

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses.

Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward.

Placer County officials stressed they had not linked the death to the vaccine.

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