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Pfizer and Moderna win FDA nod for XBB.1.5 COVID-19 vaccine boosters, but projected sales pale in comparison to 2022’s

As Pfizer and Moderna receive the FDA nod for COVID-19 boosters, their 2023 global sales projections appear to be just a fraction of the previous year’s. In 2022, Pfizer and its partner BioNTech jointly sold $56 billion worth of their Comirnaty COVID-19 vaccine, marking the best-selling drug of the year. Moderna’s Spikevax COVID-19 vaccine wasn’t far behind, registering sales of $18.4 billion, signifying the fifth best-selling drug.

After the FDA nod for COVID-19 boosters, market projections remain subdued

Demand for COVID-19 vaccines, however, appears to be relatively weak, a reality reflected in revenue guidance from Pfizer and Moderna. The former announced in its Q2 2023 revenue guidance that it projects its COVID-19 vaccine sales of approximately $13.5 billion — a 64% slide from its respective 2022 global sales of $37.8 billion. Meanwhile, Moderna expects its 2023 COVID-19 vaccine sales in the range of $6 billion to $8 billion.

A simple li…

Top 12 reported events for Moderna and Pfizer omicron-targeting COVID-19 boosters

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

With updated COVID-19 boosters set to launch in the near future and COVID-related hospitalizations on the rise again, scrutiny is on the rise of emerging variants and the benefit-safety profile of COVID-19 vaccines.

We performed a retrospective analysis of data from the Vaccine Adverse Event Reporting System (VAERS), focusing on the period covering the launch of the bivalent COVID-19 boosters in 2022 to August 25, 2023. The data captures 15,592 reported events for the Moderna vaccine and 21,553 for the vaccine from Pfizer and BioNTech.

COVID-19 reports: Correlation does not equal causation

Both Moderna and Pfizer vaccine boosters have associated reports of …

Moderna and Pfizer ready updated COVID-19 boosters to combat BA.2.86 and other emerging variants

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Against the backdrop of a nearly 16% spike in COVID-19 hospitalizations in late August, according to CDC data, federal authorities are gearing up to greenlight updated boosters. Moderna announced that its latest COVID vaccine is effective against this new strain. Meanwhile, Pfizer revealed positive preclinical data for its vaccine, developed in collaboration with BioNTech.

In late August, Novavax also announced that its updated protein-based XBB COVID vaccine candidate retained neutralizing antibody responses to several emerging subvariants, including EG.5.1 and XBB.1.16.6. Unlike the mRNA-based boosters from Pfizer and Moderna, Novavax’s COVID vaccine would be the sole protein-based non-mRNA vaccine option available for the upcoming fall season.

The following visualization, based on CDC data, highlights the top SARS-CoV-2 variants for August and Sept…

Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine

Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now highlights as the first FDA-approved maternal vaccine to guard infants against RSV.

In early May, GSK’s Arexvy became the first to win FDA’s blessing to protect individuals aged 60 and above from RSV complications. By the end of the month, Pfizer had won approval for Abrysvo in the same age group.

Yet, behind the scenes of these approvals, legal clouds gather. GSK has taken its grievances to a federal court in Delaware, alleging that Pfizer infringed on four of its patents related to its Arexvy vaccine. In a Reuters-posted filing, GSK claims it began work on its RSVPreF antigen in the early 2000s. In th…

Pfizer and Moderna tout preliminary data in battle against Eris SARS-CoV-2 subvariant

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COVID-19 vaccine giants Pfizer and Moderna are gearing up for a battle against the Eris SARS-CoV-2 subvariant, which has rapidly emerged as the dominant strain in the U.S. Eris now is responsible for more than one in five COVID infections, based on CDC estimates from August 6 to 19.

Pfizer has noted that its most recent COVID-19 shot, which it is testing against emerging variants, demonstrated neutralizing activity against the “Eris”in a mouse study. The company said it is keeping a close watch on the variant and is ready to produce “variant-modified vaccine templates” if needed. Pfizer intends to launch its updated vaccine commercially by the end of August, pending regulatory approval.

Moderna has also announced positive preliminary testing of its latest vaccine shot against the Eris SARS-CoV-2 subvariant. The company indicates that preliminary clinical trial data demonstra…

How COVID vaccine options stack up for fall 2023

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The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. The advisory committee has set its sights on protecting against XBB.1.5 and has jettisoned is support for vaccines with a Wuhan component, which was included as a component of the bivalent vaccine boosters that debuted in fall 2022. “Continuing to include the original Wuhan strain was unnecessary since early strains are no longer in circulation,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases.

While supporting monovalent vaccines, VRBPAC members acknowledged that the predominant SARS-CoV-2 sublineages could continue to evolve. “We may well find that XBB.1.16 or XBB.2.3 become more dominant than XBB.1…

Pfizer drops one weight loss drug, bets on another

Pfizer has made a strategic decision in the battle against obesity and diabetes. The pharmaceutical giant has chosen to discontinue its GLP-1 RA candidate, lotiglipron, to focus resources on the development of another – danuglipron. This Pfizer weight loss drug is now the lead candidate in late-stage trials for the treatment of obesity and diabetes. The decision comes after the discovery of elevated liver enzyme levels in some early trial patients for lotiglipron. However, similar concerns have not arisen with danuglipron.

The shift comes as the company aims to tap full receptor agonism for potential robust efficacy, capitalizing on its small molecule design expertise. With more than 1,400 patients already enrolled, the clinical trial results could potentially expand the treatment options for adults with obesity and Type 2 diabetes.

Already, GLP drugs semaglutide and tirzapatide are beginning to reshape the way we treat obesity.

Novo Nordisk’s sema…

An overview of the RSV vaccine landscape: What comes after GSK’s approval of Arexvy?

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GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations.

The GSK vaccine targets adults aged 60 and older. In clinical studies, the single-dose vaccine demonstrated strong efficacy in preventing lower-respiratory tract infections and more severe diseases. In a phase 3 study published in NEJM with a median follow-up of 6.7 months, the vaccine efficacy against RT-PCR-confirmed RSV-related lower respiratory tract disease was 82.6%.

Efficacy against severe RSV-related lower respiratory tract disease was higher at 94.1% while efficacy against RSV-related acute respiratory infection was 71.7%. The most commonly reported side effects of Arexv…

10 pioneering companies implementing AI in drug discovery, development and beyond

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The pharma industry is embracing artificial intelligence (AI) to streamline drug discovery and development, although adoption remains early. The field, however, is rapidly expanding. The global AI in drug discovery market was worth about $1.1 billion last year but could grow at a 30% clip from 2023 to 2030, according to Grand View Research.

In the years to come, AI could find use to discover an array of drug targets while improving drug developers’ ability to design molecules based on fine-grained criteria. Here, we spotlight several companies exploring the use of AI in drug discovery and drug development.

1. Exscientia

Oxford, UK–based Exscientia (Nasdaq: EXAI) has pioneered AI in small-molecule drug design. The company has expanded its AI-based platform to develop novel therapeutic antibodies through generative AI design. In early 2020, the company reported the first AI-d…

The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

An overview of the RSV vaccine candidate landscape in early 2023

[RSV image from NIAID]

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk.

Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956. A year later, the pediatrician and virologist Robert M. Chanock linked RSV to respiratory infections in children. Attempts to develop a vaccine for the virus soon followed.

Despite numerous attempts beginning in the 1960s, an FDA-approved RSV vaccine has remained elusive until recently. Out front is GSK’s (NYSE:GSK) RSV vaccine for adults aged 60 and older, which has won the backing of an FDA advisory panel. Close behind is Pfizer’s (NYSE:PFE) single-dose vaccine for the same a…

The next wave: 10 promising investigational antihypertensive drugs to watch

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Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. This review highlights ten promising antihypertensive drug candidates with the potential to address pulmonary arterial hypertension (PAH), resistant hypertension and uncontrolled hypertension.

Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin receptor antagonist (ERA), it effectively blocks the binding of ET-1 to both ET A and ET B receptors. The drug has a low likelihood of interacting with other medications and its mechanism of action is well-suited for treating resistant hypertension. In clinical trials, aprocitentan demonstrated better blood pressure reduction than placebo, with the effects lasting up to week 40, and was generally well-tolerated by patients. (Text continues beneath th…