Abstract The vast majority of vaccines are prophylactic in nature. As a result, the demonstration of their efficacy paradoxically requires the infectious disease to occur among non-diseased study participants randomized between investigational vaccine and appropriate control groups. The statistics of vaccine efficacy (VE) calculation are nearly entirely and solely based on the number of observed…

Traditionally, the tech and biotech sectors in the U.S. have been concentrated in a handful of regions — most notably in areas such as Boston, Seattle, Silicon Valley and Southern California. But the Biden administration aims to distribute innovation more evenly through the U.S. To that end, the administration has designated 31 tech hubs across…

GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…

Kathy Fernando, the senior vice president, head of Pfizer Ignite and Pfizer CentreOne, has had a professional trajectory marked by pivotal serendipities. One occurred when attending a seminar at the University of Pennsylvania, where she met Dr. Drew Weissman, a prominent immunologist and RNA vaccine researcher. Weissman, along with Katalin Karikó, recently received the Nobel…

Note: This feature on the best-selling pharmaceuticals of 2023 will be updated regularly as new data becomes available. Stay tuned for our ongoing coverage of the pharma sector’s sales dynamics. In 2023, as the grip of the COVID-19 pandemic began to loosen, the pharma sector returned to relying on immunology and oncology as sales drivers.…

 Data sourced from Our World in Data Cardiovascular disease and cancer remain the leading causes of death in the world, based on an analysis of data sources ranging from World Health Organization and Our World in Data. While respiratory illnesses were the third most common cause of death in 2019, deaths in this category…

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But with demand for COVID-19 vaccines cooling, drug developers are aiming to extend the dominion of mRNA technology…

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…

When Keri Yale, the company’s head of patient affairs and engagement at Boehringer Ingelheim (BI), joined more than 25 years ago, she recognized a need to put patients at the center of the pharmaceutical industry. Since then, she has spearheaded a transformation towards greater patient centricity at the company that started with HIV/AIDS community engagement…

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…

[Updated September 7. Article originally posted on July 21, 2023. Updates follow in bold:] 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. More recently, the emergence of new variants such…

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…

To date, there have been more than 770 million confirmed COVID-19 cases and nearly 7 million deaths from the virus, according to the World Health Organization (WHO). Vaccines remain one of the most potent tools in blunting the severity of SARS-CoV-2 infection, and vaccine developers have distributed more than 13.5 billion vaccine doses to date.…

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…

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…

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share. Adapting to COVID-19 variants The company hopes that its development of vaccines…

From tackling the COVID-19 pandemic to paving the way for future global health challenges, RNA vaccines have rapidly gained attention in recent years. Researchers are already working to extend their capabilities for next-gen medicines. For example, scientists are working to create multivalent RNA formulations that can fight multiple virus variants. They are also exploring AI…

In 2020, researchers witnessed the emergence of post-acute sequelae of SARS-CoV-2 (PASC) — more commonly referred to as “long COVID.” Now, the notion of “long vax,” persistent and varying symptoms following COVID-19 vaccination, has come into focus, as Science has noted. This phenomenon, while not as widespread as long COVID, has concerned some in the…

Oncolytic adenoviruses have won significant attention in recent years as a novel approach to cancer treatment. One example of the trend is AdAPT-001 TGF-ß Trap, an engineered variant of the common cold virus equipped with a transforming growth factor-beta (TGF-β) “trap.” This mechanism is designed to latch onto and neutralize TGF-β, an immunosuppressive cytokine involved…

In the quest to outsmart viral foes such as SARS-CoV-2, RSV and influenza, Codagenix, a clinical-stage biotech firm based in Farmingdale, New York, has engaged a unique arsenal: the intersection of synthetic biology and machine learning. Their weapon of choice is a blend of live-attenuated virus design and codon deoptimization technology. Their process involves introducing…

As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape. In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant…

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…

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10. The EUA represents a significant advance for the Jena, Germany–based company, which on March 31,…

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.…

Engineers at MIT designed a new way to trigger cells that could lead to targeted therapies for cancer and other diseases. Using an RNA sensor for the trigger, the researchers ensure that synthetic genes activate only in specific cells. They demonstrated that the sensor could accurately identify cells expressing a mutated version of the p53…