In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…

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…

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…

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…

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…

In the throes of the COVID-19 pandemic, when the world was desperate for a lifeline, the global pharma sector’s R&D prowess was thrust into the limelight. Now, as the pandemic begins to loosen its grip, the sector continues to make aggressive investments in research and development (R&D). At the tip of the spear of this…

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 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…

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.…

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…

COVID-19 vaccine developers Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have won emergency use authorization (EUA) for a single booster dose of their omicron BA.4/BA.5-adapted bivalent COVID-19 booster for kids between 6 months and 4 years of age. The booster can be administered at least two months after completing the primary vaccination series with three…

Emory University has partnered with Pfizer (NYSE:PFE) to create new drugs and therapies aimed at stopping serious disease from COVID-19. The Emory and Pfizer collaboration will take place in Emory University’s Schinazi Laboratory, led by scientist Raymond Schinazi, with the goal of producing novel antiviral compounds to combat COVID, according to The Atlanta Journal-Constitution. Although…

After a relatively quiet 2022, 2023 is anticipated to be a more robust year for pharma M&A activity. In recent months, players such as Pfizer (NYSE:PFE), Sanofi (NYSE:SNY), Chiesi, AstraZeneca (LON:AZN) and Amgen (Nasdaq:AMGN) have unveiled acquisition plans that could reshape the landscape of the sector. This article delves into the details of prominent recent…

The cell and gene therapy sector is poised to deliver a wave of new therapies with the potential to cure rare and common diseases. As many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023. While manufacturing and regulatory challenges remain,…

Pfizer (NYSE:PFE) has announced that the FDA has approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) for moderate-to-severe atopic dermatitis. The approval expands the indication for the drug, which was previously only approved for adults with the skin condition in early 2022. The expanded indication includes adolescents between the ages of 12 and…

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…

The investigational bispecfic antibody elranatamab has won breakthrough therapy designation from the FDA for relapsed or refractory multiple myeloma (RRMM). Also known as PF-06863135, erlanatamab is a B-cell maturation antigen (BCMA)-targeted T-cell redirecting immunotherapy. BCMA is highly expressed on the surface of multiple myeloma (MM) cells. Elranatamab is also designed to target the CD3 receptor…

Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate. The MATISSE (Maternal Immunization Study for Safety and Efficacy) study investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease…

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old. FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.…

The computational disease model developer CytoReason has announced that it has entered into a multi-year partnership with Pfizer (NYSE:PFE) that is potentially worth $110 million over the next five years.  In the recent partnership, Pfizer will make a $20 million equity investment in CytoReason. The company will also obtain options to license platform and disease models from…