Pfizer

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…

Big Pharma behemoth Pfizer (NYSE: PFE) has dosed the first participants in a pivotal Phase 3 clinical trial to test its quadrivalent modified RNA (modRNA) influenza vaccine candidate.  The mRNA flu vaccine study will enroll roughly 25,000 healthy U.S. adults. Pfizer is not the only company to develop an mRNA flu vaccine. In December, Moderna (Nasdaq:MRNA)…

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX). The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old. Individuals in those age groups who have waited…

Pfizer (NYSE:PFE) and Morgan State University have unveiled a novel program known as the Doctor of Public Health (DrPH) Fellowship in Vaccines Medical Development. A central aim of the program is to foster diversity in vaccine development.  In particular, the two-year DrPH program aims to increase the number of minority scholar-practitioners involved in vaccine development. In addition,…

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster. Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters. Last week, the UK approved Moderna’s bivalent COVID-19 vaccine…

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates. One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant. A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led…

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.  But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.  A variety of companies are developing next-generation COVID-19 vaccines that could potentially…

Pfizer (NYSE:PFE) said it is planning on filing a supplemental Biologics License Applications (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate in infants by the end of the year. After announcing positive data from a pivotal U.S. Phase 3 study (NCT04382326), the company said the 20vPnC vaccine candidate, if approved, would offer the broadest serotype…

As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5. The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity…

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines. “We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha. While White House officials called for developing inexpensive novel vaccines that…

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time. FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the…

Pfizer Inc. (NYSE:PFE) has filed a new drug application (NDA) with the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for individuals facing a high-risk for progression to severe illness from COVID-19. Paxlovid consists of the SARS-CoV-2 main protease inhibitor nirmatrelvir (PF-07321332) and  the HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. Because…

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine.  The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the…