Noticias y vídeos - PFIZER INC. - Página 2

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety. The vaccine candidate is currently under FDA review for the prevention of medically...

Pfizer Inc. (NYSE:PFE) (“Pfizer”) today announced the pricing of a debt offering consisting of eight tranches of notes (collectively, the “Notes”): $3,000,000,000 aggregate principal amount of 4.650% Notes due 2025 $3,000,000,000 aggregate principal amount of 4.450% Notes due 2026 $4,000,000,000 aggregate principal amount of 4.450% Notes due 2028 $3,000,000,000 aggregate principal amount of 4.650% Notes due 2030 $5,000,000,000 aggregate principal amount of 4.750% Notes due 2033...

Pfizer Inc. (NYSE: PFE) (“Pfizer”) today announced that its wholly owned subsidiary, Pfizer Investment Enterprises Pte. Ltd. (the “Issuer”), has commenced a multi-series offering of senior unsecured notes (the “Notes”). The maturity dates of the Notes are expected to range from two to 40 years. The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Pfizer. Pfizer intends to use the net proceeds of the offering as part of the financing for Pfizer’s...

Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance. The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com . EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “This is an exciting time for Pfizer as we are already executing on and rigorously planning...

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes...

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company’s common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that...

Pfizer Inc. (NYSE: PFE) announced today that its shareholders and the general public are invited to access its virtual-only 2023 Annual Meeting of Shareholders at 9:00 a.m. EDT on Thursday, April 27, 2023. Pfizer has designed the virtual Annual Meeting to ensure that its shareholders who attend the virtual-only Annual Meeting will be afforded comparable rights and opportunities to participate as they would at an in-person meeting. Beginning today, shareholders can find additional information on...

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., BRAFTOVI + MEKTOVI is...

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, May 2, 2023. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2023 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information on accessing and...

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. The AMDAC's vote, while not binding, will be considered by the FDA when making its decision regarding the...

Pfizer Inc. (NYSE: PFE) and Seagen Inc. (Nasdaq: SGEN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion. The Boards of Directors of both companies have unanimously approved the transaction. This press release features multimedia. View the full...

Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also...

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness. The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease...

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceutical Business; Rodrigo Puga, U.S. Commercial and Global Business Lead for Internal Medicine; and Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, at the Cowen 43 rd Annual Health Care Conference on Tuesday, March 7, 2023 at 10:30 a.m. Eastern Standard...

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Priority Review is intended to direct attention and resources from regulatory authorities toward drugs that, if approved, could offer...

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. This decision follows the FDA’s Breakthrough Therapy...

Pfizer (NYSE: PFE) announced today positive results from the Phase 3 TALAPRO-2 study of TALZENNA ® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI ® (enzalutamide), demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR)...

Pfizer Inc. (NYSE: PFE) today announced publication of results in The Lancet Neurology from the Phase 3 pivotal clinical trial of zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. The study met its co-primary endpoints, showing that a single 10 mg dose of zavegepant was more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two hours post-dose. Additionally,...

Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for CIBINQO ® (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. CIBINQO was previously approved only for...

Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to a webcast of a discussion with Andy Schmeltz, SVP Commercial Strategy & Innovation, and Navin Katyal, U.S. Commercial & Global Business Lead for mRNA Portfolio at the SVB Securities Global Biopharma Conference on Thursday, February 16, 2023 at 10:00 a.m. Eastern Standard Time. To listen to the webcast, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be...