Welcome to our dedicated page for Pfizer news (Ticker: PFE), a resource for investors and traders seeking the latest updates and insights on Pfizer stock.
Pfizer Inc. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
Pfizer announced the European Medicines Agency's acceptance of its Marketing Authorization Application for the 20-valent pneumococcal conjugate vaccine (20vPnC) targeting invasive disease and pneumonia in adults 18 and older. The review process by the Committee for Medicinal Products for Human Use begins, based on clinical data from over 6,000 participants in multiple trials. The 20vPnC vaccine addresses significant pneumococcal disease serotypes not included in existing vaccines, demonstrating Pfizer's ongoing commitment to vaccine innovation.
Pfizer (NYSE: PFE) and OPKO Health (NASDAQ: OPK) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application for somatrogon, a long-acting growth hormone for treating pediatric patients with growth hormone deficiency (GHD). If approved, somatrogon will allow once-weekly administration, reducing daily injection burdens. Results from a global Phase 3 trial showed somatrogon met its primary endpoint of height velocity non-inferiority compared to daily somatropin. A European Commission decision is anticipated in 2022.
Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) are evaluating a third dose of their COVID-19 vaccine, BNT162b2, to assess safety and immunity against circulating and emerging SARS-CoV-2 variants. This study will involve participants from a previous Phase 1 trial, who will receive the booster 6 to 12 months post-initial vaccination. Additionally, the companies are in talks with the FDA and EMA for a clinical study on a variant-specific vaccine. The goal is to ensure preparedness against future variants while maintaining current vaccine effectiveness.
Seven Bridges is partnering with Pfizer (NYSE: PFE) to enhance the management of single-cell RNA sequencing (scRNASeq) data. This collaboration aims to optimize Pfizer's cloud capabilities and data analysis through the cloud-based Seven Bridges Platform, which will handle terabytes of scRNASeq data and improve the understanding of gene expression. The initiative is expected to streamline data accessibility and reduce costs associated with sequencing data, bolstering Pfizer's research and development efforts in drug discovery.
Pfizer Inc. (NYSE:PFE) announced that the FDA accepted its Biologics License Application (BLA) for TicoVac™, a tick-borne encephalitis (TBE) vaccine aimed at individuals aged 1 and older. If approved, TicoVac would become the first TBE vaccine in the U.S. with a decision expected by August 2021. The vaccine has a strong efficacy rate of 96-99% following two doses and has been used globally for over 40 years. This acceptance reflects the FDA's acknowledgment of its potential in preventing TBE in endemic areas.
Pfizer (NYSE: PFE) announces a webcast featuring Angela Hwang, Group President of Pfizer Biopharmaceuticals Group, at the Cowen 41st Annual Health Care Conference on March 1, 2021, at 3:20 PM EST. The webcast aims to engage investors and the public in discussions about Pfizer's initiatives and performance metrics. Interested participants can listen to the live event or access an archived copy on www.pfizer.com/investors. This communication reflects Pfizer’s commitment to transparency and investor engagement.
Pfizer (NYSE:PFE) has initiated the Phase 2 MagnetisMM-3 study of elranatamab, a novel bispecific antibody targeting B-cell maturation antigen in patients with relapsed/refractory multiple myeloma. The trial aims to assess the efficacy and safety of the drug, with an estimated primary completion date of June 2022. Elranatamab has received Fast Track Designation from the FDA, which accelerates its development process. Early Phase 1 results indicate promising response rates, with 83% of patients responding at the highest dose. This development is crucial for multiple myeloma treatment.
Pfizer (NYSE: PFE) and BioNTech have secured an agreement with the European Commission to supply an additional 200 million doses of their COVID-19 vaccine, COMIRNATY®. This agreement complements a previous commitment of 300 million doses for 2021. The total expected supply could reach 600 million doses by year-end, with 75 million anticipated in Q2. Pfizer aims to vaccinate at least 250 million Europeans by the end of 2021. Both companies are ramping up production capabilities to meet rising global demand for vaccines.
Pfizer Inc. (NYSE: PFE) has received FDA approval for its supplemental Biologics License Application for PANZYGA®, an intravenous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This approval introduces additional maintenance dosing options, enhancing treatment customization for patients. The approval follows positive results from a Phase 3 study involving 142 patients, showing an 80% response rate with the 1.0 g/kg dose. PANZYGA is also noted for its favorable safety profile, with common side effects including headache and fever.
Pfizer (NYSE: PFE) announced a U.S. Patent Term Extension (PTE) for IBRANCE® (palbociclib), extending U.S. Patent No. RE47,739 until March 5, 2027. The extension, granted under the Drug Price Competition and Patent Term Restoration Act of 1984, will be listed in the FDA's Orange Book. IBRANCE is an oral CDK 4/6 inhibitor used for treating HR+, HER2- advanced or metastatic breast cancer, approved in over 100 countries and prescribed to more than 350,000 patients worldwide.