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Pfizer Inc. (PFE) is a global biopharmaceutical leader driving innovations in vaccine development and therapeutic treatments. This news hub provides investors and industry professionals with timely updates on corporate developments, regulatory milestones, and market strategies.
Access official press releases, earnings reports, and analysis of Pfizer's clinical trial progress. Our curated collection covers FDA approvals, partnership announcements, and research breakthroughs across oncology, immunology, and infectious disease portfolios.
Key updates include quarterly financial results, manufacturing expansions, and strategic collaborations shaping the pharmaceutical landscape. Bookmark this page for reliable insights into one of healthcare's most influential companies, with content organized for efficient navigation across devices.
Pfizer Inc. (NYSE: PFE) announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive recommendations for abrocitinib, a JAK1 inhibitor, for treating moderate to severe atopic dermatitis in adults. Another recommendation supports the approval of XELJANZ® (tofacitinib) for adults with active ankylosing spondylitis. If approved by the European Commission, both medications could provide new treatment options for patients with limited alternatives.
Pfizer Inc. (NYSE: PFE) announced the Japanese Ministry of Health's approval of CIBINQO® (abrocitinib), a JAK1 inhibitor, for treating moderate to severe atopic dermatitis in patients aged 12 and older. CIBINQO will be available in Japan at 100mg and 200mg doses. This approval is based on data from over 1,500 patients in Phase 3 studies. Pfizer aims to ensure widespread accessibility of CIBINQO in Japan, with regulatory applications submitted globally, including the US and EU. This marks a significant step in addressing treatment gaps for atopic dermatitis.
Pfizer Inc. (NYSE:PFE) announced positive top-line results from a Phase 3 study (B7471004) of PREVNAR 20™, a 20-valent pneumococcal vaccine, in adults aged 65 and older. The study demonstrated noninferior immune responses when PREVNAR 20 was administered alongside the seasonal influenza vaccine, Fluad, compared to separate administration. The safety profiles were comparable in both scenarios. The trial, involving 1,796 participants, supports CDC guidance on coadministration, aiming to improve vaccination rates against respiratory diseases.
ViiV Healthcare presented three-year findings from the Phase III TANGO study, demonstrating that the 2-drug regimen Dovato (dolutegravir/lamivudine) is non-inferior to the three-drug TAF-based regimens for HIV-1 patients. No virologic failures occurred in the Dovato group (0% vs <1% with TAF), reinforcing its viability as a treatment option. Notably, patients on Dovato displayed better management of fasting lipids. Overall adverse event rates were similar, with Dovato showing marginally higher drug-related AEs. This study was crucial in establishing Dovato's long-term effectiveness.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted data to the U.S. FDA for their COVID-19 vaccine aimed at children aged 5 to <12 years. The Phase 2/3 trial included 2,268 participants and showed a favorable safety profile with robust neutralizing antibody responses from a 10 μg two-dose regimen. A formal request for Emergency Use Authorization (EUA) is expected in the coming weeks, with plans for submissions to other regulatory authorities, including the European Medicines Agency (EMA).
Topline results for younger cohorts (ages 2-5 and 6 months-2 years) are anticipated in Q4 2021.
ViiV Healthcare announced that the FDA has accepted and granted Priority Review for its New Drug Application (NDA) for cabotegravir long-acting, intended for HIV pre-exposure prophylaxis (PrEP). If approved by the target date of
ViiV Healthcare has announced a collaboration with Shionogi for S-365598, a third-generation HIV treatment aimed at ultra long-acting regimens. The agreement includes an upfront payment of £20 million and additional milestone payments totaling £15 million, alongside royalties on sales. Preliminary data suggest S-365598 could offer a distinct resistance profile and longer dosing intervals, enhancing patient adherence. Clinical studies are expected to start by 2023. This partnership aims to strengthen ViiV's pipeline for innovative therapies beyond 2030.
Pfizer Inc. (NYSE: PFE) has commenced a Phase 1 clinical trial for a single dose quadrivalent mRNA influenza vaccine, targeting healthy adults. This innovative vaccine utilizes mRNA technology, which offers quicker manufacturing and potentially better efficacy compared to traditional vaccines. The trial aims to assess safety, tolerability, and immunogenicity. Influenza causes about 5 million severe illness cases and up to 650,000 deaths annually, highlighting the need for more effective vaccines. Pfizer plans to expand mRNA technology beyond influenza to other respiratory viruses and oncology.
Pfizer (NYSE: PFE) has initiated the Phase 2/3 EPIC-PEP trial, evaluating the oral antiviral PF-07321332, co-administered with ritonavir, for COVID-19 prevention among adults in close contact with infected individuals. This trial aims to enroll up to 2,660 participants to assess the drug's safety and efficacy in preventing SARS-CoV-2 infection. PF-07321332 is designed for early use, potentially before hospitalization is needed. The trial is part of a broader global study aiming to tackle COVID-19's ongoing impact.
