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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 (NYSE: PFE) announced FDA approval for XELJANZ® (tofacitinib) to treat adults with active ankylosing spondylitis (AS) who have inadequate response or intolerance to TNF blockers. This approval is based on a Phase 3 study involving 269 patients, where tofacitinib showed significant efficacy over placebo (ASAS20 response: 56.4% vs. 29.4%, p<0.0001). XELJANZ is notable as the first oral JAK inhibitor approved for five immuno-inflammatory indications in the U.S., providing a non-injection treatment option for AS, a condition affecting over 350,000 Americans.
Pfizer (NYSE: PFE) announced final results from its Phase 2/3 EPIC-HR study, confirming PAXLOVID's effectiveness in reducing hospitalization or death risk by 89% when administered within three days of COVID-19 symptom onset. The data will support ongoing FDA Emergency Use Authorization applications. In a secondary endpoint, PAXLOVID also reduced the risk by 88% when given within five days. Furthermore, the EPIC-SR study showed a 70% reduction in hospitalization among standard-risk adults, although it did not meet its primary endpoint for symptom alleviation. Both trials indicate significant antiviral activity against SARS-CoV-2 variants.
Pfizer has proposed to acquire Arena Pharmaceuticals for
Pfizer (NYSE: PFE) and Sangamo Therapeutics (NASDAQ: SGMO) have released updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, a gene therapy for severe hemophilia A. At 104 weeks, patients in the highest dose cohort exhibited a mean factor VIII activity of 25.4% with no annualized bleeding in the first year post-infusion. However, the Phase 3 AFFINE trial has encountered a clinical hold by the FDA following observations of elevated FVIII levels in treated patients. The ongoing studies aim to evaluate long-term efficacy and safety of this investigational therapy.
Pfizer Inc. (NYSE: PFE) has announced a quarterly cash dividend increase to
Pfizer Inc. (NYSE: PFE) announced that the European Commission approved its oral medication Cibinqo® (abrocitinib) for treating moderate-to-severe atopic dermatitis in adults. Cibinqo, a Janus kinase 1 inhibitor, is available in 100 mg and 200 mg doses, with a 50 mg dose for patients with renal impairment. The approval is backed by five clinical studies with over 2,800 patients, showing significant symptom improvement versus placebo and a favorable safety profile. This marks a vital treatment innovation for patients suffering from this chronic condition.
The U.S. FDA has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine booster, now available for individuals aged 16 and older. Administered at least six months post-primary series, the booster has shown a 95% efficacy in combating symptomatic COVID-19 compared to non-booster recipients. Pfizer and BioNTech plan to submit a supplemental Biologics License Application to formalize this authorization. The companies will continue supplying vaccines under existing agreements with the U.S. government through April 2022.
Pfizer and BioNTech announced that three doses of their COVID-19 vaccine effectively neutralize the Omicron variant, while two doses show significantly reduced effectiveness. A booster dose increases neutralizing antibody titers by 25-fold against Omicron, similar to the response against the wild-type virus. Despite two doses providing some protection against severe disease, a third dose is recommended for optimal protection. The companies are developing a variant-specific vaccine for Omicron, expected by March 2022, without impacting their production capacity of four billion doses in 2022.
Pfizer Inc. (NYSE: PFE) will hold a live webcast on December 17, 2021, at 8:30 a.m. EST, featuring discussions about the Pfizer-BioNTech COVID-19 vaccine and an oral antiviral treatment candidate. Interested parties can access the webcast via www.pfizer.com/investors. A Q&A session will follow the presentations, with pre-registration advised. The webcast replay will be available for at least 90 days. Pfizer continues to emphasize its commitment to improving healthcare and addressing COVID-19 challenges.
ViiV Healthcare has released survey data for World AIDS Day, revealing significant stigma and misinformation about HIV. Conducted by The Harris Poll among 5,047 adults in the U.S., UK, Australia, and Portugal, the survey found that 88% of respondents perceive ongoing negative attitudes towards individuals living with HIV. It also highlighted that 76% were unaware that effective treatment can prevent HIV transmission. ViiV emphasizes the need for ongoing anti-stigma campaigns, showcasing collaborative efforts like HIV in View.