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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.
Valneva SE and Pfizer reported positive Phase 2 results for their Lyme disease vaccine candidate, VLA15, showing a strong immunogenic response in participants aged 5-17. One month post-vaccination, pediatric participants demonstrated better immunogenicity compared to adults. The safety profile was consistent with earlier adult trials, with no serious adverse events noted. Both companies plan to include pediatric participants in the upcoming Phase 3 trial, set to begin in Q3 2022, pending regulatory approval.
Pfizer Inc. (NYSE: PFE) will hold its 2022 Annual Meeting of Shareholders virtually on April 28, 2022, starting at 9:00 a.m. EDT. Shareholders should log in at 8:45 a.m. EDT using their control numbers to participate fully. Questions can be submitted in advance until 5:00 p.m. EDT on April 26. Guests can listen without a control number. The webcast will be accessible for one year post-meeting. Shareholders can find registration details at www.meetnow.global/MWPVZT2.
Pfizer and BioNTech announced positive results from their Phase 2/3 clinical trial, showing a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers after a booster dose for children aged 5-11. The booster also resulted in a 6-fold increase against the wild-type strain. In total, the trial involved 140 children, with no new safety signals reported. The companies plan to submit data for Emergency Use Authorization (EUA) in the U.S. soon, along with submissions to other global regulatory agencies.
Pfizer Inc. (NYSE: PFE) announced the appointment of David M. Denton as the new Chief Financial Officer (CFO) and Executive Vice President effective May 2, 2022. Denton, who has over 25 years of finance experience, will succeed Frank D’Amelio, who is leaving after 15 years. Denton previously served as CFO at Lowe's and CVS Health, where he played a crucial role in CVS’s acquisition of Aetna. CEO Albert Bourla expressed confidence in Denton's abilities to strengthen Pfizer's financial management and drive future growth.
Pfizer (NYSE: PFE) has announced the acquisition of ReViral, a biopharmaceutical company focused on antiviral therapeutics for respiratory syncytial virus (RSV). The agreement, valued at up to $525 million, aims to enhance Pfizer's capabilities in addressing RSV, which affects millions and leads to approximately 160,000 deaths annually. ReViral's lead candidate, sisunatovir, shows promise in clinical trials and is expected to contribute significantly to Pfizer's pipeline. The transaction awaits regulatory approvals.
Everest Medicines announced that its licensing partner, Pfizer (NYSE: PFE), has reported positive topline results from the ELEVATE UC 52 Phase 3 study of etrasimod, a novel treatment for moderately to severely active ulcerative colitis (UC). In this 52-week trial, 433 patients showed significant improvements in clinical remission at both 12 and 52 weeks compared to placebo. Etrasimod demonstrated a favorable safety profile. Pfizer plans to file for regulatory approval later this year, supported by these positive trial results.
ViiV Healthcare has received FDA approval for Cabenuva (cabotegravir, rilpivirine), the first long-acting HIV treatment specifically for virologically suppressed adolescents. The regimen allows for treatment as infrequent as six times a year, offering a crucial alternative to daily oral therapy. This approval highlights ViiV's commitment to addressing unmet needs in adolescent HIV care. The regimen's efficacy is supported by adult data and an interim analysis of the MOCHA study. However, adverse reactions were reported in 61% of adolescent participants, with injection site pain being the most common.
The FDA has expanded the emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine, allowing a second booster dose for adults aged 50 and older who have had a first booster. This also includes individuals 12 years and older with certain immunocompromises. The additional dose is to be given at least four months after the first booster. Immunogenicity data show significant increases in antibody levels post-second booster, suggesting improved protection against COVID-19 variants, particularly for vulnerable populations. The same formulation as prior doses will be used.
Pfizer announced positive results from the ELEVATE UC 52 trial, a Phase 3 study of etrasimod for ulcerative colitis. It met co-primary endpoints of clinical remission at weeks 12 and 52, alongside achieving all key secondary endpoints. The study involved 433 patients who had previously failed other therapies. Etrasimod showed a safety profile consistent with prior studies, and further results will justify future regulatory filings. Pfizer aims to initiate these filings later this year, positioning etrasimod as a potentially groundbreaking treatment option.
ViiV Healthcare announces US FDA approval for an updated label for Cabenuva, allowing treatment initiation directly with injections, bypassing the optional oral lead-in phase. This change enhances the user experience for HIV patients, streamlining the process of starting the first and only complete long-acting HIV treatment regimen. The label update is based on clinical trial results showing comparable safety and efficacy for both initiation methods. Cabenuva is indicated for virologically suppressed adults, reinforcing ViiV's commitment to innovative HIV therapies.