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Pfizer’s Novel Prediction Model, Derived from Machine Learning, Shows Robust Performance for Identifying Heart Failure Patients At-Risk for Wild-Type Transthyretin Amyloid Cardiomyopathy, a Rare and Life-Threatening Condition

— Data published in Nature Communications reveals 87% accuracy in predicting wild-type transthyretin amyloid cardiomyopathy (wtATTR-CM) heart failure (HF) patients compared to non-amyloid HF patients

— This algorithm, built to help identify patients at-risk for wtATTR-CM, is the first to leverage artificial intelligence (AI)/machine learning across medical claims data

XELJANZ® Safety Review Recommendation Issued in the European Union

New York, June 11, 2021 — Pfizer Inc. (NYSE: PFE) announced today that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that XELJANZ® (tofacitinib) should only be used in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular (CV) risk factors, and patients with other malignancy risk factors, if no suitable treatment alternative is available.

Newly Published Expert Opinion Article Details Evidence for Classifying Aging Immune System as a High-Risk Condition for Pneumococcal Vaccine Policy

  • Review of scientific literature highlights increased risk of vaccine-preventable infectious diseases caused by the normal aging process that weakens immune responses
  • Increased risk associated found to be independent of other underlying medical conditions
  • Expert authors note there is enough evidence to support reevaluating adult vaccine policies to recognize the deleterious effects of immunosenesence

NEW YORK, July 8, 2021 — Pfizer Inc.

U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine

NEW YORK AND MAINZ, GERMANY, JULY 16, 2021—Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

Pfizer Issues A Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (varenicline) Tablets Due to N-Nitroso Varenicline Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., July 16, 2021.

Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Pfizer and BioNTech Share Detailed Update to the Results from 6 Month Safety and Efficacy Data Analysis of Landmark COVID-19 Vaccine Study

NEW YORK AND MAINZ, GERMANY, JULY 28, 2021—Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared the detailed six-month follow-up results from the Landmark Phase 3 study of the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) on the preprint server medRxiv and have submitted the manuscript to a peer-reviewed publication.

Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N-Nitroso Varenicline Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., August 13, 2021.

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

First Participant Dosed in Phase 2/3 Study of Oral Antiviral Candidate in Non-Hospitalized Adults with COVID-19 Who Are at Low Risk of Severe Illness

New York, N.Y., September 1, 2021Pfizer Inc. (NYSE:PFE) today shared that the first participant has been dosed in a pivotal Phase 2/3 clinical trial to evaluate the safety and efficacy of PF-07321332 – an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 – in non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection and are not at increased risk of progressing to severe illness, which may lea

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