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Recent Pfizer Press Releases

5/24/19 4:00pm EDT
Pfizer Announces Top-Line Results from Phase 3 Trial of LYRICA® (pregabalin) in Primary Generalized Tonic-Clonic Seizures

Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo. Lyrica is not indicated in any population for the treatment of PGTC seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).

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5/15/19 5:01pm EDT
Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting

Data spans 10 therapies across 10 types of cancer

Pfizer Inc. (NYSE:PFE) will present data across its industry-leading oncology portfolio, covering multiple tumor types and mechanisms of action at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4, 2019. Data will highlight Pfizer’s cutting-edge approach, expertise in precision medicine and work in immunotherapy combinations, including company-sponsored and collaborative research studies.

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5/15/19 6:45am EDT
Pfizer Announces Positive Top-Line Results from Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib (PF-04965842), in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

Study achieves all co-primary and secondary endpoints

Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD).

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5/14/19 6:45pm EDT
FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma

  • BAVENCIO is the first anti-PD-L1 in combination with INLYTA approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC)
  • Phase III study showed combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib
  • Combination approved based on Phase III data in an overall population that included patients regardless of PD-L1 expression and across favorable, intermediate and poor prognostic groups 
  • Additional regulatory reviews for BAVENCIO plus INLYTA in advanced RCC are underway worldwide, including in the European Union and Japan
 

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

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5/9/19 7:00am EDT
Pfizer Opens New State-Of-The-Art Biologics Clinical Manufacturing Facility In Andover, Massachusetts

Pfizer Inc. announced today the opening of a new 175,000 square-foot manufacturing facility in Andover, Mass. Pfizer’s Andover site houses commercial manufacturing and product development functions, with colleagues dedicated to the development and production of high-quality complex biologics and vaccines. With its modular and flexible design, the newly opened Andover Clinical Manufacturing Facility (ACMF) will expand the capacity for Pfizer’s BioTherapeutics Pharmaceutical Sciences organization to manufacture clinical supplies. 

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5/8/19 6:45am EDT
Pfizer Acquires Clinical-Stage Biotech Therachon

Expands Pfizer’s rare disease portfolio with potential first-in-class therapy for achondroplasia, a genetic condition and the most common form of short-limb dwarfism

NEW YORK & BASEL, Switzerland--(BUSINESS WIRE)-- Pfizer (NYSE: PFE) today announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia and short bowel syndrome (SBS). Under the terms of the agreement, Pfizer will acquire Therachon for $340 million upfront with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46 for the treatment of achondroplasia, a genetic condition and the most common form of short-limbed dwarfism. Achondroplasia can result in serious cardiovascular, neurological and metabolic complications for approximately 250,000 people worldwide. There are currently no approved treatments for achondroplasia.

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5/7/19 7:00am EDT
European Commission Approves LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer

Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) granted conditional marketing authorization for LORVIQUA® (lorlatinib, available in the U.S., Canada and Japan under the brand name LORBRENA®), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI. LORVIQUA is a third-generation ALK TKI that was specifically developed to penetrate the blood brain barrier, in the presence or absence of resistance mutations.

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5/6/19 6:45am EDT
U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease

— First and only medicines approved for patients with either wild-type or hereditary transthyretin amyloid cardiomyopathy —

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL® (tafamidis meglumine) and VYNDAMAX (tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM.

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4/30/19 6:45am EDT
PFIZER REPORTS FIRST-QUARTER 2019 RESULTS

First-Quarter 2019 Revenues of $13.1 Billion, Reflecting 5% Operational Growth Driven by 7% Operational Growth from Pfizer Biopharmaceuticals Group and 1% Operational Growth From Upjohn First-Quarter 2019 Reported Diluted EPS(1) of $0.68, Adjusted Diluted EPS(2) of $0.85 Raised Midpoint of 2019 Adjusted Diluted EPS(2) Guidance Range by $0.01 to $2.83 to $2.93, Primarily Reflecting Adjusted Other Income(2) Recorded During First-Quarter 2019, Partially Offset by the Unfavorable Impact of Foreign Exchange Reaffirmed 2019 Financial Guidance for Revenues

Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter 2019 and raised the midpoint of its 2019 financial guidance for adjusted diluted EPS(2).

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4/26/19 11:00am EDT
Pfizer Receives Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor in gBRCA-mutated advanced breast cancer

Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU). The indication the CHMP adopted is for TALZENNA as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

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4/25/19 11:17am EDT
Pfizer Hosts Annual Meeting of Shareholders

Declares 36-Cent Second-Quarter 2019 Dividend

The board of directors of Pfizer Inc. today declared a 36-cent second-quarter 2019 dividend on the company’s common stock, payable June 7, 2019 to shareholders of record at the close of business on May 10, 2019. The second-quarter 2019 cash dividend will be the 322nd consecutive quarterly dividend paid by Pfizer.

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4/18/19 5:05pm EDT
Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis

NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The tanezumab 5 mg treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs. Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs. In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was statistically significant. Joint safety was a composite measure consisting of adjudicated outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type 2, subchondral insufficiency fracture, osteonecrosis or pathological fracture. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.

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4/18/19 2:00pm EDT
Pfizer Invites Public to Listen to Webcast of April 25 Annual Meeting of Shareholders

Pfizer Inc. invites investors and the general public to listen to an audio webcast of the Annual Meeting of Shareholders at 9:00 a.m. Eastern Daylight Time on Thursday, April 25, 2019. To pre-register and access the live audio webcast, visit https://investors.pfizer.com/proxy and click on the “Meeting Webcast” button. Pre-registration begins today.

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4/13/19 4:00am EDT
Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

The U.S. FDA awarded Breakthrough Therapy Designation for this potential indication based on these Phase 2 data - - - The Biologics License Application is expected to be submitted to the U.S. FDA by the end of 2020, subject to the successful completion of Phase 3 studies

Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

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4/4/19 2:57pm EDT
U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Approval of expanded indication based predominately on real-world data

Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for IBRANCE® (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database.

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4/3/19 9:42am EDT
VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

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4/2/19 7:00am EDT
Sangamo and Pfizer Announce Phase 1/2 Interim Data for Investigational Hemophilia A Gene Therapy

Eight patients treated with SB-525 gene therapy showed dose-dependent increases in FVIII activity, with the two patients treated with the 3e13 vg/kg dose reaching normal FVIII levels Safety Monitoring Committee recommended expansion of the 3e13 vg/kg dose cohort

BRISBANE, Calif. & Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. Data indicate that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) levels across the four dosage cohorts. Eight patients total were dosed. Based on these results, the Safety Monitoring Committee (SMC) recommended cohort expansion at the 3e13 vg/kg dose. Further details will be disclosed during Sangamo’s conference call and webcast scheduled for 8:00 a.m. ET today, which can be accessed on the Sangamo website.

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3/20/19 6:45am EDT
Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics

Pfizer and Vivet to collaborate on development of potential breakthrough therapy for Wilson disease Pfizer acquires 15% ownership stake in Vivet

PARIS &  Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease.

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3/19/19 6:39pm EST
Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer

Darmstadt, Germany and New York, US, March 19, 2019 – Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib,* a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The alliance has notified health authorities and trial investigators of the decision to discontinue the trial.

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3/19/19 10:00am EDT
Pfizer Invites Public to View and Listen to Webcast of April 30 Conference Call with Analysts

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, April 30, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2019 Performance Report, to be issued that morning.

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