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Recent Pfizer Press Releases

9/20/19 7:55am EST
CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

Not intended for UK-based media

Rockland, MA and New York, US, September 20, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and 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 approval of BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). 

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9/19/19 7:38am EDT
Pfizer Presents Scientific Advancements in Cancer Care at the ESMO Congress 2019 Highlighting Expanded Portfolio

Presentations of interest include a late-breaking abstract on expanded Phase 3 data in BRAF-mutant metastatic colorectal cancer

Pfizer Inc. (NYSE: PFE) is presenting data across its industry-leading oncology portfolio, including company-sponsored and collaborative research studies, spanning 11 therapies in 22 types of cancer, at the European Society for Medical Oncology (ESMO) Congress to be held in Barcelona, Spain, September 27 - October 1, 2019. Data from nearly 50 abstracts involving Pfizer cancer medicines will illustrate the diversity of the portfolio and the company’s cutting-edge scientific approach. For the first time, this will include data presentations on compounds from the acquisition of Array Biopharma Inc.

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9/17/19 10:00am EDT
Pfizer Invites Public to View and Listen to Webcast of October 29 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, October 29, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2019 Performance Report, to be issued that morning.

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9/9/19 8:00am EDT
Pfizer Announces Positive Preliminary Results from a Proof-of-Concept Phase 2 Study (B7471003) of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Otitis Media in Healthy Infants

Additionally, Pfizer Has Completed Enrollment of its Phase 3 Studies (NCT03828617, NCT03835975 and NCT03760146) for its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

Pfizer Inc. (NYSE: PFE) announced today positive preliminary results following administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

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9/3/19 10:00am EDT
Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference

Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply and Business Operations, at the Morgan Stanley 17th Annual Global Healthcare Conference on Monday, September 9, 2019 at 3:40 p.m. Eastern Daylight Time.

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8/21/19 2:00pm EDT
U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer

XTANDI Supplemental New Drug Application (sNDA) Seeks to Add an Indication for Men with Prostate Cancer that Has Spread but Is Sensitive to Hormone Therapy

TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC).

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8/21/19 10:00am EDT
Pfizer Invests Half Billion Dollars to Advance State-of-the-Art Gene Therapy Facility in Sanford, North Carolina

Pfizer announced today an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility is anticipated to support Pfizer’s continuing investment in gene therapy research and development, similar to Pfizer’s Chapel Hill and Kit Creek, North Carolina research and development sites. This facility would expand the company’s presence in North Carolina, where there are currently more than 3,600 Pfizer colleagues, including 650 in Sanford. The expanded facility is projected to add approximately 300 new jobs.

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8/20/19 7:00am EDT
The Pfizer Foundation Invests in 20 Organizations Tackling Infectious Diseases and Antimicrobial Resistance

Grants to help strengthen health systems and reduce health disparities in underserved communities in Africa, Asia and Latin America

Globally, infectious diseases are responsible for an estimated 8.4 million deaths annually and are a leading cause of death worldwide, particularly among young children and marginalized populations in underserved communities,1 often perpetuating the cycle of poverty. It is estimated that the rise of AMR, which occurs when pathogens evolve to withstand the effect of even the most effective medicines, now accounts for approximately 700,000 of these deaths.2 Without action, this number could reach ten million deaths per year by 2050,2 and could cost the world an estimated US $100 trillion in lost productivity in the same amount of time.3 The World Health Organization (WHO) included AMR in its list of ten threats to global health in 2019.4

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8/2/19 6:49pm EDT
Pfizer Announces Phase 3 Top-Line Results for Rivipansel in Patients with Sickle Cell Disease Experiencing a Vaso-Occlusive Crisis

Pfizer Inc. (NYSE:PFE) announced today that the Phase 3 Rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids. The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids.

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8/1/19 12:15am EDT
Pfizer Announces Closing of Joint Venture With GlaxoSmithKline to Create a Premier Global Consumer Healthcare Company

Combined brand portfolio forms the world's largest over-the-counter business with leadership positions in Pain Relief, Respiratory and Vitamins, Minerals and Supplements, and Therapeutic Oral Health

Pfizer Inc. (NYSE: PFE) today announced the closing of its joint venture with GlaxoSmithKline plc (NYSE: GSK) to combine the parties’ respective consumer healthcare businesses to create the world’s largest over-the-counter (OTC) business with robust iconic brands. As previously announced, under the terms of the transaction, Pfizer owns a 32% equity stake in the joint venture and GSK owns 68%. The combined business, which will operate globally as GSK Consumer Healthcare, will be led by CEO Brian McNamara.

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7/30/19 8:16am EDT
Pfizer Completes Acquisition of Array Biopharma

Strengthens Pfizer’s innovative biopharmaceutical business and category leadership in Oncology Expected acceleration of Pfizer’s long-term growth trajectory through new medicines, including the breakthrough combination of BRAFTOVI® and MEKTOVI® Highly productive research unit in Boulder, CO now part of Pfizer’s research network

Pfizer Inc. (NYSE:PFE) today announced the successful completion of its acquisition of Array BioPharma Inc., advancing breakthrough science for the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need.

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7/29/19 6:50am EDT
Pfizer Inc. Reschedules Second-Quarter 2019 Earnings Conference Call to July 29, 2019 at 10:30 a.m. EDT

 

Due to today’s announcement of a proposed transaction between Pfizer and Mylan, Pfizer’s second-quarter 2019 earnings conference call with investment analysts has been rescheduled for today, July 29, 2019, at 10:30 a.m. EDT. This call was previously scheduled for Tuesday, July 30, 2019 at 10 a.m. EDT.

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7/29/19 6:46am EDT
PFIZER REPORTS SECOND-QUARTER 2019 RESULTS 

Second-Quarter 2019 Revenues of $13.3 Billion, Reflecting 2% Operational Growth Driven by 6% Operational Growth from Pfizer Biopharmaceuticals Group Second-Quarter 2019 Reported Diluted EPS(1) of $0.89, Adjusted Diluted EPS(2) of $0.80 Updated 2019 Financial Guidance Primarily to Reflect the Anticipated August 1, 2019 Formation of the Consumer Healthcare Joint Venture with GlaxoSmithKline plc(3) and the Anticipated Near-Term Completion of the Array BioPharma Inc. Acquisition Announces Reverse Morris Trust Transaction to Combine Upjohn and Mylan, Creating a New Global Pharmaceutical Company  

Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2019 and updated certain components of its 2019 financial guidance.

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7/29/19 6:45am EDT
Mylan and Upjohn, a Division of Pfizer, to Combine, Creating a New Champion for Global Health Uniquely Positioned to Fulfill the World’s Need for Medicine

Delivers enhanced global scale and geographic reach, including leading positions in China and other emerging markets Combines Mylan’s sustainable, diverse and differentiated portfolio of medicines with Upjohn’s trusted, iconic brands Creates powerful platform comprising Mylan’s pipeline engine and supply chain and Upjohn’s commercial and medical infrastructure and expertise Focused on driving returns through consistent cash flow growth, an attractive dividend and shareholder-focused capital policies Commitment to solid investment grade ratings Domiciled in the U.S. and governed by Delaware law Robert J. Coury named Executive Chairman of the new company; Michael Goettler named CEO and Rajiv Malik named President Concludes work of Mylan’s Strategic Review Committee Mylan and Pfizer will host Investor Conference Call, Monday, July 29, 2019 at 8:30 AM Eastern Daylight Time

HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction.

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7/23/19 1:48pm EDT
FDA Approves Pfizer’s Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2

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7/5/19 11:15pm EDT
Sangamo and Pfizer Announce Updated Phase 1/2 Results for SB-525 Investigational Hemophilia A Gene Therapy Showing Sustained Increased Factor VIII Levels

Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A.

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7/1/19 10:00am EDT
Pfizer Completes Acquisition of Therachon

Early clinical development program for achondroplasia augments Pfizer’s Rare Disease portfolio

Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the terms of the transaction, Pfizer acquired Therachon for $340 million with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46. TA-46 is an investigational medicine for the treatment of achondroplasia, a genetic condition and the most common form of short-limb dwarfism. There are currently no approved treatment options for achondroplasia.

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7/1/19 8:00am EDT
Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis

Data show crisaborole ointment, 2%, a steroid-free topical treatment, was well-tolerated over 4-week treatment period Safety profile consistent with previous clinical trial experience

Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.1 Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.2,3,4,5

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6/28/19 4:05pm EDT
Pfizer Announces Results from Phase 3 Trial of Revatio® (Sildenafil Citrate) in Newborns with Persistent Pulmonary Hypertension

Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).

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6/28/19 10:15am EDT
Pfizer Presents Initial Clinical Data on Phase 1b Gene Therapy Study for Duchenne Muscular Dystrophy (DMD)

Pfizer Inc. (NYSE:PFE) will present initial Phase 1b clinical data on PF-06939926, an investigational gene therapy to potentially treat Duchenne muscular dystrophy (DMD) at the 25th Annual Parent Project Muscular Dystrophy (PPMD) Connect Conference in Orlando, FL. These are preliminary data drawn from a small number of participants in an ongoing study.

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