Pfizer Inc. (N:PFE)

Business Focus: Pharmaceuticals

Aug 21, 2019 02:00 pm ET
U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
TOKYO and NEW YORK, Aug. 21, 2019 /PRNewswire/ -- 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 improve...
Aug 21, 2019 02:00 pm ET
U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
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 t
Aug 21, 2019 10:00 am ET
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
Aug 02, 2019 06:49 pm ET
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 requ
Jul 30, 2019 08:16 am ET
Pfizer Completes Acquisition of Array Biopharma
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.
Jul 29, 2019 08:01 pm ET
SHAREHOLDER ALERT: WeissLaw LLP Investigates Mylan N.V.
NEW YORK, July 29, 2019 /PRNewswire/ -- WeissLaw LLP  is investigating possible breaches of fiduciary duty and other violations of law by the Board of Directors of Mylan N.V. ("Mylan" or the "Company") (NASDAQ: MYL) in connection with the proposed acquisition of the Company by Pfizer Inc. ("Pfizer") (NYSE: PFE).  Under the terms of the agreement, Mylan shareholders will own a meager 43% of the combined company....
Jul 29, 2019 06:50 am ET
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.
Jul 29, 2019 06:46 am ET
PFIZER REPORTS SECOND-QUARTER 2019 RESULTS 
Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2019 and updated certain components of its 2019 financial guidance.
Jul 29, 2019 06:45 am ET
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
HERTFORDSHIRE, England and PITTSBURGH and NEW YORK, July 29, 2019 /PRNewswire/ -- 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%....
Jul 29, 2019 06:45 am ET
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
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 tran
Jul 23, 2019 01:48 pm ET
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
Jul 05, 2019 11:15 pm ET
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. The data showed that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) activity levels. The first two patients treated at the 3e13 vg/kg dose rapidly achieved normal levels of FVIII activity as measured using a chromogenic assay, with no reported bleeding events, and the response continues to be durable for as lo
Jul 01, 2019 10:00 am ET
Pfizer Completes Acquisition of Therachon
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 acho
Jul 01, 2019 08:00 am ET
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
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 t
Jun 28, 2019 04:05 pm ET
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).
Jun 28, 2019 10:15 am ET
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.
Jun 28, 2019 07:33 am ET
Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.2
Jun 27, 2019 04:17 pm ET
Scott Gottlieb Elected to Pfizer’s Board of Directors
Pfizer Inc. (NYSE:PFE) today announced the election of Dr. Scott Gottlieb to its Board of Directors, effective immediately. Dr. Gottlieb, age 47, was also appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s Board.
Jun 27, 2019 04:15 pm ET
Pfizer Declares Third-Quarter 2019 Dividend
The Board of Directors of Pfizer Inc. today declared a 36-cent third-quarter 2019 dividend on the company’s common stock, payable September 3, 2019, to holders of the Common Stock of record at the close of business on August 2, 2019. Pfizer maintained the dividend from the second-quarter at 36 cents per share. The third-quarter 2019 cash dividend will be the 323rd consecutive quarterly dividend paid by Pfizer.
Jun 21, 2019 10:50 pm ET
PFIZER INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Pfizer Inc. - PFE
Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Pfizer Inc. (NYSE: PFE).
Jun 18, 2019 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of July 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, July 30, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2019 Performance Report, to be issued that morning.
Jun 17, 2019 11:59 am ET
SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Investors of an Investigation Regarding Whether the Sale of Array BioPharma Inc. to Pfizer Inc. is Fair to Shareholders
The following statement is being issued by Levi & Korsinsky, LLP: To: All Persons or Entities who purchased Array BioPharma Inc. (“Array BioPharma” or the “Company”) (NASDAQGM: ARRY) stock prior to June 17, 2019. You are hereby notified that Levi...
Jun 17, 2019 10:43 am ET
ARRAY BIOPHARMA INC. SHAREHOLDER ALERT: Rigrodsky & Long, P.A. Announces Investigation Of Buyout
Rigrodsky & Long, P.A.: Do you own shares of Array BioPharma Inc. (NASDAQ GM: ARRY)? Did you purchase any of your shares prior to June 17, 2019?Do you think the proposed buyout is fair?Do you want to discuss your rights?  Rigrodsky & Long, P.A....
Jun 17, 2019 06:45 am ET
Pfizer to Acquire Array BioPharma
Pfizer Inc. (NYSE: PFE) and Array BioPharma Inc. (NASDAQ: ARRY) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have
Jun 12, 2019 08:00 am ET
Pfizer Announces Results from XELJANZ® XR (tofacitinib) ORAL Shift Study, The First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor
Pfizer Inc. (NYSE:PFE) announced today positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX. The study demonstrated no
Jun 05, 2019 01:30 pm ET
Jeff Settleman, Ph.D., Joins Pfizer to Lead Oncology Research & Development
Pfizer Inc. (NYSE: PFE) announced today that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer,
Jun 03, 2019 08:05 am ET
Matinas BioPharma to Present at the 9th Annual LD Micro Invitational
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company, today announced that Jerome D. Jabbour, Chief Executive Officer, has been invited to present at the 9th Annual LD Micro Invitational investor conference...
May 24, 2019 10:50 pm ET
PFIZER INVESTIGATION INITIATED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Pfizer Inc. - PFE
Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Pfizer Inc. (NYSE: PFE).
May 24, 2019 04:00 pm ET
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).
May 15, 2019 05:01 pm ET
Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting
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.
May 15, 2019 07:00 am ET
Matinas BioPharma Announces a Research Collaboration with ViiV Healthcare to Evaluate Formulation of Antiviral Drug Candidates
Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), today announced that they have entered into a research collaboration with ViiV Healthcare, a global specialist HIV company established in November of 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer...
May 15, 2019 06:45 am ET
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
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).
May 14, 2019 07:44 pm ET
May 14, 2019 09:31 am ET
InvestorsObserver releases stock and option data on American Airlines, Apple, JPMorgan Chase, NVIDIA, and Pfizer
NEW YORK, May 14, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AAL, AAPL, JPM, NVDA, and PFE....
May 08, 2019 06:45 am ET
Pfizer Acquires Clinical-Stage Biotech Therachon
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
May 06, 2019 06:45 am ET
U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease
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
Apr 30, 2019 06:45 am ET
PFIZER REPORTS FIRST-QUARTER 2019 RESULTS
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).
Apr 25, 2019 11:17 am ET
Pfizer Hosts Annual Meeting of Shareholders
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.
Apr 18, 2019 05:05 pm ET
Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis
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 fu
Apr 18, 2019 02:00 pm ET
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 “Meetin
Apr 13, 2019 04:00 am ET
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 A
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
Apr 04, 2019 02:57 pm ET
U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer
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 s
Apr 04, 2019 10:04 am ET
AM Best Affirms Credit Ratings of Blue Whale Re Ltd.
AM Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a+” of Blue Whale Re Ltd. (Blue Whale) (Burlington, VT). The outlook of these Credit Ratings (ratings) is stable.
Apr 02, 2019 07:00 am ET
Sangamo and Pfizer Announce Phase 1/2 Interim Data For Investigational Hemophilia A Gene Therapy
BRISBANE, Calif. and NEW YORK, April 2, 2019 /PRNewswire/ -- 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...
Apr 02, 2019 07:00 am ET
Sangamo and Pfizer Announce Phase 1/2 Interim Data for Investigational Hemophilia A Gene Therapy
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 deta
Mar 25, 2019 10:53 am ET
S&P 500 Q4 2018 Buybacks Set 4th Consecutive Quarterly Record at $223 Billion; 2018 Sets Record $806 Billion
NEW YORK, March 25, 2019 /PRNewswire/ -- S&P Dow Jones Indices ("S&P DJI") announced today that preliminary Q4 2018 S&P 500® stock buybacks, or share repurchases, set a fourth consecutive record of $223.0 billion. This displaces the previous record of $203.8 billion, set during Q3 2018 and is a 62.8% increase from the $137.0 billion reported for Q4 2017. ...
Mar 20, 2019 06:45 am ET
Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics
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.
Mar 19, 2019 10:00 am ET
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.
Mar 17, 2019 11:45 am ET
Mar 12, 2019 09:31 am ET
Option-trading opportunities on Altaba Inc., Apple Inc., The Coca-Cola Co., Pfizer Inc., and Sea Limited
NEW YORK, March 12, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AABA, AAPL, KO, PFE, and SE....
Mar 11, 2019 07:37 pm ET
U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA™ (trastuzumab-qyyp), a Biosimilar to Herceptin®1
Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2
Mar 05, 2019 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Andy Schmeltz, Global President, Oncology, and Chris Boshoff, Chief Development Officer, Oncology, at the Cowen and Company 39th Annual Healthcare Conference on Tuesday, March 12, 2019 at 9:20 a.m. Eastern Daylight Time.
Mar 05, 2019 09:05 am ET
AnTolRx Announces Pfizer Exercises Option To License Immune Tolerance Therapy For Potential Treatment Of Type 1 Diabetes
CAMBRIDGE, Mass., March 5, 2019 /PRNewswire/ -- AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. (NYSE: PFE) has exercised the option granted under a June 2016 agreement to license an immune tolerance therapy from AnTolRx's Type 1 diabetes research program. ...
Mar 04, 2019 08:57 pm ET
Pfizer Prices $5,000,000,000 Debt Offering
Pfizer Inc. (NYSE: PFE) today announced the pricing of a debt offering consisting of five tranches of notes:
Mar 04, 2019 08:20 am ET
Market Trends Toward New Normal in Pfizer, Hyatt Hotels, Wipro, Garmin, Ameren, and Qorvo — Emerging Consolidated Expectations, Analyst Ratings
In new independent research reports released early this morning, Capital Review released its latest key findings for all current investors, traders, and shareholders of Pfizer Inc. (NYSE:PFE), Hyatt Hotels Corporation (NYSE:H), Wipro Limited...
Mar 04, 2019 08:00 am ET
BioXcel Therapeutics Announces Addition of Merck KGaA, Darmstadt, Germany, and Pfizer to Clinical Collaboration with Nektar for Development of Triple-combination Therapy in Pancreatic Cancer
BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced the addition of Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the USA and Canada, and Pfizer Inc. (NYSE: PFE) to its Nektar...
Feb 28, 2019 08:00 am ET
Pfizer Announces Serotypes Included in 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 the new serotypes included in 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 covered in the vaccine in adults aged 18 years and older. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) plus 7 additional serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F).
Feb 19, 2019 10:30 am ET
Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials
Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner — through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research — will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.
Feb 19, 2019 09:32 am ET
Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®*
Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.1,2
Feb 19, 2019 07:30 am ET
Gliknik To Receive $15 Million Milestone Payment From Pfizer Inc. Following Clinical Progress With PF-06755347, Previously Known As GL-2045
BALTIMORE, Feb. 19, 2019 /PRNewswire/ -- Gliknik Inc. today announced that it will receive a $15 million milestone payment from Pfizer Inc. (NYSE: PFE) following the start of a Phase I clinical trial of Pfizer drug candidate PF-06755347, previously known as GL-2045, for the potential treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder. Gliknik and Pfizer entered into an exclusive worldwide licensing agreement in 2013. ...
Feb 19, 2019 05:45 am ET
Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain
NEW YORK and INDIANAPOLIS, Feb. 19, 2019 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo. The tanezumab 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis. Full r...
Feb 11, 2019 05:00 pm ET
Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.1 Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.2
Feb 11, 2019 04:00 pm ET
Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer
NEW YORK and TOKYO, Feb. 11, 2019 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.1 Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.2...
Jan 29, 2019 06:45 am ET
PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2018 RESULTS
Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2018 and provided 2019 financial guidance.
Jan 29, 2019 06:30 am ET
Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA compared to those receiving placebo. The tanezumab 2.5 mg treatment arm met two of the three protocol-defined co
Jan 14, 2019 08:00 am ET
US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition.1,2
Jan 03, 2019 08:30 am ET
Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata
Pfizer Inc. (NYSE: PFE) announced today the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies.1,2
Dec 31, 2018 10:00 am ET
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 Albert Bourla, Chief Operating Officer, and Mikael Dolsten, President, Worldwide Research and Development, at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 8:30 a.m. Pacific Standard Time. Effective January 1, 2019, Albert Bourla will become Chief Executive Officer.
Dec 27, 2018 10:00 am ET
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 Albert Bourla, Chief Operating Officer, at the Goldman Sachs 11th Annual Healthcare CEOs Unscripted: A View from the Top on Thursday, January 3, 2019 at 10:15 a.m. Eastern Standard Time. Effective January 1, 2019, Albert Bourla will become Chief Executive Officer.
Dec 20, 2018 04:30 pm ET
Independent Data Monitoring Committee Recommends Discontinuation of the Phase 2b STRIVE Clinical Trial of Staphylococcus aureus Vaccine Following Planned Interim Analysis
Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) is being discontinued due to futility. This decision is based on a recommendation from an independent Data Monitoring Committee (DMC), composed of external experts, after conducting a pre-planned interim analysis.
Dec 20, 2018 08:41 am ET
Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving radiographic progression-free survival (rPFS) versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (C
Dec 20, 2018 08:00 am ET
Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer
TOKYO and NEW YORK, Dec. 20, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, significantly improving radiographic progression-free survival (rPFS) versus ADT alone. The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials i...
Dec 19, 2018 08:31 am ET
Thinking about buying stock in Aurora Cannabis Inc, Biocept Inc, Cronos Group Inc, General Mills, Inc., or Pfizer Inc.?
NEW YORK, Dec. 19, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ACB, BIOC, CRON, GIS, and PFE....
Dec 19, 2018 02:03 am ET
Pfizer and GlaxoSmithKline Announce Joint Venture to Create a Premier Global Consumer Healthcare Company
Pfizer Inc. (NYSE: PFE) and GlaxoSmithKline plc (NYSE:GSK) today announced they have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion.
Dec 18, 2018 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of January 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. EST on Tuesday, January 29, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter 2018 Performance Report, to be issued that morning.
Dec 17, 2018 07:00 am ET
Kineta Enters Research Collaboration and License Agreement with Pfizer to Develop New Cancer Immunotherapies
SEATTLE, Dec. 17, 2018 /PRNewswire/ -- Kineta Immuno-Oncology, LLC (KIO), a subsidiary of Kineta, Inc., today announced that it has entered into a strategic research collaboration with Pfizer Inc. (NYSE:PFE) to develop RIG-I agonist immunotherapies for the treatment of cancer.  The research collaboration and license agreement grants to Pfizer the exclusive rights to KIO's RIG-I screening platform and related compounds and technologies.  The companies will collaborate to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic...
Dec 14, 2018 12:10 pm ET
Pfizer Declares First-Quarter 2019 Dividend
The board of directors of Pfizer Inc. today declared a 36-cent first-quarter 2019 dividend on the company’s common stock, payable March 1, 2019, to shareholders of record at the close of business on February 1, 2019. Pfizer increased the dividend by approximately 6 percent, to 36 cents from 34 cents per share. The first-quarter 2019 cash dividend will be the 321st consecutive quarterly dividend paid by Pfizer.
Dec 14, 2018 10:29 am ET
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV™ (bevacizumab)
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab), a potential biosimilar to Avastin (bevacizumab).1 ZIRABEV is a monoclonal antibody for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal
Dec 14, 2018 08:00 am ET
Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
Pfizer Inc. (NYSE:PFE) announced today the initiation of a Phase 3 program for its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.
Dec 12, 2018 07:20 am ET
Report: Developing Opportunities within Pfizer, Bed Bath & Beyond, Vishay Intertechnology, Cloudera, Markel, and QTS Realty Trust — Future Expectations, Projections Moving into 2018
In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Pfizer Inc. (NYSE:PFE), Bed Bath & Beyond Inc. (NASDAQ:BBBY), Vishay...
Dec 11, 2018 09:34 am ET
Thinking about buying stock in Caterpillar Inc., DSW Inc., Innovate Bio, Oncosec Medical or Pfizer Inc.?
NEW YORK, Dec. 11, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for CAT, DSW, INNT, ONCS, and PFE....
Dec 03, 2018 08:31 am ET
Option-trading strategies for Advanced Micro Devices, Cisco Systems, Dicks Sporting Goods, Intel, and Pfizer Inc.
CHICAGO, Dec. 3, 2018 /PRNewswire/ -- InvestorsObserver issues option trade ideas for AMD, CSCO, DKS, INTC, and PFE....
Dec 02, 2018 03:45 pm ET
Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hematology Annual Meeting
Pfizer Inc. (NYSE:PFE) announced today at the American Society of Hematology Annual Meeting that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan®/MabThera® (rituximab-EU)i, met its primary endpoint of overall response rate (ORR) at Week 26 of the 52-week study.1
Nov 30, 2018 10:00 am ET
Pfizer Reaches a Global Agreement with AbbVie
Pfizer Inc. (NYSE:PFE) today announced that it has signed licensing agreements with AbbVie, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar. Under the terms of the agreements, AbbVie grants Pfizer a non-exclusive patent license for the use and sale of Pfizer’s proposed adalimumab biosimilar for many countries around the world.
Nov 27, 2018 03:01 pm ET
Pfizer Receives Six Months Pediatric Exclusivity for LYRICA® (pregabalin)
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for LYRICA®. This grant extends the period of U.S. market exclusivity for LYRICA by an additional six months, to June 30, 2019.
Nov 21, 2018 01:40 pm ET
U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved DAURISMO™ (glasdegib), a once-daily oral medicine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is taken in combination with low-dose cytarabine (LDAC), a type of chemotherapy. DAURISMO has not been studied in patients with severe renal impairment or moderate-to-severe hepatic impairment.1
Nov 21, 2018 10:00 am ET
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 Chris Boshoff, senior vice president and head, Immuno-Oncology, Early Development and Translational Oncology, at the Evercore ISI HealthConX Conference on Wednesday, November 28, 2018 at 8:45 a.m. EST.
Nov 06, 2018 07:30 am ET
New Clinical Oncology Collaboration Between Nektar and Pfizer to Evaluate Combination of NKTR-214, a CD122-Biased Agonist, with Avelumab and Talazoparib or Enzalutamide in Multiple Cancers
SAN FRANCISCO, Nov. 6, 2018 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced that it has entered into an oncology clinical collaboration with Pfizer Inc. (NYSE:PFE) to evaluate several combination regimens in multiple cancer settings, including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). The collaboration will evaluate Nektar's lead immuno-oncology candidate, the CD122-biased agonist NKTR-214 with avelumab, a human anti-PD-L1 antibody in development by Merck KGaA, Darmstadt, Germany, and Pfizer; talazoparib, a p...
Nov 02, 2018 04:42 pm ET
U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication is approved un
Nov 02, 2018 08:10 am ET
Report: Exploring Fundamental Drivers Behind Pfizer, eBay, ABM Industries, Quad Graphics, FireEye, and BJ's Restaurants — New Horizons, Emerging Trends, and Upcoming Developments
In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Pfizer Inc. (NYSE:PFE), eBay Inc. (NASDAQ:EBAY), ABM Industries...
Oct 30, 2018 06:45 am ET
PFIZER REPORTS THIRD-QUARTER 2018 RESULTS
Pfizer Inc. (NYSE:PFE) reported financial results for third-quarter 2018 and narrowed certain 2018 financial guidance ranges.
Oct 29, 2018 02:15 am ET
Pfizer Announces Clinical Development Agreement with Novartis to Advance the Treatment of NASH
Pfizer Inc. (NYSE:PFE) announced today that it has entered into a non-exclusive clinical development agreement with Novartis (NYSE: NVS) to investigate one or more combination therapies for the treatment of non-alcoholic steatohepatitis (NASH). The companies will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in Phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, Phase 1) and a Ketohexokinase (KHK)
Oct 23, 2018 06:40 pm ET
Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced complete results from a Phase 3 study evaluating the efficacy and safety of subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, in patients with osteoarthritis (OA) pain treated for 16 weeks. The study met all three co-primary efficacy endpoints, demonstrating that among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement
Oct 20, 2018 10:30 am ET
Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer
Pfizer Inc.(NYSE:PFE) today announced detailed overall survival (OS) data from the PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease progressed on or after prior endocrine therapy. In the study, there was a numerical improvement in OS of nearly seven months with IBRANCE plus fulvestrant compared to placebo plus fulvestrant, althoug
Oct 09, 2018 09:05 am ET
Pfizer Announces Executive Leadership Team
Pfizer Inc. (NYSE:PFE) today announced its executive team that will report to Albert Bourla, incoming Chief Executive Officer, coincident with the commencement of his new role effective January 1, 2019.
Oct 01, 2018 09:48 am ET
Thinking about buying stock in Apple, Facebook, Goldman Sachs, Pfizer or Tesla?
NEW YORK, Oct. 1, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AAPL, FB, GS, PFE, and TSLA....
Oct 01, 2018 06:45 am ET
Pfizer Announces CEO Succession
Pfizer Inc. (NYSE:PFE) today announced its Board of Directors has unanimously elected Dr. Albert Bourla, 56, Pfizer Chief Operating Officer (COO), to succeed Ian Read as CEO effective January 1, 2019. Ian Read will transition from his current role as Chairman and CEO to Executive Chairman of Pfizer’s Board of Directors.
Sep 27, 2018 05:41 pm ET
U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
Sep 27, 2018 01:09 pm ET
Pfizer Declares 34-Cent Fourth-Quarter 2018 Dividend
The board of directors of Pfizer Inc. today declared a 34-cent fourth-quarter 2018 dividend on the company’s common stock, payable December 3, 2018, to shareholders of record at the close of business on November 9, 2018. The third-quarter 2018 cash dividend will be the 320th consecutive quarterly dividend paid by Pfizer.
Sep 25, 2018 08:50 am ET
Factors of Influence in 2018, Key Indicators and Opportunity within Dorchester Minerals, Teladoc, Pfizer, Intercontinental Exchange, General Electric, and Prospect Capital — New Research Emphasizes Ec
In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Dorchester Minerals, L.P. (NASDAQ:DMLP), Teladoc, Inc. (NYSE:TDOC), Pfizer...
Sep 24, 2018 09:00 am ET
Astellas Receives Positive CHMP Opinion for XTANDI® (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer
TOKYO and CHERTSEY, England, Sept. 24, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the indication for Xtandi (enzalutamide) to include adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).2 If approved by the European Commission (EC), enzalutamide will be one of the first treatments approved for this critical stage of disease, currently ass...
Sep 20, 2018 08:00 am ET
Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.
Sep 18, 2018 02:45 pm ET
New Sub-group Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Presented at 2018 HFSA Annual Scientific Meeting
Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 AT
Sep 18, 2018 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of October 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, October 30, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2018 Performance Report, to be issued that morning.
Sep 15, 2018 02:00 am ET
Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the 27th European Academy of Dermatology and Venereology (EADV) Congress
Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata (AA), an autoimmune disease characterized by hair loss and often associated with profound psychological consequences. Both JAK inhibitors met the primary efficacy endpoint in improving hair regrowth on the scalp relative to baseline at week 24 (33.6 points and 49.5 points for JAK3 and TYK2/J
Sep 06, 2018 11:30 am ET
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, Executive Vice President, Business Operations, and Chief Financial Officer, at the Morgan Stanley 16th Annual Global Healthcare Conference on Thursday, September 13, 2018 at 2:55 p.m. Eastern Daylight Time.
Sep 05, 2018 08:50 am ET
Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata
Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.1,2
Sep 04, 2018 08:38 pm ET
Pfizer Prices $5,000,000,000 Debt Offering
Pfizer Inc. (NYSE: PFE) today announced the pricing of a debt offering consisting of six tranches of notes:
Aug 30, 2018 08:00 am ET
Pfizer Terminates Domagrozumab (PF-06252616) Clinical Studies for the Treatment of Duchenne Muscular Dystrophy
Pfizer Inc. (NYSE: PFE) announced today that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and efficacy study (B5161002) and an open-label extension study (B5161004). The Phase 2 study (B5161002), did not meet its primary efficacy endpoint, which was to demonstrate a difference in the mean change from baseline in 4 Stair Climb (in seconds) following one year of treatment with domagrozumab as compared to placebo in patients with DMD. Fu
Aug 27, 2018 05:21 am ET
Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Results Presented as Late-Breaking Data at the ESC Congress 2018
Pfizer Inc. (NYSE:PFE) announced today the primary results from the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, which showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM).1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failu
Aug 22, 2018 05:00 pm ET
Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive Prostate Cancer
NEW YORK and TOKYO, Aug. 22, 2018 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). These amendments accelerate timelines for the anticipated primary completion dates of both trials....
Aug 22, 2018 05:00 pm ET
Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive Prostate Cancer
Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). These amendments accelerate timelines for the anticipated primary completion dates of both trials.
Aug 22, 2018 06:00 am ET
Exact Sciences and Pfizer Enter into U.S. Promotion Agreement for Cologuard®
MADISON, Wis. and NEW YORK, Aug. 22, 2018 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE) today announced an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. Pfizer will join Exact Sciences' sales representatives in reaching both physicians and health systems and will also actively participate in extending and deepening the Cologuard marketing campaign.  ...
Aug 20, 2018 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of August 27 Conference Call with Analysts and Investors to Review Tafamidis Data Presentation at ESC Congress 2018
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts on Monday, August 27, 2018 at 9:00 a.m. EDT. The purpose of the call is to review the Tafamidis data presentation at the ESC Congress 2018 organized by the European Society of Cardiology.
Aug 01, 2018 09:31 am ET
Thinking about buying stock in Apple, Naked Brand Group, Fitbit, Forest City Realty Trust or Pfizer?
CHICAGO, Aug. 1, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AAPL, FCE.A, FIT, NAKD, and PFE....
Aug 01, 2018 01:00 am ET
XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for Moderately to Severely Active Ulcerative Colitis
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.1 XELJANZ is the first and only oral therapy and Janus kinase (JAK) inhibitor to be approved for this
Jul 31, 2018 06:45 am ET
PFIZER REPORTS SECOND-QUARTER 2018 RESULTS
Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2018 and raised 2018 financial guidance for Adjusted diluted EPS(2).
Jul 31, 2018 06:00 am ET
Pfizer Receives European Approval for Oncology Biosimilar, TRAZIMERA™ (trastuzumab)
Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.1
Jul 31, 2018 03:00 am ET
Jul 24, 2018 01:30 pm ET
Pfizer to Build Cutting-Edge Sterile Injectable Facility in Michigan, Investing Nearly Half a Billion Dollars in U.S. Manufacturing, Creating More than 450 Jobs
Pfizer today announced it will increase its commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients around the world.
Jul 24, 2018 05:38 am ET
ViiV Healthcare announces SWORD 100-week data for Juluca (dolutegravir/rilpivirine) at AIDS 2018
ViiV Healthcare today presented 100-week results from its phase III programme evaluating the safety and efficacy of switching virologically-suppressed people living with HIV (PLHIV) from a three or four-drug antiretroviral regimen to a 2-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.)1 These results were presented at the 22nd International AIDS Conference taking place 23-27 July 2018 in Amsterdam.
Jul 24, 2018 05:35 am ET
ViiV Healthcare Presents Phase III Data at AIDS 2018 from Landmark GEMINI Studies Showing Two-Drug Regimen of Dolutegravir and Lamivudine Has Similar Efficacy to a Three-Drug Regimen in Treatment Naïv
ViiV Healthcare today presented at the 22nd International AIDS conference in Amsterdam 48-week results from the phase III GEMINI 1 & 2 studies, assessing the safety and efficacy of a two-drug regimen (2DR) of dolutegravir (DTG) and lamivudine (3TC) compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults with baseline viral loads up to 500,000 copies per millilitre (c/mL).
Jul 20, 2018 04:24 pm ET
U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi)
Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.
Jul 18, 2018 06:45 am ET
Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain
Pfizer Inc.(NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo.
Jul 16, 2018 10:31 am ET
Pfizer Initiates Pivotal Phase 3 Program for Investigational Hemophilia B Gene Therapy
Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the
Jul 13, 2018 02:30 pm ET
U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
TOKYO and NEW YORK, July 13, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral...
Jul 13, 2018 02:30 pm ET
U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and o
Jul 11, 2018 06:45 am ET
Pfizer to Organize for Future Growth
Pfizer Inc. (NYSE:PFE) today announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes will be effective at the beginning of the company’s 2019 fiscal year.
Jul 10, 2018 07:44 pm ET
Pfizer’s Announces It Will Defer Company’s Price Increases
Following an extensive discussion with President Trump today, Pfizer’s Chairman and CEO Ian Read announced that it will defer the company’s price increases that were effective on July 1 to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients. The company will return these prices to their pre-July 1 levels as soon as technically possible, and the prices will remain in effect until the earlier of when the president’s blueprint goes into effect or the end of the year –
Jun 28, 2018 01:49 pm ET
XELJANZ® (tofacitinib citrate) Receives Marketing Authorisation in the European Union for Active Psoriatic Arthritis
Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active Ps
Jun 28, 2018 12:20 pm ET
Pfizer Declares 34-Cent Third-Quarter 2018 Dividend
The board of directors of Pfizer Inc. today declared a 34-cent third-quarter 2018 dividend on the company’s common stock, payable September 4, 2018, to shareholders of record at the close of business on August 3, 2018. The third-quarter 2018 cash dividend will be the 319th consecutive quarterly dividend paid by Pfizer.
Jun 27, 2018 08:00 am ET
U.S. FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy.
Jun 25, 2018 08:00 am ET
Pfizer Announces Overall Survival Results from Phase 3 PALOMA-3 Trial of IBRANCE® (Palbociclib) in HR+, HER2- Metastatic Breast Cancer
Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance.
Jun 19, 2018 10:00 am ET
Pfizer Invites Public To View And Listen To Webcast Of July 31 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, July 31, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2018 Performance Report, to be issued that morning.
Jun 12, 2018 07:00 am ET
Pfizer Announces Extension of Zithromax® Antibiotic Donation Program through 2025 to Help Eliminate World’s Leading Infectious Cause of Blindness
Pfizer Inc. announced today it will extend its donation of the antibiotic Zithromax® (azithromycin) to the International Trachoma Initiative through 2025, building on the company’s 20-years of work to help eliminate the world’s leading infectious cause of blindness. Approximately 163 million people are at risk of developing the disease and this recommitment ensures that Pfizer, through the International Trachoma Initiative (ITI), will continue to provide trachoma endemic countries with donated antibiotics that are a critical compon
Jun 07, 2018 08:00 am ET
U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines
Jun 06, 2018 08:00 am ET
Pfizer to Expand Venture Investing with $600 Million Commitment to Pfizer Ventures
Pfizer Inc. (NYSE:PFE) today announced it plans to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, the company’s venture investment vehicle. In addition to increased funding, Pfizer will extend its leadership as a venture capital investor with an expanded team that leverages expertise across venture capital investing, business development, drug discovery and clinical development.
Jun 04, 2018 05:37 pm ET
Dacomitinib Shows More than Seven-Month Improvement in Overall Survival Compared to an Established Therapy in Advanced NSCLC with EGFR-Activating Mutations
Pfizer Inc. (NYSE:PFE) today announced overall survival (OS) data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations compared to gefitinib. The trial showed a median OS of 34.1 months for patients receiving dacomitinib (95% CI: 29.5, 37.7), representing a more than seven-month improvement compared to 26.8 months with gefitinib (95% CI: 23.7, 32.1). The OS data from ARCHER 1050 were presented today as an oral
Jun 01, 2018 07:30 am ET
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, TRAZIMERA™ (trastuzumab)
Pfizer Inc. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA™, a potential biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1
May 30, 2018 03:52 pm ET
Pfizer Announces U.S. FDA Approves XELJANZ® (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis (UC).1
May 29, 2018 08:00 am ET
Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-p
May 23, 2018 08:00 am ET
FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy
Pfizer Inc. (NYSE:PFE) announced today that tafamidis received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.1,2
May 22, 2018 01:30 pm ET
A Study Analyzing Observational Data Shows Real-World Effectiveness of Prevnar® 13 in Adults Age 65+
Pfizer Inc. (NYSE: PFE) announced today that results from a study analyzing real-world effectiveness data found that Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) reduced the risk of hospitalization from vaccine-type pneumococcal community-acquired pneumonia (CAP) by 73% (95% CI: 12.8−91.5%) in adults aged 65 and older.1 Importantly, Prevnar 13 (PCV13) worked under real-world conditions where people received pneumococcal vaccination as advised by their health care provi
May 22, 2018 08:00 am ET
Pfizer Begins a Phase 1/2 Study to Evaluate Respiratory Syncytial Virus (RSV) Vaccine
Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV is a common respiratory virus that affects the lungs and airways, with significant impact on young children and older adults. The highest risk of severe outcome from RSV occurs in the first months of life.3
May 22, 2018 02:00 am ET
Spark Therapeutics and Pfizer Announce Data from 15 Participants with Hemophilia B Showing Persistent and Sustained Factor IX Levels with No Serious Adverse Events
Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Pfizer (NYSE:PFE), today announced that, with a cumulative follow-up of more than 18 patient years of...
May 21, 2018 06:11 am ET
ViiV Healthcare Receives EU Marketing Authorisation for Juluca (dolutegravir/rilpivirine), the First 2-Drug Regimen, Once-Daily, Single-Pill for the Treatment of HIV
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted marketing authorisation for Juluca (dolutegravir 50mg/rilpivirine 25mg) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA
May 17, 2018 04:51 pm ET
Invacare Corporation Appoints Petra Danielsohn-Weil, PhD, to Board of Directors
Invacare Corporation (NYSE: IVC) today announced the appointment of Petra Danielsohn-Weil, PhD, to its Board of Directors, effective May 17, 2018. From 2014 until her retirement in August 2017, Ms. Danielsohn-Weil was the Regional President for Pfizer Essential Health - Europe, a leader in non-viral anti-infectives, biosimilars and sterile injectable medicines and a unit of Pfizer Inc. (NYSE:PFE), a research-based, global biopharmaceutical company.
May 17, 2018 08:00 am ET
LYRICA® (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint
Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose (7 mg/kg/day) did not result in a statistically
May 16, 2018 05:00 pm ET
Pfizer Oncology to Showcase Clinical Advances from its Growing Portfolio and Research Pipeline at ASCO
Pfizer Inc. today announced that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5, 2018. Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies.
May 15, 2018 02:38 pm ET
Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S.
May 07, 2018 08:00 am ET
Wave Life Sciences Highlights Progress on Hepatic Collaboration with Pfizer
Wave Life Sciences Ltd. (NASDAQ:WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced that Pfizer (NYSE:PFE) recently nominated the fourth and fifth...
May 02, 2018 09:30 am ET
Is now the time to buy, sell, or hold Apple, Advanced Micro Devices, Pfizer, Tenet Healthcare, or Tapestry?
CHICAGO, May 2, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AAPL, AMD, PFE, THC, and TPR....
May 01, 2018 06:45 am ET
PFIZER REPORTS FIRST-QUARTER 2018 RESULTS
Pfizer Inc. (NYSE:PFE) reported financial results for first-quarter 2018 and reaffirmed all components of 2018 financial guidance.
Apr 26, 2018 01:13 pm ET
Pfizer Hosts Annual Meeting of Shareholders
The board of directors of Pfizer Inc. today declared a 34-cent second-quarter 2018 dividend on the company’s common stock, payable June 1, 2018, to shareholders of record at the close of business on May 11, 2018. The second-quarter 2018 cash dividend will be the 318th consecutive quarterly dividend paid by Pfizer.
Apr 23, 2018 08:00 am ET
Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
Pfizer Inc. (NYSE: PFE) today announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB)
Apr 23, 2018 07:45 am ET
Pfizer Provides Update on Proposed Trastuzumab Biosimilar
Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer is working closely with the FDA to address the contents of the letter and remains committed to bringi
Apr 23, 2018 07:30 am ET
MYLOTARG™ Approved In The EU For The Treatment Of Previously Untreated, De Novo, CD33-positive Acute Myeloid Leukemia In Combination With Chemotherapy
Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved MYLOTARG™ (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL). MYLOTARG is the first and only AML therapy approved in the European Union (EU) that targets CD33, an antigen expressed on AML cells in up to 90% of patients.1,2,3
Apr 19, 2018 12:38 pm ET
Pfizer Invites Public to Listen to Webcast of April 26 Annual Meeting of Shareholders
Pfizer Inc. invites investors and the general public to listen to a webcast of the Annual Meeting of Shareholders at 9:00 a.m. (Eastern Daylight Time) on Thursday, April 26, 2018. To pre-register and access the live audio webcast, visit https://investors.pfizer.com/proxy and click on the “Annual Meeti
Apr 17, 2018 04:15 pm ET
A.M. Best Affirms Credit Ratings of Blue Whale Re Ltd.
A.M. Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a+” of Blue Whale Re Ltd. (Blue Whale) (Burlington, VT). The outlook of these Credit Ratings (ratings) is stable.
Apr 16, 2018 07:55 am ET
Report: Developing Opportunities within Amicus Therapeutics, Rite Aid, Navient, ProPetro Holding, Pfizer, and Sysco — Future Expectations, Projections Moving into 2018
NEW YORK, April 16, 2018 (GLOBE NEWSWIRE) -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Amicus Therapeutics, Inc. (NASDAQ:FOLD), Rite Aid...
Apr 12, 2018 08:00 am ET
Pfizer Doses First Patient Using Investigational Mini-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy
Pfizer Inc. has initiated a Phase 1b clinical trial for its mini-dystrophin gene therapy candidate, PF-06939926, in boys with Duchenne muscular dystrophy (DMD). The first boy received an infusion of the mini-dystrophin gene on March 22nd, administered under the supervision of principal investigator, Edward Smith, MD, Associate Professor of Pediatrics and Neurology at Duke University Medical Center. Screening and enrollment of patients is expected to continue at up to four clinical research sites in the United States. Early data from t
Apr 10, 2018 02:00 pm ET
Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery
Pfizer Inc. today announced that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating INLYTA® (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. No new s
Apr 10, 2018 08:30 am ET
Pfizer Signs Lease for the Spiral at Hudson Yards in Manhattan
Pfizer announced that it has signed a 20-year lease for The Spiral, an office tower being built by Tishman Speyer, at 66 Hudson Boulevard at Hudson Yards of Manhattan. As part of its 20-year lease agreement, Pfizer will relocate its global headquarters from 235 East 42nd Street to The Spiral where it will occupy 15 floors, and expects to begin moving colleagues there in 2022.
Apr 04, 2018 08:00 am ET
U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. The European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.
Apr 03, 2018 08:00 am ET
Pfizer and Allogene Therapeutics Enter into Asset Contribution Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio
Pfizer Inc. (NYSE:PFE) and Allogene Therapeutics, Inc. (Allogene) today announced that the two companies have entered into an asset contribution agreement for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer.
Mar 29, 2018 12:45 pm ET
Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy
Pfizer Inc. (NYSE:PFE) announced today that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months. The preliminary safety data showed that tafamidis was generally well tolerated in this population and no new safety signals were identified.
Mar 23, 2018 08:00 am ET
Pfizer Reports Top-Line Results from a Study of CHANTIX®/CHAMPIX® (varenicline) in Adolescent Smokers
Pfizer Inc. (NYSE:PFE) announced today results from a Phase 4 study evaluating the efficacy and safety of CHANTIX®/CHAMPIX® (varenicline) for smoking cessation in nicotine dependent adolescents 12-19 years of age. The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 for CHANTIX/CHAMPIX compared to placebo. The study is a regulatory post marketing commitment for CHANTIX/CHAMPIX in the U.S. and EU for adolescents 12-16 years and 12-17 years of age, respectively.
Mar 23, 2018 07:27 am ET
ViiV Healthcare Gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure a
Mar 20, 2018 10:00 am ET
Pfizer Invites Public To View And Listen To Webcast Of May 1 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, May 1, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2018 Performance Report, to be issued that morning.
Mar 19, 2018 04:15 pm ET
U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
NEW YORK and TOKYO, March 19, 2018 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC), based on data from the Phase 3 PROSPER trial. XTANDI is currently indicated for the tre...
Mar 19, 2018 04:15 pm ET
U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC), based on data from the Phase 3 PROSPER trial. XTANDI is currently indicated for
Mar 19, 2018 07:00 am ET
BioDuro Collaboration with Pfizer Inc. Leads to Creation of a Shelf-Stable Fluorosulfation Reagent
SAN DIEGO, March 19, 2018 /PRNewswire/ -- BioDuro LLC, a global life science research and development organization, announces the creation of AISF ([4-(Acetylamino)phenyl]-ImidodiSulfuryl diFluoride), a convenient, shelf-stable, crystalline reagent for the synthesis of fluorosulfates and sulfamoyl fluorides. AISF was developed through a research collaboration with Pfizer Inc. (NYSE: PFE)....
Mar 11, 2018 08:00 am ET
Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) will present findings today from a real-world dat
Mar 08, 2018 04:51 pm ET
Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on XELJANZ® (tofacitinib) for Moderately to Severely Active Ulcerative Colitis
Pfizer Inc. announced a positive outcome from today’s U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The GIDAC met to discuss Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Mar 07, 2018 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Andy Schmeltz, Global President, Oncology, and Chris Boshoff, Senior Vice President and Head, Immuno-Oncology, Early Development and Translational Oncology, at the Cowen and Company 38th Annual Healthcare Conference on Wednesday, March 14, 2018 at 10:40 a.m. Eastern Daylight Time.
Mar 05, 2018 03:00 pm ET
Dan R. Littman Elected to Pfizer’s Board of Directors
Pfizer Inc. today announced the election of Dr. Dan R. Littman to its Board of Directors. Dr. Littman, age 65, was also appointed to the Corporate Governance and Science and Technology Committees of Pfizer’s Board.
Mar 02, 2018 05:00 am ET
Neofluidics Announces Collaboration with Pfizer Inc.
SAN DIEGO, March 2, 2018 /PRNewswire/ -- Neofluidics, LLC, a microfluidics biotechnology company, announced today that it has entered into a collaboration with Pfizer Inc. (NYSE: PFE) that will attempt to create a first-of-its-kind microfluidics-based platform using Neofluidics' proprietary droplet capture technology to evaluate dynamic drug exposure-response relationships....
Feb 23, 2018 09:00 am ET
Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF®
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union (EU). MYLOTARG™ (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine has been granted a positive opinion for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute pr
Feb 23, 2018 08:30 am ET
Pfizer Announces Update on European Marketing Authorization Application for SUTENT® (sunitinib) in Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). The CHMP’s recommendation is not binding but will now be taken into consideration by the European Commission (EC). There is currently no approved adjuvant treatment option avai
Feb 23, 2018 08:00 am ET
Albert Bourla Elected to Pfizer’s Board of Directors
Pfizer Inc. today announced the election of Albert Bourla, DVM, Ph.D. to its Board of Directors, effective immediately.
Feb 14, 2018 08:30 am ET
Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis
Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JAD
Feb 12, 2018 08:00 am ET
U.S., EU and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK TKIs. The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applicatio
Feb 05, 2018 05:12 pm ET
Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. The median for the primary endpoint, metastasis-free survival (MFS), was 36.6 months for men
Feb 05, 2018 04:10 pm ET
Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer
TOKYO and NEW YORK, Feb. 5, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503), President and CEO: Yoshihiko Hatanaka, "Astellas," and Pfizer Inc. (NYSE: PFE) announced today results from the Phase 3 PROSPER trial in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. The median for the primary endpoint, metastasis-free survival (MFS), was 36.6 months for men who rece...
Jan 31, 2018 08:25 am ET
Investor Expectations to Drive Momentum within QCR, Bridge, Enterprise Financial Services, Hewlett Packard Enterprise, Pfizer, and The Finish Line — Discovering Underlying Factors of Influence
NEW YORK, Jan. 31, 2018 (GLOBE NEWSWIRE) -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of QCR Holdings, Inc. (NASDAQ:QCRH), Bridge Bancorp,...
Jan 30, 2018 08:31 am ET
Thinking about Investing in Apple, Amazon.com, Gilead Sciences, McDonald's or Pfizer?
CHICAGO, Jan. 30, 2018 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for AAPL, AMZN, GILD, MCD, and PFE....
Jan 30, 2018 06:45 am ET
PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2017 RESULTS
Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2017 and provided 2018 financial guidance.
Jan 24, 2018 08:30 am ET
Pfizer Announces Positive Top-Line Results For Potential Biosimilar To Rituxan®/MabThera®
Pfizer Inc. (NYSE:PFE) today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®1.
Jan 08, 2018 08:30 am ET
Pfizer Inc. Announces Expiration and Results of its Tender Offer for its 5.750 per cent. Notes due 2021 and Related Solicitation of Consents
Pfizer Inc. (NYSE:PFE) (“Pfizer”) today announced the expiration and results of its previously announced (i) offer to purchase for cash (the “Tender Offer”) any and all of its outstanding €2,000,000,000 5.750 per cent. Notes due 2021 (the “2021 Notes”) from holders thereof, and related (ii) solicitation of consents (“Consents”) to amend the 2021 Notes and the indenture pursuant to which the 2021 Notes were issued (the “Indenture”) to shorten the required notice in the case of an optional redemption by Pfizer to not less than seven days nor more
Jan 08, 2018 08:00 am ET
Pfizer Establishes New Partnering Model for Early-Stage Academic Research
Pfizer Inc. (NYSE:PFE) today announced the creation of the Innovative Target Exploration Network (ITEN), a new, early-stage partnering model that enables collaborative relationships with select academic institutions and principal investigators around the world, to identify research projects that have the potential to deliver novel therapeutic targets and mechanisms of action to underpin future drug discovery in core areas of interest to Pfizer.
Jan 04, 2018 07:00 am ET
Berkeley Lights Announces Research Collaboration and License Agreement with Pfizer
EMERYVILLE, Calif., Jan. 4, 2018 /PRNewswire/ -- Berkeley Lights, Inc. (BLI), a company dedicated to bringing to market transformational platforms for biopharmaceutical processes, announced today that it has entered into a research collaboration and license agreement with Pfizer Inc. (NYSE: PFE) focused on optimizing BLI's proprietary BeaconTM Optofluidic platform with the goal of helping to accelerate Pfizer's monoclonal antibody (mAb) discovery and gene editing workflows. ...
Jan 03, 2018 11:01 pm ET
Arvinas Announces Research Collaboration and License Agreement with Pfizer Inc. for the Discovery and Development of Protein Degradation Drug Candidates
NEW HAVEN, Conn., Jan. 4, 2018 /PRNewswire/ -- Arvinas LLC, a private biotechnology company focused on creating a new class of drugs based on protein degradation, announced today a research collaboration and license agreement with Pfizer Inc. (NYSE: PFE) for the discovery and development of drug candidates using Arvinas' proprietary PROTAC (PROteolysis TArgeting Chimeras) Platform, a novel technology used to create small molecule therapeutics aimed at degrading disease-causing cellular proteins....
Jan 03, 2018 06:31 am ET
Sangamo and Pfizer announce collaboration for development of zinc finger protein gene therapy for ALS
RICHMOND, Calif. and NEW YORK, Jan. 3, 2018 /PRNewswire/ -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO) and Pfizer Inc. (NYSE: PFE) today announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) linked to mutations of the C9ORF72 gene....
Dec 27, 2017 10:00 am ET
Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Mikael Dolsten, President, Worldwide Research and Development, at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 8:30 a.m. Pacific Standard Time.
Dec 22, 2017 07:00 am ET
FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATROTM (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets.
Dec 21, 2017 01:04 pm ET
FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma
Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] Javelin Renal clinical development program is ongoing, including Phase III first-line study DARMSTADT, Germany and NEW YORK, Dec. 21, 2017 /CNW/ - Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC...
Dec 21, 2017 06:35 am ET
Pfizer Inc. Announces Pricing and Early Results of its Tender Offer for its 5.750 per cent. Notes due 2021 and Related Solicitation of Consents
Pfizer Inc. (NYSE:PFE) (“Pfizer”) today announced the pricing terms and the early tender results of its previously announced (i) offer to purchase for cash (the “Tender Offer”) any and all of its outstanding €2,000,000,000 5.750 per cent. Notes due 2021 (the “2021 Notes”) from holders thereof, and related (ii) solicitation of consents (“Consents”) to amend the 2021 Notes and the indenture pursuant to which the 2021 Notes were issued (the “Indenture”) to shorten the required notice in the case of an optional redemption by Pfizer to not less than
Dec 19, 2017 04:11 pm ET
U.S. FDA Approves Pfizer’s BOSULIF® (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon
Dec 19, 2017 11:00 am ET
Pfizer Invites Public to View and Listen to Webcast of January 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. EST on Tuesday, January 30, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter 2017 Performance Report, to be issued that morning.