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 under
accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial. This represents the third FDA approval Pfizer has received for an
oncology treatment, including two lung cancer medicines, within two
months.
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Press Release Archive
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) reported financial results for third-quarter 2018
and narrowed certain 2018 financial guidance ranges.
NEW YORK--(BUSINESS WIRE)--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)
Inhibitor (PF-06835919, Phase 2), together with Novartis’s tropifexor, a
non-bile acid, Farnesoid X receptor (FXR) agonist.
NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--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
in pain, physical function and patient’s global assessment of their OA,
compared to placebo. These data were presented during a late-breaking
oral session at the 2018 American College of Rheumatology/Association of
Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in
Chicago.
Bain Capital, LP and Pfizer Inc. (NYSE: PFE) today announced the creation of Cerevel Therapeutics, LLC (“Cerevel”), a new biopharmaceutical company focused on developing drug candidates to treat disorders of the central nervous system (CNS).
NEW YORK--(BUSINESS WIRE)--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, although
this difference did not reach the prespecified threshold for statistical
significance (median OS: 34.9 months [95% CI: 28.8, 40.0] versus 28.0
months [95% CI: 23.6, 34.6]; HR=0.81 [95% CI: 0.64, 1.03], 1-sided
p=0.0429). These data will be presented as a late-breaking oral abstract
during the Presidential Symposium at the ESMO 2018 Congress (European
Society for Medical Oncology) in Munich, Germany, and simultaneously
published in The New England Journal of Medicine.
Pfizer Inc. today announced that the U.S. Food and Drug Administration approved TALZENNA® (talazoparib).
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.
Pfizer today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants totaling more than $3 million (USD) in funding will be awarded to investigators in the United States (U.S.) to support clinical research projects involving Pfizer compounds in breast cancer.
NEW YORK--(BUSINESS WIRE)--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.
NEW YORK--(BUSINESS WIRE)--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.
NEW YORK--(BUSINESS WIRE)--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.
NEW YORK--(BUSINESS WIRE)--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.
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.
NEW YORK--(BUSINESS WIRE)--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
ATTR-CM is a rare, fatal, and underdiagnosed condition associated with
progressive heart failure for which there are currently no approved
pharmacologic treatments.2
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/JAK1,
respectively) as measured by the Severity of Alopecia Tool (SALT) score
(100 point scale). The findings were presented during a Late-Breaking
News session at the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris, France.
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO® (avelumab) in combination with INLYTA® (axitinib), compared with SUTENT® (sunitinib) as initial therapy for patients with advanced renal cell carcinoma (RCC).
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.
NEW YORK--(BUSINESS WIRE)--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
Pfizer Inc. (NYSE: PFE) today announced the pricing of a debt offering consisting of six tranches of notes:
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Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.
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