Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: pfizer
September, 2018
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21 September
FDA Grants Breakthrough Therapy Designation to Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia
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 …
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19 September
Pfizer Presents New Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy Study
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 …
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19 September
Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the EADV Congress
NEW YORK–(BUSINESS WIRE)–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 …
August, 2018
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30 August
After Phase 2 Failure, Pfizer Terminates Domagrozumab Program for Treatment of Duchenne Muscular Dystrophy
NEW YORK–(BUSINESS WIRE)–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 …
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23 August
Pfizer and Astellas Amend Clinical Research Protocols to Accelerate Completion Dates for Phase 3 Trials of Enzalutamide in Prostate Cancer
NEW YORK & TOKYO–(BUSINESS WIRE)–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). …
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22 August
Pfizer and Exact Sciences Enter Agreement to Co-Promote Colorectal Cancer Screening Test 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 …
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16 August
BioNTech Enters Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza
MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of …
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9 August
Sangamo Announces Positive Preliminary Data from the Phase 1/2 Study Evaluating SB-525 Gene Therapy for Hemophilia A
RICHMOND, Calif., Aug. 8, 2018 /PRNewswire/ — Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced positive preliminary data from the Phase 1/2 clinical trial evaluating SB-525, a cDNA gene therapy candidate for Hemophilia A (the “Alta study”). SB-525 is being developed as part of a global collaboration between Sangamo and Pfizer …
July, 2018
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23 July
FDA Approves Pfizer’s Nivestym, a Biosimilar to Neupogen (filgrastim)
NEW YORK–(BUSINESS WIRE)–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. “The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options …