Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: pfizer
August, 2018
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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 …
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18 July
Pfizer and Lilly Announce Positive Top-Line Results from Late-Stage Trial of Tanezumab for Treatment of Osteoarthritis Pain
NEW YORK, & INDIANAPOLIS–(BUSINESS WIRE)–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 …
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17 July
FDA Approves Xtandi for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer
TOKYO & NEW YORK–(BUSINESS WIRE)–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 …
June, 2018
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27 June
FDA Grants Priority Review to Pfizer’s Glasdegib for Treatment of Patients with Previously Untreated Acute Myeloid Leukemia
NEW YORK–(BUSINESS WIRE)–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 …
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25 June
Pfizer’s Ibrance Misses Overall Survival Goal in Phase 3 Study in Metastatic Breast Cancer
NEW YORK–(BUSINESS WIRE)–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 …
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7 June
Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
NEW YORK–(BUSINESS WIRE)–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) …
May, 2018
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31 May
Pfizer’s Xeljanz Receives FDA Approval for Treatment of Moderately to Severely Active Ulcerative Colitis
NEW YORK–(BUSINESS WIRE)–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 …
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31 May
FDA Grants Breakthrough Therapy Designation to Pfizer’s Xalkori for Two New Indications
NEW YORK–(BUSINESS WIRE)–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 …