Specialty Pharma Journal Specialty, Precision & Technology
NEW YORK–(BUSINESS WIRE)–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 …
Tag Archives: pfizer
April, 2018
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11 April
Pfizer Stops Late-Stage Trial in Renal Cell Carcinoma After it Fails to Demonstrate An Improvement in Disease-Free Survival
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 …
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5 April
FDA Grants Priority Review to Pfizer’s Dacomitinib for Treatment of Metastatic NSCLC
NEW YORK–(BUSINESS WIRE)–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 …
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5 April
Pfizer and Allogene Partner for Expedited Development of CAR T Immuno-Oncology Portfolio
NEW YORK & SOUTH SAN FRANCISCO–(BUSINESS WIRE)–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 …
January, 2018
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25 January
Pfizer Announces Positive Top-Line Results for Potential Biosimilar to Rituxan/MabThera
NEW YORK–(BUSINESS WIRE)–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. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of …
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18 January
Kite and Pfizer Collaborate to Evaluate Yescarta and Utomilumab in Large B-Cell Lymphoma
FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), announced it has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the investigational combination of Yescarta™ (axicabtagene ciloleucel) and Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in …
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3 January
Sangamo and Pfizer Collaborate for Development of Potential Gene Therapy for Treatment of 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) …
December, 2017
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22 December
FDA Approves Merck and Pfizer’s SGLT2 Drug for Treatment of Type 2 Diabetes
KENILWORTH, N.J. & NEW YORK–(BUSINESS WIRE)–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. …
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21 December
FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma
DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ — 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 Merck and …
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20 December
FDA Approves Pfizer’s Bosulif for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia
NEW YORK–(BUSINESS WIRE)–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 …