Specialty Pharma Journal Specialty, Precision & Technology
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 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 …
Tag Archives: prostate cancer
December, 2018
October, 2018
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24 October
Bayer’s Darolutamide Meets Primary Endpoint in Phase 3 Trial in Patients with Non-Metastatic Castration-Resistant Prostate Cancer
WHIPPANY, N.J., Oct. 24, 2018 /PRNewswire/ — The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were …
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19 October
Clovis Oncology Presents Results from Ongoing Phase 2 Study Evaluating Rubraca in Metastatic Castration Resistant Prostate Cancer
BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced initial data from its ongoing Phase 2 TRITON2 clinical trial of Rubraca at the ESMO 2018 Congress (European Society for Medical Oncology). The data show a 44% confirmed objective response rate (ORR) by investigator assessment in 25 RECIST* /PCWG3** response-evaluable patients with a BRCA1/2 alteration. The median …
August, 2018
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30 August
Sophiris Bio Updates on Phase 2b Trial of Investigational Topsalysin in Prostate Cancer
SAN DIEGO and VANCOUVER, British Columbia, Aug. 29, 2018 /PRNewswire/ — Sophiris Bio Inc. (NASDAQ : SPHS ) (the “Company” or “Sophiris”), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced the conclusion of the …
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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). …
July, 2018
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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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5 June
Lynparza in Combination with Abiraterone Delayed Disease progression in Metastatic Castration-Resistant Prostate Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic …
January, 2018
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18 January
MDxHealth Develops Blood Test to Guide Precision-Treatment of Castration-Resistant Prostate Cancer Patients
HERSTAL, BELGIUM and IRVINE, CA, January 18, 2018 – MDxHealth SA (“MDxHealth, or the “Company”), (Euronext: Brussels MDXH.BR), an international healthcare company, developing and offering molecular diagnostic tests to personalize the diagnosis and treatment of urologic cancer, today announced promising research results with a new liquid biopsy test in development. Data from this …
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12 January
Immunomedics Enters Agreement with University of Wisconsin to Expand Sacituzumab Govitecan into Prostate Cancer
MORRIS PLAINS, N.J., Jan. 11, 2018 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced a collaboration with the Carbone Cancer Center at the University of Wisconsin, through Immunomedics entering an agreement with The Prostate Cancer Clinical Trials Consortium (PCCTC), to investigate Immunomedics’ lead antibody-drug conjugate (ADC) product candidate, …
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12 January
70% of Advanced Prostate Cancer Patients Treated with ProscaVax Demonstrate Improvements in PSA Doubling Time
BATON ROUGE, La., Jan. 10, 2018 (GLOBE NEWSWIRE) — OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, today announces the latest follow-up data from the Company’s Phase 1a trial of ProscaVax …