Specialty Pharma Journal Specialty, Precision & Technology
LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced top line results from the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the …
Tag Archives: HER2
December, 2018
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6 December
Puma Biotechnology Presents Results from the HR-Positive Subgroup in Phase III Trial of Neratinib for HER2-Amplified, Early Stage Breast Cancer
LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from the subgroup of patients with hormone receptor positive (HR-positive) breast cancer from the Company’s Phase III ExteNET Trial of neratinib for early stage HER2-Amplified breast cancer are being presented at the 2018 San Antonio Breast Cancer …
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6 December
Genentech’s Kadcyla Cut the Risk of Disease Recurring by Half Compared to Herceptin in People With HER2-Positive Early Breast Cancer With Residual Disease
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50 percent …
November, 2018
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28 November
Daiichi Sankyo and Roche to Collaborate on New HER2 Low Companion Diagnostic Test
TOKYO and MUNICH and BASKING RIDGE, N.J., Nov. 27, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into an agreement with Roche to collaborate on the development of a new HER2 low companion diagnostic test. Under the terms of the agreement, Roche …
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28 November
BeiGene Acquires Rights to Zymeworks’ HER2-Targeted Candidates and Enters License Agreement for Zymeworks’ Azymetric and EFECT Platforms
VANCOUVER, Canada & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the two companies …
October, 2018
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15 October
Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin®(trastuzumab) …
August, 2018
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23 August
Novartis’ Investigational PI3K inhibitor Meets Primary Endpoint in Phase 3 Breast Cancer Trial
Basel, August 23, 2018 – Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with …
June, 2018
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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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18 June
Published Case Report Demonstrates the Clinical Utility of Biocept’s CTC Platform in Metastatic Breast Cancer
SAN DIEGO, June 18, 2018 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the publication of a peer-reviewed case report demonstrating the clinical utility of its …
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18 June
Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last …