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: breast cancer
December, 2018
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6 December
Novartis’ Investigational BYL719 plus Fulvestrant Improved PFS in Patients with PIK3CA Mutated HR+/HER2- Advanced Breast Cancer
Basel, December 6, 2018 – Novartis today announced additional analysis from the global Phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 (alpelisib) in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. In …
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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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14 November
FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for PD-L1-Positive Metastatic TNBC
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of …
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9 November
SELLAS Life Sciences Announces Additional Data Showing Consistent Clinical Effect Across HLA Allele Subgroups in Triple Negative Breast Cancer Patients Treated with Nelipepimut-S Plus Trastuzumab
NEW YORK, Nov. 09, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced data from a preplanned secondary efficacy analysis across human leukocyte antigen …
October, 2018
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24 October
SELLAS Announces Positive Final Data from Phase 2b Trial of NeuVax in Combination with Herceptin in Triple Negative Breast Cancer
NEW YORK, Oct. 22, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored …
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18 October
FDA Approves Pfizer’s Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for …
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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) …
September, 2018
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27 September
Hologic to Acquire Focal Therapeutics for $125 Million, Strengthening Breast Surgery Franchise
MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that it has signed a definitive agreement to acquire Focal Therapeutics, a privately-held company, for $125 million in cash. In conjunction with Hologic’s recent acquisition of Faxitron Bioptics, Focal strengthens the Company’s position in the rapidly …