Posts by: Alice Melão

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Eagle Pharmaceuticals is preparing a pilot study that may pave the way for a pivotal clinical trial evaluating its new formulation of fulvestrant as a treatment for estrogen receptor (ER)-positive ... Read more

August 5, 2019September 10, 2019

First Generic Version of Navelbine Launched in Europe for Breast, Lung Cancers

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Lotus Pharmaceuticals has launched the first generic version of Pierre Fabre’s Navelbine (vinorelbine) in soft capsule form in Europe for the treatment of advanced breast cancer and advanced non-small-cell ... Read more

June 17, 2019

FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer

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The U.S. Food and Drug Administration (FDA) has approved Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Genentech’s Herceptin (trastuzumab), for all indications of its reference product — including as a ... Read more

March 20, 2019

CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers

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The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of advanced ... Read more

February 6, 2019

Knight Therapeutics Acquires Exclusive Marketing Rights to Nerlynx in Canada

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Breast cancer treatment Nerlynx (neratinib) will be exclusively commercialized in Canada by Knight Therapeutics, under an agreement with the therapy’s developer, Puma Biotechnology. Nerlynx is currently being reviewed by Health Canada as ... Read more

January 25, 2019

FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer

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The U.S. Food and Drug Administration (FDA) has rejected Immunomedics’ application for accelerated approval of sacituzumab govitecan as third-line treatment for advanced triple-negative breast cancer (TNBC), the company announced. ... Read more

January 21, 2019

Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

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The Phase 3 trial assessing Athenex‘s Oraxol — an oral formulation of the chemotherapy paclitaxel — for the treatment of advanced breast cancer has completed its planned patient enrollment. The progression ... Read more

January 9, 2019

FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer

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Generex Biotechnology is planning a Phase 2 trial to test a combination of its AE37 peptide vaccine and Keytruda (pembrolizumab) in patients with advanced triple-negative breast cancer, after the U.S. Food and Drug ... Read more

January 4, 2019

Phase 3 Trial of Sacituzumab Govitecan Recruiting Triple-negative Breast Cancer Patients

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A Phase 3 trial is recruiting participants to examine the effects of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC) who failed to respond, or relapsed after at least ... Read more

January 2, 2019

Posts by: Alice Melão

Alice Melão

Eagle Prepares Clinical Trials of New Form of Fulvestrant to Treat ER-positive Breast Cancer

First Generic Version of Navelbine Launched in Europe for Breast, Lung Cancers

FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer

CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers

Knight Therapeutics Acquires Exclusive Marketing Rights to Nerlynx in Canada

FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer

Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer

Phase 3 Trial of Sacituzumab Govitecan Recruiting Triple-negative Breast Cancer Patients

Top 10 Breast Cancer Articles of 2018

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