Specialty Pharma Journal Specialty, Precision & Technology
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free …
Tag Archives: chemotherapy
November, 2018
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2 November
FDA Approves Coherus’ Udenyca, a Biosimilar to Neulasta
REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved UDENYCA™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. UDENYCA™ …
July, 2018
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10 July
FDA Grants Eagle Seven Year Orphan Drug Exclusivity for Bendeka
WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute …
August, 2017
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25 August
Delivers Medicine to Cancer Cells While Protecting Healthy Cells
Cancer treatments, including chemotherapy, have helped many of those who have been diagnosed with the disease to go on to live healthy lives. Nevertheless, chemotherapy takes a toll on the body. During treatment, chemotherapy attacks all of the body’s cells, not just cancer cells. The result destroys healthy cells, causing …
July, 2017
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21 July
Concurrent Chemotherapy, Proton Therapy Improves Survival in Patients with Advanced Lung Cancer
HOUSTON – For patients with advanced, inoperable stage 3 lung cancer, concurrent chemotherapy and the specialized radiation treatment, proton therapy, offers improved survival compared to historical data for standard of care, according to a new study from The University of Texas MD Anderson Cancer Center. The research, published in JAMA Oncology, …
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5 July
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the use …
May, 2017
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26 May
FDA Panel Recommends Approval of Pfizer’s Epoetin Alfa Biosimilar Across All Indications
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA …
December, 2016
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14 December
Subtype of Triple Negative Breast Cancer Responds Better to Chemotherapy
Researchers at Yale Cancer Center have identified a new subtype of triple negative breast cancer that shows significantly improved response to chemotherapy. Patients with the newly defined subtype — BRCA-deficient triple negative breast cancer — had significantly higher survival rates with chemotherapy. The study was published on Dec. 13 in …
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6 December
FDA Expands Approval of Genentech’s Avastin for a Specific Type of Advanced Ovarian Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin®(bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the …
August, 2016
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26 August
More Chemo Drugs Don’t Improve Treatment of Rare Bone Cancer
Adding two chemotherapy drugs to the standard treatment for a rare bone cancer did not improve patients’ outcomes and increased toxic side effects, a study of more than 600 patients in 17 countries has found. The study, which was published Aug. 23 in The Lancet Oncology, provides the first head-to-head …