1. Articles in category: Pharma

    1-14 of 14
    1. New cancer therapy study results - Magic Trial

      /PRNewswire/ -- NSHOA Cancer Center and Heron Therapeutics, Inc. (NASDAQ: HRTX) today announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company's 5-HT3 receptor antagonist product candidate SUSTOL® (granisetron injection, extended release) as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents. NSHOA Cancer Center had a major impact in the MAGIC study. , M.D., was chosen to be Principal Investigator ...

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    2. The European Commission Approves ALOXI® (palonosetron HCl) Injection to Prevent Nausea and Vomiting Due to Chemotherapy in Children as Young as One Month

      The European approval of ALOXI® for paediatric use follows the FDA approval in of ALOXI® for paediatric use in the US Helsinn Group, the Swiss Group focused on building quality cancer care, today announces that the European Commission has endorsed the Committee for Medicinal Products for Human Use's (CHMP) Opinion recommending the approval of ALOXI® (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in paediatric patients one month of age and older. This is the first European ...

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    3. Europe OKs First PD-Inhibitor, Nivolumab

      Nivolumab (Opdivo, Bristol-Myers Squibb Company) becomes the first programmed-death (PD) immune checkpoint inhibitor immunotherapy to be recommended for approval in Europe.

      The European Medicines Agency has recommended approval of the drug for use as first-line treatment and also for use in previously treated patients with advanced (unresectable or metastatic) melanoma.

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    4. FDA approves Unituxin for pediatric patients with high-risk neuroblastoma

      FDA approves Unituxin for pediatric patients with high-risk neuroblastoma

      The FDA today announced the approval of dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma, according to a press release from the drug’s manufacturer. Dinutuximab (Unituxin, United Therapeutics) is an antibody designed to bond to the surface of neuroblastoma cells and is approved as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for pediatric patients who achieved at least a partial response to prior first-line multi-agent, multimodality therapy.

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    5. MabVax Therapeutics Receives Orphan Drug Designation for Therapeutic Vaccine to Treat Childhood Cancer Neuroblastoma

      MabVax Therapeutics Receives Orphan Drug Designation for Therapeutic Vaccine to Treat Childhood Cancer Neuroblastoma

      SAN DIEGOSept. 25, 2014 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: TELKD), a clinical stage oncology drug development company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's vaccine intended for the treatment of the childhood cancer neuroblastoma.  In the U.S., the designation carries significant incentives for the development of drugs to treat rare and difficult diseases.  The Company is preparing to commence a Phase 2 clinical trial with the vaccine in 2015. MabVax's neuroblastoma vaccine is a bivalent vaccine that elicits an antibody response targeting the ...

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      Mentions: Vaccine MSKCC
    6. Kolltan Cancer Study Results for KTN3379, Targeting ErbB3, Support Evaluating Combinations with Targeted Therapies

      NEW HAVEN, Conn.--(BUSINESS WIRE)--Kolltan Pharmaceuticals, a privately held biopharmaceutical company focused on the discovery and development of novel antibody-based drugs targeting receptor tyrosine kinases (RTKs), today announced top-line results from the open-label, dose escalation monotherapy portion of its Phase 1 clinical trial program of KTN3379 in adult patients with advanced solid tumors. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB f

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      Mentions: Antibody
    7. Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101

      Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101
      SAN DIEGO--(BUSINESS WIRE)--July 21, 2014-- 

      Ignyta, Inc. (Nasdaq: RXDX), an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations.

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      Mentions: ALK ASCO
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