Mon, Feb. 9, 9:12 AM
Thu, Jan. 8, 10:46 AM
Dec. 9, 2014, 12:38 PM
- RedHill Biopharma Ltd. (RDHL +12.2%) submits a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking approval for the 5-HT3 receptor Bekinda (ondansetron) (formerly RHB-102) for the treatment of cancer therapy-induced nausea and vomiting.
- The MAA has been submitted under the European Mutual Recognition Procedure with the UK as the reference European member state.
- The 5-HT3 market is estimated at ~$940M worldwide with Europe representing ~1/3 of the total.
- CINV-related tickers: (OTC:ESALF) (OTCPK:ESALY -3%) (OPK +1.1%)(GALE +1.8%)(INSY +0.7%)(HRTX +1.3%)(TSRO +2.9%)(GWPH +4.5%)
Nov. 24, 2014, 12:46 PM
Nov. 18, 2014, 1:34 PM
- Galena Biopharma (GALE +3.6%) completes the enrollment of 18 patients six months ahead of schedule in a Phase 2 proof-of-concept trial to assess the platelet lowering ability of GALE-401 (anagrelide controlled release) in patients with myeloproliferative neoplasms.
- The platelet lowering effect will be measured by the proportion of patients that achieve a complete or partial response for at least four weeks during the 24-week treatment cycle.
- GALE-401 is the company's new formulation of anagrelide. It releases its active ingredient more slowly over time than currently marketed versions of the drug.
Nov. 11, 2014, 12:04 PM
- Galena Biopharma (GALE +0.5%) reports that the first patient has been dosed in a new Phase 2 study evaluating NeuVax (nelipepimut-S) in combination with Roche's Herceptin (trastuzumab) for the prevention of breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified patients. Trial participants will be defined as 3+ by immunohistochemistry or gene amplified on the basis of being HER2 2+ and/or fluorescence in situ hybridization (FISH) >2.0.
- Patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + Herceptin or Herceptin + GM-CSF alone in the adjuvant setting following surgery.
- The primary endpoint in invasive disease-free survival. The company expects to complete the enrollment of 100 patients by 2H 2016. The follow-up period will be three years.
Nov. 3, 2014, 4:42 PM
- Galena Biopharma (GALE -6.8%) Q3 results ($M): Revenues: 1.6 (+38.5%); Costs and Expenses: 14.8 (+83.9%); Operating Loss: (13.2) (-91.6%); Net Loss: (6.2) (+33.5%); Loss Per Share: (0.05) (+54.5%); Quick Assets: 24.6 (-48.4%).
- NeuVax Phase 3 Present trial status: 533 of 700 patients treated.
- 2014 Guidance: Abstral revenue: $8M - 10M.
Nov. 3, 2014, 4:23 PM| 2 Comments
Nov. 2, 2014, 5:35 PM
- ACXM, AEIS, AGU, AIG, AMTG, ANV, APL, BDE, BKH, CHGG, CKP, CRK, CUTR, CVD, CXW, CYH, DXPE, EGAN, ELNK, ENH, EOX, EPAM, EQC, FN, FTR, GALE, GRT, GTY, HLF, IART, ININ, KAMN, KBR, LCI, MCEP, MDU, MR, MRO, NBIX, NLS, NOR, NTRI, OGS, OTTR, PKT, PL, PLOW, PQ, QLYS, RBC, REG, RKT, RKUS, RLD, RTEC, SALE, SBRA, SGY, SKH, SNHY, SRC, SSW, SUP, TDW, THC, TXRH, VNO, VNR, WTR, Y
Oct. 27, 2014, 12:29 PM
Oct. 14, 2014, 12:59 PM
- The Japanese Patent Office issues a notice of allowance to Galena Biopharma (GALE +5.7%) for its patent covering the use of NeuVax alone or in combination with other agents to prevent the recurrence of any HER2/neu-expressing breast cancer tumor having an immunohistochemistry level of 1+ or 2+ or a fluorescence in situ hybridization rating of less than about 2.0. Once issued, the patent will be in effect until 2027.
- Galena chief Mark W. Schwartz, Ph.D., says, "With this patent we now have coverage in the three largest potential breast cancer markets for NeuVax: the U.S., Europe and Japan."
Oct. 14, 2014, 9:15 AM
Oct. 10, 2014, 10:50 AM
- The FDA approves Akynzeo (netupitant and palonsetron) for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a combination of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting in the acute phase (24 hours) after the start of chemo. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (25 - 120 hours) after the start of chemo.
- Akynzeo is distributed in the U.S. by Eisai (OTC:ESALF)(OTCPK:ESALY -0.2%) under license from Lugano, Switzerland-based Helsinn Healthcare S.A.
- Related tickers: (OPK -1.6%)(GALE -6.1%)(INSY -1.9%)(HRTX -2.7%)(RDHL)(TSRO -0.8%)(GWPH -4.6%)
Sep. 26, 2014, 9:14 AM
Aug. 27, 2014, 12:46 PM
Aug. 26, 2014, 12:45 PM
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