Fri, Nov. 20, 9:52 AM
- With the aim of focusing on its clinical development programs, Galena Biopharma (GALE -3.4%) sells its Abstral (fentanyl) Sublingual Tablet business to privately held Sentynl Therapeutics for up to $12M, $8M upfront and $4M contingent on the achievement of certain milestones.
- Galena acquired the U.S. rights to Abstral from Swedish drug maker Orexo AB in March 2013. The FDA approved the pain medication in January 2011.
- Previously: Galena Biopharma (GALE +3.4%) gains after saying its entered into an agreement with Swedish drug... (March 18, 2013)
Thu, Nov. 12, 9:17 AM
Tue, Nov. 10, 10:22 AM
Tue, Nov. 10, 9:13 AM
Mon, Nov. 9, 4:16 PM
Sun, Nov. 8, 5:35 PM
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Fri, Oct. 30, 10:42 AM
Mon, Sep. 28, 9:13 AM
Wed, Sep. 2, 10:33 AM
- The FDA approves Tesaro's (TSRO +4.4%) VARUBI (rolapitant), in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with chemotherapy (CINV) in adult patients. Up to 50% of chemo patients experience delayed CINV (25 - 125 hours after treatment) even when taking a 5-HT3 receptor antagonist (Novartis' Zofran, formerly Glaxo's) and a corticosteroid.
- VARUBI, the company's first approved product, is an antagonist of human substance P/neurokinin 1 (NK-1) receptors with a plasma half-life of ~seven days. Phase 3 results showed a significant reduction in CINV or use of rescue medication when patients were administered a 180 mg dose one - two hours prior to chemo in combination with a 5-HT3 antagonist and dexamethasone.
- Related tickers: (NVS -0.1%)(HRTX +0.2%)(OPK +1%)(INSY +2.7%)(RDHL +1%) (OTC:ESALF) (OTCPK:ESALY) (GALE +0.6%)(GWPH +1.1%)(MRK -0.1%)
Thu, Aug. 6, 4:20 PM
Wed, Aug. 5, 5:35 PM
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Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Wed, Jul. 29, 9:53 AM
- Galena Biopharma (GALE +5%) announces the U.S. launch of Zuplenz (ondansetron) Oral Soluble Film in 4 mg and 8 mg strengths. It is indicated for prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting and post-operative nausea and vomiting in adult patients. It is also cleared for moderately emetogenic CINV in pediatric patients at least four years old.
- Zuplenz, based on an oral soluble film technology called PharmFilm, dissolves in the mouth in about 10 seconds. It does not require water to administer and enables the patient to avoid the burden of swallowing a pill.
Mon, Jun. 15, 12:41 PM
- Interim data from a Phase 2 trial assessing Galena Biopharma's (GALE) anagrelide controlled release (GALE-401) in patients with thrombocytosis secondary to essential thrombocythemia (ET) and other myeloproliferative neoplasms (MPNs) show encouraging efficacy. The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
- The overall response rate in the 18-subject study was 78% (n=14/18) and complete and partial response rates were both 39% (n=7/18). The median time to response was five weeks (range: 3-10) while the median duration of response had not been reached by the data cutoff.
- Thrombocytosis is a disorder in which the body produces too many platelets.
- The immediate release formulation of anagrelide, Agrylin, was approved in 1997 for the indication.
- Final data from the trial will be presented at the American Society of Hematology meeting in December.
Mon, Jun. 8, 9:16 AM
Wed, May 27, 1:19 PM
- Galena Biopharma (GALE +12%) heads north on a 4x surge in volume in apparent response to the publication of two abstracts at ASCO.
- The first, Abstract #e14031, is a summary of results from a 51-subject Phase 1/2a dose-ranging study of GALE-301 (folate binding protein), a peptide immunotherapy given as an adjuvant treatment to prevent recurrences in high-risk ovarian and endometrial cancer patients. With almost 10 months median followup, the 1000 mcg dose group showed only one clinical recurrence compared to 11 in the control group. The estimate for disease-free survival at two years is 85.7% for the 1000 mcg cohort versus 19.2% for control but the results are not statistically significant (p=0.09). Combining the low dose group (<1000 mcg) dropped the complete response rate to 38% versus 50% for control although, again, the results lacked statistical validity (p=0.41). These data were presented in November at the Society for Immunotherapy of Cancer meeting in Maryland.
- The second, Abstract #e11609, is a summary of data supporting the use of the BOND Oracle HER2 IHC System for identifying low-to-medium HER2-expressing breast cancer patients that would be candidates to receive NeuVax (nelipepimut-S).
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