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News Breaks
February 8, 2013
15:37 EDTCELG, ONXXFDA announces approval of Celgene multiple myeloma treatment
The FDA said it approved Celgene's (CELG) Pomalyst to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. In July 2012, the FDA approved Kyprolis to treat multiple myeloma. The FDA said that similar to Onyx Pharmaceuticals' (ONXX) Kyprolis, Pomalyst is being approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use. The therapy was also granted orphan product designation because it is intended to treat a rare disease or condition. Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots. Because of Pomalyst’s embryo-fetal risk, it is available only through the Pomalyst Risk Evaluation and Mitigation Strategy Program.
News For CELG;ONXX From The Last 14 Days
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September 2, 2014
09:41 EDTCELGActive equity options trading on open
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08:19 EDTCELGCelgene GED301 drug has positive risk/reward ratio in near-term, says Bernstein
Bernstein believes that the upcoming trial of Celgene's GED0301 drug for Crohn's disease has very little risk in the near-term, while the presentation of results of a study of the drug next month should be positive for the stock. The firm thinks that the drug could emerge as a popular combination partner for other systemic drugs in patients who continue to have disease symptoms. Bernstein is more cautious about the drug's outlook starting in 2016 but keeps a $103 price target and Outperform rating on the stock.
August 31, 2014
13:41 EDTCELGCitigroup to hold a conference
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August 26, 2014
11:20 EDTCELGCelgene added to short term buy list at Deutsche Bank
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09:35 EDTCELGActive equity options trading on open
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08:04 EDTONXXOnyx treatment of Waldenstrom's macroglobulinemia granted orphan status
Oprozomib was granted FDA orphan drug designation as a treatment of Waldenstrom's macroglobulinemia, the agency stated. Reference Link
August 25, 2014
12:19 EDTCELGOn The Fly: Midday Wrap
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10:40 EDTCELGBiotechs rise after InterMune acquired by Roche
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August 20, 2014
08:02 EDTCELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 19, 2014
09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.”

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