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News Breaks
July 25, 2014
07:25 EDTGILDGilead receives positive opinion from CHMP for Zydelig
Gilead Sciences announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma, the most common subtype of indolent non-Hodgkin lymphoma. The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. The CHMP positive opinion for Zydelig is based on data from two clinical trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of Zydelig in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of Zydelig in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.
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November 17, 2014
09:36 EDTGILDActive equity options trading
Active equity options trading according to Track Data: AAPL PBR BHI GILD MU HD AMZN TSLA YHOO FB TWTR
November 14, 2014
14:53 EDTGILDCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
11:48 EDTGILDStocks with call strike movement; GILD BBY
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09:38 EDTGILDActive equity options trading
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November 13, 2014
13:32 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
November 12, 2014
07:53 EDTGILDLeerink to hold a tour
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November 11, 2014
16:14 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:01 EDTGILDOptions Update; November 11, 2014
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11:35 EDTGILDUBS holds a conference call with Gilead Sciences
UBS Biotech Analyst Roden, along with Dr. Bischofberger of Gilead Sciences, discuss the recently-held AASLD Meeting and the outlook of several GILD pipeline programs on a conference call to be held on November 13 at 4:30 pm.
08:07 EDTGILDGilead announces results from Phase 2 and 3 studies evaluating Harvoni
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08:05 EDTGILDGilead announces data from Phase 2 Sofosbuvir plus GS-5816 studies
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November 10, 2014
16:00 EDTGILDOptions Update; November 10, 2014
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09:35 EDTGILDActive equity options trading
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09:20 EDTGILDOn The Fly: Pre-market Movers
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08:48 EDTGILDGilead rises after Merck presents data on HCV combo
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07:20 EDTGILDGilead overhang from Merck HCV combo removed, says Wells Fargo
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November 7, 2014
09:36 EDTGILDActive equity options trading
Active equity options trading according to Track Data: AAPL WFM ABX GILD TSLA ZNGA FB FSLR GOOG AMZN
07:43 EDTGILDGilead Harvoni prescriptions trending well above Sovaldi, says RBC Capital
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