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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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September 9, 2014
09:34 EDTGILDGilead recently started cutting Sovaldi pricing by 8%, says Cleveland Research
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September 8, 2014
11:05 EDTGILDOptions with increasing implied volatility
Options with increasing implied volatility: NPSP GILD VNET AVNR GTAT YHOO RHT VRTX SDRL COV MYL
09:40 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL TWTR TSLA YHOO BAC FB MSFT NFLX GILD MCD
08:48 EDTGILDGilead announces AMBITION study results in collaboration with Glaxo
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September 5, 2014
16:45 EDTGILDMarket ends week little changed after mixed economic data
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12:57 EDTGILDOn The Fly: Midday Wrap
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12:04 EDTGILDGilead shares defended on today's weakness at Deutsche Bank
12:02 EDTGILDStocks with call strike movement; DAL GILD
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11:47 EDTGILDOptions with increasing implied volatility
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10:36 EDTGILDGilead volatility increases on wide price movement
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10:18 EDTGILDGilead shares defended at Bernstein
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10:11 EDTGILDGilead slips after VP discusses low-cost Sovaldi for 80 countries
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09:51 EDTGILDGilead drops, trades in wide range
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09:50 EDTGILDGilead down 3.5% after reports of potential generic Sovaldi deal coming
09:49 EDTGILDGilead near deal for generic Sovaldi for developing countries, Bloomberg reports
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09:43 EDTGILDGilead drops 6%, or $6.41, to $100.45
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09:35 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA YHOO WFM SLW ABX GOOG FB BIDU
September 4, 2014
11:30 EDTGILDStocks with call strike movement; AAL GILD
American Airlines (AAL) November 44 call option implied volatility increased 6% to 39, Gilead (GILD) November 130 call option implied volatility decreased 5% to 40 according to IVolatility.
09:35 EDTGILDActive equity options trading on open
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07:21 EDTGILDMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
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