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News Breaks
July 25, 2014
07:17 EDTJNJ, GILDEMA recommends approval for Gilead, Janssen blood cancer drugs
The European Medicines Agency's Committee for Medicinal Products for Human Use, at its July meeting, recommended granting marketing authorizations for two new medicines with novel mechanisms of action for the treatment of different forms of rare cancers of the blood. Imbruvica and Zydelig are recommended for authorization in the treatment of adult patients with chronic lymphocytic leukemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy. Imbruvica, an orphan medicine, is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig is also to be used for adult patients with follicular lymphoma that has not responded to two previous treatments. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations. Once marketing authorisations have been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country. The marketing-authorization applicant for Imbruvica is Janssen-Cilag International (JNJ) and the marketing-authorization applicant for Zydelig is Gilead Sciences (GILD).
News For GILD;JNJ From The Last 14 Days
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July 28, 2015
16:03 EDTGILDGilead reports Q1 total product sales $8.1B
Total product sales for the second quarter of were $8.1B compared to $6.4B for the second quarter of 2014. Product sales in the U.S. were $5.6B compared to $4.8B for the second quarter of 2014. In Europe, product sales were $2B compared to $1.3B for the same period in 2014.
16:02 EDTGILDGilead raises FY15 net product sales view to $29B-$30B from $28B-$29B
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16:01 EDTGILDGilead reports Q2 adjusted EPS $3.15, consensus $2.71
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15:47 EDTGILDGilead July weekly 112 straddle priced for 6% movement
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15:21 EDTGILDNotable companies reporting after market close
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13:39 EDTGILDGilead technical notes before results
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11:42 EDTGILDStocks with call strike movement; FB GILD
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07:05 EDTJNJMacroGenics reports MGD011 advances into clinical development
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July 27, 2015
11:57 EDTGILDStocks with call strike movement; FB GILD
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10:40 EDTJNJLeerink major pharma analyst holds an analyst/industry conference call
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08:42 EDTGILDGilead July weekly volatility increases into Q2 and outlook
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05:56 EDTGILDStocks with implied volatility movement; CRM GILD
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July 24, 2015
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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July 23, 2015
17:51 EDTJNJJanssen submits sNDA to update label for Olysio
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12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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July 22, 2015
10:15 EDTJNJThoratec downgraded to Market Perform from Outperform at Northland
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
July 20, 2015
07:33 EDTGILDInternational AIDS Society to hold a conference
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July 17, 2015
10:21 EDTGILDCigna says 98.4% of customers treated with hep C drug Harvoni are cured
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09:03 EDTGILDGilead granted orphan status for gastric cancer treatment
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