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News Breaks
July 25, 2014
07:17 EDTGILD, JNJEMA 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).
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October 14, 2014
08:58 EDTJNJJ&J sees FY14 operating sales on constant currency basis up 5.5%-6.5%
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07:50 EDTJNJJohnson & Johnson: Alios BioPharma transaction expected to close in Q4 of 2014
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07:50 EDTJNJJohnson & Johnson reports Q3 Worldwide Consumer sales down 0.6% to $3.6B
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07:49 EDTJNJJohnson & Johnson raises FY14 EPS to $5.92-$5.97 from $5.85-$5.92
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07:48 EDTJNJJohnson & Johnson reports Q3 domestic sales up 11.6% to $8.84B
Reports Q3 international sales down 0.3% to $9.63B. Worldwide, domestic and international operational sales growth, excluding the impact of this divestiture, was 8.4%; 14.8% and 3.1% respectively.
07:46 EDTJNJJohnson & Johnson reports Q3 adjusted EPS $1.50, consensus $1.44
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October 13, 2014
16:02 EDTGILDOptions Update; October 13, 2014
iPath S&P 500 VIX Short-Term Futures up 3.71 to 39.56. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX SUNE GILD BAC PBR according to Track Data.
15:24 EDTJNJNotable companies reporting before tomorrow's open
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14:24 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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14:15 EDTJNJEarnings Preview: Johnson & Johnson looks to new drugs to boost Q3 sales
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14:08 EDTJNJJohnson & Johnson technical notes before earnings
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09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
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08:40 EDTJNJAlios BioPharma reports positive results for AL-8176 in Phase 2 study
Alios BioPharma presented results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176 this past weekend at the IDWeek 2014 Conference in Philadelphia, PA. The study was conducted in healthy adult volunteers who were infected intranasally with respiratory syncytial virus, or RSV. AL-8176 achieved its primary and secondary endpoints of reduction in viral load and improvement in symptom scores as compared to placebo. AL-8176 was well tolerated with no discontinuations of study drug and no clinically significant laboratory abnormalities. In successfully infected subjects, a rapid and marked reduction in RSV viral load was observed following treatment in all three AL-8176 treated dose groups as compared to placebo. In contrast, successfully infected placebo subjects exhibited a logarithmic increase in RSV RNA with a peak viral load at Day 3.5 following start of dosing with placebo. The mean time to non-detectability of RSV RNA was 1.3-2.3 days for the AL-8176 treatment groups compared to 7.2 days in the placebo group. At discharge, all subjects treated with AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable upon follow-up on Days 16 and 28. The viral load reduction in infected subjects across all AL-8176 dosing regimens was associated with concomitant improvements in RSV symptom scores and reductions in mucus weight. On September 30, Johnson & Johnson announced a definitive agreement to acquire Alios.
08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
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08:05 EDTJNJBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:56 EDTGILDGilead Harvoni pricing 'very reasonable,' says RBC Capital
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07:39 EDTGILDPharmaceutical Care Management Association to hold annual meeting
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07:25 EDTJNJEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
07:15 EDTJNJNational Association of Corporate Directors to hold a conference
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07:13 EDTJNJBioFlorida to hold a conference
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