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News Breaks
July 21, 2014
06:43 EDTGILD, RHHBY, MRK, ABBV, BMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
Several companies, including Roche (RHHBY) and Merck (MRK) have taken aggressive legal steps to claim that Gilead's (GILD) Sovaldi infringes upon their patents or contract rights and deserve a cut of the sales, reports the Wall Street Journal. Abbvi (ABBV), meanwhile, has obtained U.S. patents covering combinations of dozens of drugs to treat hepatitis-C as it develops a treatment of its own. Abbvie, Merck and Bristol-Myers Squibb (BMY) are also planning to bring their own regimens to market to compete with Gilead's. Reference Link
News For GILD;RHHBY;MRK;ABBV;BMY From The Last 14 Days
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October 14, 2014
10:11 EDTGILDGilead volatility increases on wide price movement
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10:05 EDTGILD, ABBVAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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09:37 EDTGILDActive equity options trading on open
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09:14 EDTGILDJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
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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.
09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
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09:23 EDTABBVAbbVie's Humira for hidradenitis suppurativa meets Phase 3 trial endpoint
AbbVie announced new results from PIONEER II, a pivotal Phase 3 study, demonstrating the effect of Humira in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa, specifically the number of abscesses and inflammatory nodules. The results of this study, in combination with previously presented results from PIONEER I, will contribute to worldwide regulatory filings for an expanded use of Humira, which is not currently approved by regulatory authorities for the treatment of HS.
08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
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08:05 EDTBMYBristol-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 EDTGILD, ABBVPharmaceutical Care Management Association to hold annual meeting
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07:37 EDTMRK, ABBVAmerican Society of Anesthesiologists to hold annual meeting
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07:13 EDTBMYBioFlorida to hold a conference
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October 10, 2014
14:08 EDTGILDGilead 12-week regimen of Harvoni to cost $94.5K
Gilead said its newly-approved treatment of hepatitis C genotype 1 infection, Harvoni, will be priced at $94,500 for a full 12 week regiment, according to multiple media outlets, which cite a company spokesperson.
13:55 EDTGILDGilead confirms FDA approval of Harvoni
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13:42 EDTGILDGilead hepatitis C treatment Harvoni approved by FDA
The FDA announced the approval of Harvoni to treat chronic hepatitis C virus genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection, the agency stated. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, it added. Harvoni is marketed by Gilead.
13:40 EDTGILDFDA approves Gilead hepatitus C treatment Harvoni
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10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:19 EDTGILD, BMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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07:21 EDTGILDFDA PDUFA Date for Gilead Sciences Sofosbuvir is October 10, 2014
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