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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 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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October 9, 2014
11:43 EDTGILDStocks with call strike movement; GILD EWZ
Gilead (GILD) February 120 call option implied volatility increased 3% to 38, MSCI Brazil Index (EWZ) February 58 call option implied volatility increased 3% to 38 according to IVolatility.
08:32 EDTMRKMerck HCV solutions becoming more credible, says Bernstein
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08:28 EDTGILD, ABBVGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
16:26 EDTGILDOn The Fly: Closing Wrap
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16:01 EDTGILDOptions Update; October 8, 2014
iPath S&P 500 VIX Short-Term Futures down 2.73 to 29.51. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX PBR AA CLF GILD according to Track Data.
15:49 EDTGILDAchillion, Gilead rise after late breaking abstract for AASLD posted
Shares of Achillion (ACHN) are higher after the company announced this morning that four abstracts have been accepted for presentation at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases. Among those four is a late breaker poster presentation providing updated results, including SVR12, from an ongoing Phase 2 proxy study evaluating Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus infection. Sofosbuvir is sold under the brand name Sovaldi by Gilead Sciences (GILD). In a note to investors, FBR Capital noted that the "surprise" late-breaking poster for the meeting showed a 100% cure rate for the combination therapy. In late afternoon trading, Achillion shares are up 10% to $10.74 while Gilead is up 4.3% to $108.78.
11:31 EDTRHHBYFDA grants priority review for Genentech's Lucentis
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7M Americans. The FDA confirmed action date is February 6, 2015. The sBLA was submitted August 7 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients. The submission is based on results of the RISE and RIDE Phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with Lucentis at two years compared to patients treated with sham injections. Benefits of Lucentis treatment were maintained during year three of treatment. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
11:14 EDTMRKMerck presents new MK-5172/MK-8742 clinical study data
Merck announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir, or MK-5172/MK-8742, are scheduled to be presented at the 65th American Association for the Study of Liver Diseases Annual Meeting, also known as The Liver Meeting. The meeting is scheduled to take place from November 7-11. New data will also be presented for MK-3682, formerly IDX21437, as part of its purchase of Idenix Pharmaceuticals.
11:08 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses IMPROVE-IT's regulatory and commercial implications for novel LDL-lowering therapies on an Analyst/Industry conference call to be held on October 9 at 2 pm.
10:55 EDTRHHBY, MRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:19 EDTRHHBYCBI to hold a conference
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07:18 EDTGILD, MRK, ABBV, BMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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