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News Breaks
May 15, 2014
07:14 EDTPCYC, RHHBY, ABBVAbbVie, Roche drug a real threat to Pharmacyclics, says Bernstein
After analyzing abstracts from the ASCO conference, Bernstein believes that ABT199, a treatment for CLL from Roche (RHHBY) and AbbVie (ABBV), is a "real threat" to Pharmacyclics' (PCYC) Imbruvica. However, the firm continues to believe that Imbruvica is impressive due to its duration of effect. It keeps an Outperform rating on Roche and a Market Perform rating on Pharmacyclics.
News For ABBV;RHHBY;PCYC From The Last 14 Days
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October 15, 2014
06:58 EDTABBVAbbVie volatility elevated into reconsidering Shire merger
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06:55 EDTABBVShire volatility elevated into AbbVie reconsidering merger recommendation
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06:16 EDTPCYCPharmacyclics initiated with a Buy at Citigroup
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05:34 EDTABBVShire says AbbVie should proceed with recommended offer
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October 14, 2014
19:59 EDTABBVAbbVie down nearly 2% after board reconsiders Shire merger
19:48 EDTABBVAbbVie board reconsidering recommendation to holders to accept Shire merger
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19:46 EDTABBVAbbVie board reconsidering recommendation to holders to accept Shire merger
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12:41 EDTABBVGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
11:23 EDTRHHBYBIND Therapeutics and The Conference Forum hold a conference
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10:51 EDTABBVGilead weakness a buying opportunity, says RBC Capital
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10:05 EDTABBVAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
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October 13, 2014
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.
08:05 EDTPCYCBristol-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.
07:39 EDTABBVPharmaceutical Care Management Association to hold annual meeting
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07:37 EDTABBVAmerican Society of Anesthesiologists to hold annual meeting
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October 9, 2014
08:28 EDTABBVGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
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.
10:55 EDTRHHBYLeerink 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.
07:19 EDTRHHBYCBI to hold a conference
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07:18 EDTABBVInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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