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News Breaks
May 21, 2014
11:09 EDTGILD, ABBV, BMY, MRKGilead sees new pushback over price of hepatitis C drug
An insurance trade group harshly criticized Gilead (GILD) for charging too much for its hepatits C drug, while Florida has reportedly restricted the ability of Medicaid recipients to receive the drug. WHAT'S NEW: The price that Gilead is charging for its HCV treatment Sovaldi is "astronomical," America's Health Insurance Plans stated on its blog yesterday. The drug has shown "tremendous results" and is the "kind of medical innovation we need to sustain," but the price is not sustainable for consumers or society and is the result of Gilead taking "advantage of a lack of competition," according to the group, which represents the health insurance industry. Meanwhile, Florida has restricted the ability of Medicaid patients in the state to access Sovaldi, Bank of America Merrill Lynch reported in a note to investors earlier today. The firm wrote that Florida's decision supports its thesis that payers will increasingly limit access to expensive drugs. WHAT'S NOTABLE: In late March, shares of Gilead fell after three Democratic members of the House Committee on Energy and Commerce said they were concerned about the price the company is charging for Sovaldi. In a letter to Gilead's CEO, the House members stated that reports have indicated that Gilead plans to charge $84,000 per treatment for Sovaldi and that they were concerned that the drug would not be able to cure patients if it cannot be afforded. Sovaldi's costs are likely to be too high for many patients, including those with both public and private insurance, the lawmakers contended, adding that the FDA's decision to speed the approval of Sovaldi makes the high price of the drug even more problematic. They requested that the company provide more information about its methodology for determining Sovaldi's prices and they sought information about any discounts the company is providing to low income patients. Other companies that are developing HCV drugs include AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Merck (MRK). PRICE ACTION: In mid-morning trading, Gilead rose 24c, or 0.3%, to $81.38. Over the last three months, Gilead shares are down about 1.5%.
News For GILD;ABBV;BMY;MRK From The Last 14 Days
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October 14, 2014
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 EDTABBV, MRKAmerican 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 EDTBMY, GILDMedivir 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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