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Stock Market & Financial Investment News

News Breaks
November 11, 2012
12:09 EDTVRTXVertex presents new Phase 3 data on HCV treatment with twice-daily telaprevir
Vertex Pharmaceuticals announced that new data from a Phase 3 study in people being treated for hepatitis C for the first time showed similar rates of viral cure (SVR12, HCV RNA levels < 25 IU/mL 12 weeks after the end of all treatment) when telaprevir was given twice daily compared to three times daily, the currently approved dosing schedule. Telaprevir is approved for use in combination with pegylated-interferon and ribavirin by the U.S. Food and Drug Administration, FDA, and Health Canada under the brand name INCIVEK® (telaprevir) tablets for people with genotype 1 chronic hepatitis C virus, HCV, with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). In addition, new data from a Phase 2 study demonstrated that approximately three of four people co-infected with HCV and HIV achieved an HCV viral cure (SVR24, HCV RNA levels < 25 IU/mL 24 weeks after the end of all treatment) with telaprevir combination treatment. These and other new data on Vertex’s medicines in development for hepatitis C were presented at The Liver Meeting®, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases, AASLD.
News For VRTX From The Last 14 Days
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May 21, 2015
11:04 EDTVRTXVertex has conference call hosted by JPMorgan
JPMorgan Analyst Kasimov hosts a conference call with CFO Ian Smith on May 26 at 1 pm.
10:30 EDTVRTXVertex management to meet with Maxim
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May 19, 2015
07:56 EDTVRTXGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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May 17, 2015
13:46 EDTVRTXVertex reports Orkambi data, says 'significant improvements' in primary endpoint
Vertex Pharmaceuticals announced that the New England Journal of Medicine published data from the two phase 3 studies of Orkambi, or lumacaftor/ivacaftor, a medicine designed to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. In November 2014, Vertex submitted an NDA to the FDA for the combination of lumacaftor and ivacaftor. On May 12th, the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 12-1 to recommend approval of Orkambi for people ages 12 and older with two copies of the F508del mutation. The FDA is expected to make a decision by July 5. The New England Journal reports that the studies enrolled 1108 patients who underwent randomization and received Orkambi. In both studies, there were significant improvements in the primary end point in both lumacaftor–ivacaftor dose groups. The difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV ranged 2.6%-4%, which corresponded to a mean relative treatment difference of 4.3 to 6.7%. Pooled analyses showed that the rate of pulmonary exacerbations was 30%-39% lower than in the placebo group. The rate of events leading to hospitalization or the use of intravenous antibiotics was also lower. The incidence of adverse events was generally similar to the placebo group.
May 15, 2015
09:31 EDTVRTXAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.

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