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April 9, 2014
49th Annual Meeting of EASL is being held in London, England on April 9-13.
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November 16, 2015
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:09 EDTJNJFDA approves Darzalex to treat multiple myeloma
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09:11 EDTENTAEnanta says ABT-493 study data show 'high sustained' response rates
Enanta Pharmaceuticals announced data from AbbVie's SURVEYOR studies of its investigational treatment regimen, consisting of ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment in non-cirrhotic patients with chronic hepatitis C virus infection. After 12 weeks of treatment, SVR12 rates achieved were 97%-100% in genotype 1 patients, 96-100 percent in genotype 2, and 83%-94% in genotype 3. These data will be presented at The Liver Meeting, which is the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco. Separately, in a late-breaking presentation of the SURVEYOR-1 trial, additional data will show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR rate of 97%.
09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
08:35 EDTMRKMerck to present Phase 2 hep C therapy data at The Liver Meeting
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07:24 EDTMRKSalomon to hold a conference
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07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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15:19 EDTMRKMerck reports integrated analysis of six trials of elbasvir/grazoprevir
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15:15 EDTMRKMerck reports Phase 3 data on elbasvir/grazoprevir in patients injecting drugs
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15:08 EDTICPTIntercept reports analysis of Phase 3 obeticholic acid study, other data
Intercept announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis, for presentation at the American Academy for the Study of Liver Diseases annual meeting. The studies evaluate investigational use of obeticholic acid, Intercept's lead farnesoid X receptor agonist. In a presentation titled, "Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase," an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody test showed that, of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that 69% of those likely PBC patients continued to have elevated ALP two years after the first positive AMA test. Meanwhile, a presentation titled "A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis" includes an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase, albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA plus or minus ursodiol or placebo plus or minus ursodiol at the end of the POISE study. The UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo. Lastly, a presentation titled "Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" showed that patients may not be properly informed about their ALP scores and the nature of PBC symptoms.
14:38 EDTICPTIntercept reports analyses of OCA in fatty liver patients
Intercept Pharmaceuticals announced new results from the non-invasive evaluation of liver fibrosis in patients from the FLINT trial of obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. In the trial, treatment with once daily 25 mg OCA was shown to reverse fibrosis in a "significant proportion" of biopsy-proven NASH patients, as observed by repeat liver biopsy at the end of the double-blind treatment phase at week 72, according to the company. Post-hoc analysis evaluated the early predictive value of three known non-invasive fibrosis tests -- FIB-4, APRI and NFS -- in identifying patients who experienced improvement in fibrosis. Each was assessed at baseline and over the course of treatment and then correlated with histologic changes observed in the OCA and placebo patients. The analysis demonstrated that OCA treatment of NASH patients led to a statistically significant decrease in FIB-4 from baseline as compared to placebo. Further, a decline in FIB-4 of 10% after 24 weeks of treatment predicted improvement in fibrosis by at least one stage as assessed by biopsy at 72 weeks, according to Intercept. Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo, and a 34% reduction in APRI at 24 weeks predicted improvement in fibrosis by at least one stage at 72 weeks. On average, OCA treatment reduced the FIB-4 score to less than 1.3 and the APRI score to less than 0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs. While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis, the company said.
14:30 EDTENTAEnanta confirms interim Phase 3b data on Viekira Pak
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November 13, 2015
15:35 EDTICPTIntercept to host investor meeting
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08:28 EDTENTA, ICPTAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
08:02 EDTMRKMerck: DMC recommends anacetrapib study continue with no changes
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November 12, 2015
17:55 EDTGILDGilead announces FDA approval of Harvoni
Gilead Sciences announced that the U.S. FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
17:02 EDTMRKMerck Animal Health to Acquire Harrisvaccines
Merck Animal Health and Harrisvaccines announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals. The terms of the agreement were not disclosed. The companies expect the transaction to close in the fourth quarter of 2015.
11:50 EDTMRKMerck issues statement regarding CUBICIN patent litigation
Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit: "The decision validated the patent for CUBICIN that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020. The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court."
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