bayer-jj

Bayer and J&J wrap positive PhIII cardio study for Xarelto

February 8, 2017 Bayer and its part­ners at J&J, back in the fall of 2012, started a mas­sive study to see if the drug Xarelto (ri­varox­a­ban) could help pre­vent major car­dio­vas­cu­lar events like my­ocar­dial in­farc­tion, stroke, and death in high risk pa­tients with coro­nary artery dis­ease or pe­riph­eral artery dis­ease. Very recently, a lit­tle more … Continue reading Bayer and J&J wrap positive PhIII cardio study for Xarelto

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Amgen Announces the Efficacy of Repatha® (Evolocumab) for Reducing The Risk Of Cardiovascular Events

Feb. 2, 2017 Amgen has announced that the FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial evaluating whether Repatha® (evolocumab) minimizes the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) met its primary composite endpoint (cardiovascular death, non-fatal stroke, non-fatal myocardial infarction (MI), coronary revascularization or hospitalization for unstable angina) and … Continue reading Amgen Announces the Efficacy of Repatha® (Evolocumab) for Reducing The Risk Of Cardiovascular Events

astrazeneca

AstraZeneca expands opportunities for 1st-line lung cancer Immuno-Oncology program

17 January 2017 AstraZeneca has provided an update on its Immuno-Oncology (IO) late-stage clinical development program in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial. The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) … Continue reading AstraZeneca expands opportunities for 1st-line lung cancer Immuno-Oncology program

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Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for a Potential Biosimilar to Humira (adalimumab), PF-06410293

January 5, 2017 Pfizer Inc. has announced that the confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. This trial is evaluating the safety, efficacy, and immunogenicity of PF-06410293 compared to Humira (adalimumab), each taken in combination with methotrexate, in … Continue reading Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for a Potential Biosimilar to Humira (adalimumab), PF-06410293

Eisai

Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study

January 25, 2017 Eisai says that its can­cer drug Lenvima (lenva­tinib) hit the pri­mary end­point in a Phase III study for the treatment of liver can­cer, prov­ing non-in­fe­rior to Nex­avar. That suc­cess will set up reg­u­la­tory fil­ings in the US, Eu­rope and Asia, the com­pany adds. Liver can­cer is a par­tic­u­larly big prob­lem in China, where Eisai … Continue reading Eisai plots new drug applications in US, Europe and China after Lenvima scores in head-to-head liver cancer study

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Roche’s emicizumab for the Treatment of haemophilia A meets primary endpoint in phase III study

22 December 2016 Roche has announced that the primary endpoint has been met for the phase III HAVEN 1 study assessing emicizumab prophylaxis in people with haemophilia A and inhibitors to factor VIII. The study revealed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to … Continue reading Roche’s emicizumab for the Treatment of haemophilia A meets primary endpoint in phase III study

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ABOUND Data Explores Safety and Efficacy of ABRAXANE® for the Treatment of Patients with Lung Cancer

Dec 6, 2016 Celgene Corporation has announced interim results from the ABOUND clinical trial program evaluating the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with advanced non-small cell lung cancer (NSCLC). Interim data presented from the ABOUND trials during the IASLC 17th World Conference on Lung Cancer (WCLC) reinforces the benefit of ABRAXANE/carboplatin doublet … Continue reading ABOUND Data Explores Safety and Efficacy of ABRAXANE® for the Treatment of Patients with Lung Cancer

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Positive Results Found in the Use of ABRAXANE® as First-Line Treatment of Metastatic Triple Negative Breast Cancer

The results of Celgene’s randomized phase II tnAcity trial of ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) were presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in December 6-10, 2016. The trial found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) … Continue reading Positive Results Found in the Use of ABRAXANE® as First-Line Treatment of Metastatic Triple Negative Breast Cancer

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Top-Line Results of Solanezumab Phase 3 Clinical Trial Announced by Lilly

Nov. 23, 2016 Eli Lilly and Company has announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial. This is a phase 3 study of solanezumab in people with mild dementia due to Alzheimer's disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to … Continue reading Top-Line Results of Solanezumab Phase 3 Clinical Trial Announced by Lilly

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Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) from AbbVie Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease

Nov 15, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company has announced that 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) … Continue reading Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) from AbbVie Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease