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Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

NEJM publishes MSD's VICTRELIS two pivotal Phase III studies against HCV

MSD, known as Merck in the United States and Canada, announced today that final results from the two pivotal Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be published in the March 31st edition of The New England Journal of Medicine.

31 Mar 2011

Positive results from Meda's Dymista Phase III trial in patients with SAR

Meda announced today positive results from a Phase III clinical trial of Dymista, a novel formulation of azelastine hydrochloride and fluticasone propionate, in patients with seasonal allergic rhinitis.

22 Mar 2011

Bayer receives FDA approval for Gadavist Injection

Bayer HealthCare Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration has approved Gadavist Injection, a macrocyclic gadolinium-based contrast agent, for intravenous use in diagnostic magnetic resonance imaging in adults and children to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

14 Mar 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Celgene International Sàrl today announced that data from a randomised clinical study conducted by the Eastern Cooperative Oncology Group (ECOG) were presented at the 52nd Annual Meeting of the American Society of Hematology comparing REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) to lenalidomide plus high-dose dexamethasone (RD) in both younger and older newly-diagnosed multiple myeloma patients (NDMM).

7 Dec 2010

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

Merck's boceprevir improves SVR rate in adults with chronic hepatitis C virus genotype 1 infection

Merck reported today that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, demonstrated significantly higher sustained virologic response (SVR) rates in adult patients who previously failed treatment (treatment-failure; HCV RESPOND-2) and in adult patients who were new to treatment for chronic hepatitis C virus (HCV) genotype 1 compared to control, the primary objective of the studies.

1 Nov 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Astellas Pharma announces Phase IV study results of Lexiscan injection at ASNC session

Today Astellas Pharma US, Inc. announced results of a Phase IV study showing Lexiscan(regadenoson) Injection was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in subjects with asthma or chronic obstructive pulmonary disease (COPD) who are likely candidates for myocardial perfusion imaging (MPI) studies.

27 Sep 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

Sanofi-aventis receives FDA approval for new Taxotere Injection Concentrate formulation

Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

5 Aug 2010

Merck's two pivotal boceprevir Phase III registration studies for chronic HCV meet primary endpoint

Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.

5 Aug 2010

EMA CHMP recommends marketing approval of BRINAVESS for conversion of recent onset AF to sinus rhythm

Merck and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

28 Jun 2010

Genentech to present new data for targeted cancer medicines at 46th ASCO

Genentech, Inc., a wholly owned member of the Roche Group, today announced that it will present new data for its targeted cancer medicines and the way they may be used in several different cancer types at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Approximately 400 abstracts featuring Genentech and Roche's cancer medicines and investigational agents across 30 cancer types will be presented during the meeting that is taking place June 4 to 8, 2010 in Chicago.

21 May 2010

Phase 2 pivotal trial of AC220 initiated by Ambit Biosciences

Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML).

11 Dec 2009

Chantix new quit smoking drug approved

The U.S. Food and Drug Administration (FDA) has given approval for the sale of the first smoking cessation drug in almost ten years.

11 May 2006