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NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that results from three phase III studies evaluating the use of continuous REVLIMID(lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine.

11 May 2012

ICD therapy significantly reduces mortality in patients with moderate heart failure

St. Jude Medical, Inc., a global medical device company, today announced results of the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) 10-Year Follow-up Study at Heart Rhythm 2012, the Heart Rhythm Society's 33rd Annual Scientific Sessions in Boston. The study demonstrated implantable cardioverter defibrillator (ICD) therapy significantly reduces mortality for at least 11 years in patients with moderate heart failure (HF).

11 May 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

Sunovion announces results from LATUDA open-label study for schizophrenia

Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.

10 May 2012

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

Today Biogen Idec announced that U.S. and EU regulatory authorities have accepted the company's marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis.

10 May 2012

Lenalidomide improves overall survival for patients with multiple myeloma

Data from the first large U.S. study assessing the effectiveness of long-term "maintenance" therapy with lenalidomide for patients with multiple myeloma show that the drug significantly improves the time to progression and overall survival for patients with this often-deadly hematologic cancer.

10 May 2012

$Women with spine fractures can benefit from alendronate therapy$

Women with spine fractures can benefit from alendronate therapy

Continuing a popular but controversial treatment for osteoporosis could reduce spine fracture risk for a particular group of patients, but others could see little to no change if they discontinue it. Based on available evidence, a UCSF researcher reevaluated his 2006 finding from a randomized 10-year study of alendronate, a type of bisphosphonate - a class of drugs that prevent loss of bone mass.

10 May 2012

Orexigen reports net loss of $10.4 million for first quarter 2012

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the first quarter of 2012.

10 May 2012

Resverlogix completes RVX-208 Phase 2b trial on CVD

Resverlogix Corp. is pleased to announce that dosing in SUSTAIN, a Phase 2b clinical trial to assess lipid trends and safety of RVX-208, has been completed on schedule.

10 May 2012

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

Sildenafil may improve cardiac function in children, young adults with single ventricle defects

Sildenafil, also known as the erectile dysfunction drug Viagra, may give a boost to underdeveloped hearts in children and young adults with congenital heart defects. Researchers from The Children's Hospital of Philadelphia report that sildenafil significantly improved echocardiographic measures of heart function in children and young adult survivors of single ventricle heart disease palliation.

9 May 2012

Two studies suggest long-term value of Deplin in treating MDD

Two studies presented this week at the 164th Annual Meeting of the American Psychiatric Association suggest the long-term value of Deplin (L-methylfolate 15mg) in treating major depressive disorder (MDD) and describe subsets of patients who may benefit more robustly from this medical food.

9 May 2012

Certain males at higher risk of infection after receiving experimental HIV vaccine

A long-term follow-up analysis of participants in the Step Study, an international HIV-vaccine trial, has confirmed that certain subgroups of male study participants were at higher risk of becoming infected after receiving the experimental vaccine compared to those who received a placebo.

8 May 2012

New data from Acucela’s ACU-4429 Phase 2a trial on advanced dry AMD/geographic atrophy

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that the first patient data from the ACU-4429 program were presented during a poster session at The Association for Research in Vision and Ophthalmology (ARVO) 2012 Annual Meeting.

8 May 2012

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.

8 May 2012

Vertex reports interim data from VX-809 and KALYDECO combination Phase 2 study for cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today an interim analysis of data from an ongoing Phase 2 study of VX-809 and KALYDECO (ivacaftor) that showed significant improvements in lung function (FEV1) among adults with cystic fibrosis (CF) who have two copies.

7 May 2012

NovaDigm reports positive data from Phase 1 NDV-3 vaccine program

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the presentation of positive data for its NDV-3 vaccine program in a second Phase 1 study.

7 May 2012

Galleon GAL-021 safe and well-tolerated in Phase I respiratory depression clinical study

Galleon Pharmaceuticals, a leader in the development of novel medicines to treat breathing disorders, today announced that its investigational drug GAL-021 appeared to be safe and well-tolerated and demonstrated dose-proportional pharmacokinetic effects on respiration in a Phase I clinical study of 30 healthy adults.

7 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012

KYTHERA ATX-101-10-16 trial for submental fat meets primary endpoints

KYTHERA Biopharmaceuticals, Inc. today announced the presentation of initial trial results from Study ATX-101-10-16, the first of two pivotal European Phase III clinical trials with ATX-101, a facial injectable drug for the reduction of unwanted fat under the chin, or submental fat.

7 May 2012

Placebo News and Research

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

ICD therapy significantly reduces mortality in patients with moderate heart failure

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Sunovion announces results from LATUDA open-label study for schizophrenia

EU and U.S. regulatory authorities accept Biogen Idec’s BG-12 NDA for review

Lenalidomide improves overall survival for patients with multiple myeloma

Women with spine fractures can benefit from alendronate therapy

Orexigen reports net loss of $10.4 million for first quarter 2012

Resverlogix completes RVX-208 Phase 2b trial on CVD

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Sildenafil may improve cardiac function in children, young adults with single ventricle defects

Two studies suggest long-term value of Deplin in treating MDD

Certain males at higher risk of infection after receiving experimental HIV vaccine

New data from Acucela’s ACU-4429 Phase 2a trial on advanced dry AMD/geographic atrophy

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Vertex reports interim data from VX-809 and KALYDECO combination Phase 2 study for cystic fibrosis

NovaDigm reports positive data from Phase 1 NDV-3 vaccine program

Galleon GAL-021 safe and well-tolerated in Phase I respiratory depression clinical study

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

KYTHERA ATX-101-10-16 trial for submental fat meets primary endpoints

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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