Efficacy News and Research

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Patients at high-risk for recurrent C. difficile with unnecessary antibiotic use

The impact of antibiotic misuse has far-reaching consequences in healthcare, including reduced efficacy of the drugs, increased prevalence of drug-resistant organisms, and increased risk of deadly infections. A new study featured in the February issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, found that many patients with Clostridium difficile infection (C. difficile) are prescribed unnecessary antibiotics, increasing their risk of recurrence of the deadly infection.

10 Jan 2013

Fingolimod could potentially eliminate or reduce progression of colitis-associated cancer

After uncovering a mechanism that promotes chronic intestinal inflammation and the development of colorectal cancer, scientists from Virginia Commonwealth University Massey Cancer Center have found that fingolimod, a drug currently approved for the treatment of multiple sclerosis, could potentially eliminate or reduce the progression of colitis-associated cancer (CAC).

10 Jan 2013

Concern regarding cefixime failure rate in gonorrhea patients

Results from a Canadian study add to those of prior studies suggesting that resistance of Neisseria gonorrhoeae to the cephalosporin antibiotic cefixime is increasing worldwide.

9 Jan 2013

CTI initiates enrollment in pacritinib Phase 3 trial for myelofibrosis

Cell Therapeutics, Inc. (CTI) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.

9 Jan 2013

Lilly, Boehringer Ingelheim announce top-line results from empagliflozin Phase III trials on T2D

Boehringer Ingelheim and Eli Lilly and Company today announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D).

9 Jan 2013

Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801.

9 Jan 2013

Psychologic treatment has long-term benefits for bipolar patients

Psychoeducation and cognitive behavioral therapy combined with pharmacologic treatment provides significant long-term benefits for patients with refractory bipolar disorder, researchers report.

8 Jan 2013

Contingency management benefits drug-dependent mental health patients

Contingency management significantly reduces stimulant drug use in dependent patients with serious mental illnesses, researchers report.

8 Jan 2013

Adolescents may lose hepatitis B virus protection despite vaccination as infants

New research reveals that a significant number of adolescents lose their protection from hepatitis B virus (HBV) infection, despite having received a complete vaccination series as infants. Results in the January 2013 issue of Hepatology, a journal published by Wiley on behalf of the American Association for the Study of Liver Diseases, suggest teens with high-risk mothers (those positive for HBeAg) and teens whose immune system fails to remember a previous viral exposure (immunological memory) are behind HBV reinfection.

8 Jan 2013

Esperion reports positive results from ETC-1002 Phase 2 clinical trial on type 2 diabetes

Esperion Therapeutics, the leading developer of small molecule therapies for the treatment of cardiometabolic disorders, today announced positive results of a recently completed Phase 2 clinical trial of ETC-1002 in patients with type 2 diabetes with LDL-C lowering of up to 43% compared to placebo.

8 Jan 2013

Thoratec to start REVIVE-IT study using HeartMate II Left Ventricular Assist System

Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that the U.S. Food and Drug Administration has granted an Investigational Device Exemption to commence the REVIVE-IT study utilizing the HeartMate II Left Ventricular Assist System.

8 Jan 2013

Repeated toxin treatment sustains benefits in incontinence patients

Repeated treatment with onabotulinumtoxinA consistently reduces urinary incontinence episodes in patients with neurogenic detrusor overactivity, show findings from an extension study of Phase III trials.

7 Jan 2013

Vaccine gives HIV patients a long-term boost

A functional cure for HIV-1 seems feasible after research shows that an immunotherapeutic vaccine demonstrated long-term efficacy at reducing viral load when administered to patients in the early stages of disease.

7 Jan 2013

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Our review included analyses of drug and device studies conducted in humans. The drugs or devices could be compared to placebo or sham treatments, or other effective treatments. The drugs and devices examined for this review are used for a wide variety of clinical conditions, including cardiovascular and psychiatric diseases.

7 Jan 2013

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

Edison Pharmaceuticals today announced the initiation of a phase 2B study entitled, "Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia."

7 Jan 2013

Biogen Idec files rFIXFc BLA with FDA for treatment of hemophilia B

Today Biogen Idec announced the company recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B.

7 Jan 2013

PharmaIN receives FDA orphan-drug designation for terlipressin to treat ascites

PharmaIN Corporation and LAT Pharma LLC today announced that the US Food and Drug Administration (FDA) has granted their request for orphan-drug designation for terlipressin for the treatment of ascites due to all etiologies except for cancer.

7 Jan 2013

Training can improve inpatient record documentation

The accuracy and completeness of inpatient medical records can be significantly improved with clinical interventions designed to develop quality record keeping, research shows.

4 Jan 2013

Psychologic treatment has long-term benefits for bipolar patients

Psychoeducation and cognitive behavioral therapy combined with pharmacologic treatment provides significant long-term benefits for patients with refractory bipolar disorder, researchers report.

4 Jan 2013

PSCA gene’s rs2294008 variant on T nucleotide may increase risk of bladder cancer

Patients who have inherited a specific common genetic variant develop bladder cancer tumors that strongly express a protein known as prostate stem cell antigen (PSCA), which is also expressed in many pancreatic and prostate tumors, according to research at the National Institutes of Health.

4 Jan 2013

Efficacy News and Research

Patients at high-risk for recurrent C. difficile with unnecessary antibiotic use

Fingolimod could potentially eliminate or reduce progression of colitis-associated cancer

Concern regarding cefixime failure rate in gonorrhea patients

CTI initiates enrollment in pacritinib Phase 3 trial for myelofibrosis

Lilly, Boehringer Ingelheim announce top-line results from empagliflozin Phase III trials on T2D

Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes

Psychologic treatment has long-term benefits for bipolar patients

Contingency management benefits drug-dependent mental health patients

Adolescents may lose hepatitis B virus protection despite vaccination as infants

Esperion reports positive results from ETC-1002 Phase 2 clinical trial on type 2 diabetes

Thoratec to start REVIVE-IT study using HeartMate II Left Ventricular Assist System

Repeated toxin treatment sustains benefits in incontinence patients

Vaccine gives HIV patients a long-term boost

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

Biogen Idec files rFIXFc BLA with FDA for treatment of hemophilia B

PharmaIN receives FDA orphan-drug designation for terlipressin to treat ascites

Training can improve inpatient record documentation

Psychologic treatment has long-term benefits for bipolar patients

PSCA gene’s rs2294008 variant on T nucleotide may increase risk of bladder cancer

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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