Efficacy News and Research

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Uncertainty over efficacy of clopidogrel in hemolytic uremic syndrome

Clinical outcomes for children hospitalized with diarrhea-associated hemolytic uremic syndrome are comparable between those treated with clopidogrel and those who are not, show study findings.

12 Jun 2012

Pharmanest commences SHACT Phase II study in women

Today, Pharmanest AB announced that the first patient has been dosed in a randomized Phase II study of SHACT, a product developed for pain relief associated with intrauterine device (IUD) insertion. Karolinska Development AB (STO:KDEV) owns 58.9 percent of Pharmanest.

12 Jun 2012

Initial trial results from KYTHERA’s second of two Phase III trials with ATX-101

KYTHERA Biopharmaceuticals, Inc. today announced the presentation of initial trial results from Study ATX-101-10-17, the second of two pivotal European Phase III clinical trials with ATX-101, a facial injectable drug for the aesthetic treatment of submental fat, which commonly presents as an undesirable double chin.

12 Jun 2012

Genzyme files LEMTRADA sBLA and MAA with FDA, EMA for treatment of RMS

Genzyme, a Sanofi company, today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS).

12 Jun 2012

Investigational drug slows metastatic breast cancer progression

Trastuzumab emtansine significantly delays disease progression compared with standard therapy in women with human epidermal growth factor receptor-2-positive metastatic breast cancer, show study data presented at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, USA.

11 Jun 2012

HackensackUMC recognizes AcquiSci d-OSAB technology with research award

AcquiSci Inc., today announced it has received an award from the Hackensack University Medical Center to research AcquiSci's patented d-OSAB technology as a device-based approach to modulating inflammation.

11 Jun 2012

Positive results from Cara’s CR845 Phase II study on acute post-operative pain

Cara Therapeutics, Inc. today announced positive results from a Phase II study for the treatment of acute post-operative pain with its novel, peptide-based, peripherally-acting kappa opioid agonist, CR845.

11 Jun 2012

BioSante to initiate two new LibiGel Phase III efficacy trials in FSD, HSDD

BioSante Pharmaceuticals, Inc., announced today that the Company plans to initiate two new LibiGel Phase III efficacy trials. This decision is based on an extensive analysis of previous efficacy data, consultation with key opinion leaders (KOLs) in female sexual dysfunction, testosterone therapy and placebo effects, as well as a meeting with the U.S. Food and Drug Administration (FDA).

11 Jun 2012

Ampio’s CRO completes Optina clinical trial for DME

Ampio Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.

11 Jun 2012

Nanocontainers can fight against atherosclerosis

In Switzerland, more than 20,000 people (37% of all deaths) die of cardiovascular disease caused by atherosclerosis each year. Treatment options are currently available to people who suffer from the disease but no drug can target solely the diseased areas, often leading to generalized side effects.

11 Jun 2012

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a Phase 3 clinical study that showed the investigational compound dapagliflozin 10 mg demonstrated significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with type 2 diabetes.

11 Jun 2012

Zafgen announces new data from two Phase 1 studies of beloranib on obesity

Zafgen, Inc., the world's first biopharmaceutical company dedicated to addressing the unmet need of severely obese patients, today announced new data from two Phase 1 studies of beloranib, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed significant weight loss and improvements in cardiometabolic risk markers in severely obese women.

11 Jun 2012

Sanofi’s Lantus more effective than sitagliptin for people with type 2 diabetes

Sanofi announced today that people with early type 2 diabetes uncontrolled on metformin demonstrated superior HbA1c - glycated hemoglobin - reduction with Lantus (insulin glargine [rDNA origin] injection) versus sitagliptin.

11 Jun 2012

Cebix announces data from Ersatta Phase 1 study on type 1 diabetes

Cebix Incorporated today announced that data from a Phase 1 study demonstrated that Ersatta, the company's long-acting form of C-peptide, was well tolerated with no serious adverse events in patients with type 1 diabetes and exhibited a pharmacokinetic profile consistent with once-weekly dosing.

11 Jun 2012

JCAD publishes results from clincal study of Tria Skin Perfecting Blue Light for acne

The Journal of Clinical and Aesthetic Dermatology (JCAD), a respected peer-reviewed dermatology publication, has, in its May 2012 issue, published the results of a single-center study of the Tria Skin Perfecting Blue Light for acne, showcasing the overall effectiveness of the device in significantly reducing the amount of acne, as well as the frequency, severity and redness of acne flares.

10 Jun 2012

Positive results from Amgen Sensipar/Mimpara Phase 3 trial for HPT, CKD

Amgen today announced top-line results of the Phase 3 EVOLVE (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated Sensipar/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis.

8 Jun 2012

Accuray announces outcome data from CyberKnife Prostate SBRT study

Accuray Incorporated, the premier radiation oncology company, announced today that outcome data on intermediate risk prostate cancer patients treated with CyberKnife Prostate SBRT was presented at the American Urological Association Meeting (AUA) 2012 held in Atlanta, Ga.

8 Jun 2012

WHO identifies best targets for seasonal malaria treatment

"Pre-emptive treatment of children living in regions where malaria is prevalent only during the rainy season could avert 11 million cases and 50,000 deaths a year," the journal Nature reports, adding, "The estimates are based on the world's first guidance on seasonal malaria chemoprevention, issued by the World Health Organization (WHO) in March."

8 Jun 2012

Data from abatacept versus adalimumab Phase IIIb comparison study on RA

Data from one of the few head-to-head trials in rheumatoid arthritis (RA) presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, demonstrates that at one year, 64.8% of patients receiving abatacept (Orencia) and 63.4% of patients receiving adalimumab (Humira) achieved ACR20.

8 Jun 2012

NCI presents long-term outcomes from BiovaxID lymphoma vaccine Phase II trial at ASCO 2012

Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., today announced that the U.S. National Cancer Institute (NCI) presented long-term (median 10-year follow-up) outcomes at the 2012 American Society of Clinical Oncology Annual Meeting (ASCO 2012) from a Phase II BiovaxID lymphoma vaccine clinical trial.

8 Jun 2012