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ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Valsartan delays progression to type 2 diabetes in IGT patients: NAVIGATOR study

Results from a landmark study involving more than 9,000 people showed that the high blood pressure medicine valsartan delayed progression to type 2 diabetes in patients with cardiovascular disease or risk factors and impaired glucose tolerance (IGT), a common pre-diabetic condition.

15 Mar 2010

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

Bristol-Myers Squibb, AstraZeneca commence SAVOR-TIMI 53 trial of ONGLYZA for type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced the commencement of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” trial, a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors.

10 Mar 2010

Tracking kidney number is just as important as controlling cholesterol, say DNA physicians

It's a silent epidemic that affects millions of Americans. Chronic Kidney Disease (CKD) is a life-threatening illness that can often be treated successfully if found early, and can be detected at an early stage using simple, inexpensive blood and urine tests. As part of its 2010 World Kidney Day awareness program, the physicians of Dallas Nephrology Associates urge everyone to know and track their "kidney number."

9 Mar 2010

Study: Patients with community-acquired pneumonia who develop AKI more likely to die after discharge

Patients hospitalized with even mild to moderate community-acquired pneumonia who develop acute kidney injury (AKI) are more likely to die after discharge than pneumonia patients whose kidneys remain healthy, according to a University of Pittsburgh School of Medicine study in the February issue of Kidney International.

3 Mar 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Daiichi Sankyo's Benicar receives FDA approval for hypertension treatment in children and adolescents aged 6-16

Daiichi Sankyo, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the hypertension treatment Benicar® (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults.

11 Feb 2010

Patients with high levels of proteinuria have increased risk of all-cause death

Patients with high levels of proteinuria (protein in urine) in addition to another marker of reduced kidney function had an associated increased risk of all-cause death, heart attack or progression to kidney failure, according to a study in the February 3 issue of JAMA.

3 Feb 2010

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

20 Jan 2010

First sulfite-free rectal suspension for UC

sfRowasa™ (mesalamine) Rectal Suspension 4g/60mL –Sulfite-Free Formulation, is the first sulfite-free rectal suspension available for Ulcerative colitis (UC). According to a study published in The American Journal of Gastroenterology, products containing sulfites may exacerbate natural sulfide levels in the colon and may increase inflammation in UC patients. With its sulfite-free preparation, sfRowasa™ offers a new treatment option for the treatment of active, mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

13 Jan 2010

Lead even below level "of concern" for children may impair kidney function

Small amounts of lead in the bodies of healthy children and teens — amounts well below the levels defined as "concerning" by the U.S. Centers for Disease Control and Prevention (CDC) — may worsen kidney function, according to a Johns Hopkins Children's Center study published in the Jan. 11 issue of Archives of Internal Medicine.

12 Jan 2010

Phase II clinical trial of Gilead Sciences' elvitegravir, GS 9350 and Truvada meets primary objective

Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.

7 Jan 2010

Acute kidney injury associated with increased long-term mortality

Patients with sudden loss of kidney function, called acute kidney injury (AKI), are more likely to die prematurely after leaving the hospital—even if their kidney function has apparently recovered, according to an upcoming study inJournal of the American Society of Nephrology (JASN).

18 Dec 2009

INS cites FDA-approved Totect antidote for anthracycline extravasations

The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect(®), the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.

15 Dec 2009

ZYPREXA RELPREVV approved by FDA

The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company announced today.

14 Dec 2009

Study: Ethyl nitrite improves blood flow and organ status during laparoscopy

As good as laparoscopy is in preventing some of the stresses of open surgery on the body, it does have drawbacks, including reduced blood flow and organ dysfunction. Laparoscopy is a type of surgery in the abdomen done through small incisions.

14 Dec 2009

Pfizer announces IES analysis of Aromasin in breast cancer recurrence

Pfizer today announced results from an exploratory analysis of the Intergroup Exemestane Study (IES) at a median follow-up of 91 months in estrogen-receptor positive (ER+) or estrogen-receptor unknown (ER-unknown) women that looked at breast cancer free survival (BCFS) and censored deaths that occurred prior to breast cancer relapse.

11 Dec 2009

New IME-developed cardiac biomarker testing system saves time

Scientists at Singapore's Institute of Microelectronics (IME) have developed a rapid and sensitive integrated system to test simultaneously for specific cardiac biomarkers in finger prick amount of blood.

9 Dec 2009