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Hospira's Nivestim receives Australian TGA approval

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration approval for its biosimilar filgrastim product, Nivestim.

27 Sep 2010

Boston releases HORIZONS-AMI trial data

Angiotech Pharmaceuticals, Inc. announced that its corporate partner, Boston Scientific Corporation, has released three-year follow-up data from the HORIZONS-AMI trial.

27 Sep 2010

FDA approves Beyaz tablets to increase folate level in women

The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

27 Sep 2010

Gene alteration impacts brain tumor development: Study

The interaction between a network of altered genes appears to play an important role in the development and progression of brain tumors, according to a study in the July 15 issue of JAMA.

27 Sep 2010

Clinical Data announces Stedivaze agonist data at ASNC2010 meeting

Clinical Data, Inc., today presented data from Phase I studies of Stedivaze (apadenoson), which demonstrated overall safety and tolerability in patients with asthma and chronic obstructive pulmonary disease (COPD).

27 Sep 2010

FDA approves OZURDEX implant for uveitis treatment

Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

27 Sep 2010

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

24 Sep 2010

Concerted effort yields significant progress in reducing depression, HIV/AIDS, and osteoporosis in women

A concerted effort to boost research on women's health over the last two decades has lessened the burden of disease and reduced deaths among women due to cardiovascular disease, breast cancer, and cervical cancer, says a new report from the Institute of Medicine. The effort has yielded less but still significant progress in reducing the effects of depression, HIV/AIDS, and osteoporosis on women, added the committee that wrote the report.

24 Sep 2010

Global leaders announce new commitments to accelerate progress towards ending malaria deaths

Prominent leaders in global health and development joined several African heads of state at UN Headquarters today to announce new commitments to accelerate progress toward ending deaths from malaria, a disease that claims the lives of more than 850,000 Africans each year.

24 Sep 2010

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.

24 Sep 2010

Study: PTNS offers an effective treatment option for detrusor overactivity incontinence

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today highlighted results of a study "Percutaneous Tibial Nerve Stimulation Effects on Detrusor Overactivity Incontinence Are Not Due to a Placebo Effect A Randomized, Double-Blind, Placebo Controlled Trial," to be published in the November 2010 print edition of THE JOURNAL OF UROLOGY.

24 Sep 2010

New data demonstrates safety and efficacy of Resolute drug-eluting stent

Coronary artery disease, a leading cause of death and poor quality of life worldwide, runs the gamut from simple to complex, which complicates the daily practice of interventional cardiology. New clinical data from a second, large international study that enrolled "all comers," regardless of disease complexity and comorbidities, again demonstrated the strong performance of the Resolute drug-eluting stent (DES) from Medtronic, Inc. for patients across this continuum.

24 Sep 2010

PAREXEL Consulting releases two new white papers on biosimilar development

PAREXEL Consulting, a business unit of PAREXEL International and leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released two new white papers from leading biosimilar experts that provide key insights into emerging areas of biosimilar development.

From Parexel 24 Sep 2010

FDA designates AMT-080 gene therapy for Duchenne muscular dystrophy

Amsterdam Molecular Therapeutics (AMT) Holding N.V. a leader in the field of human gene therapy, announced today that the U.S. Food and Drug Administration (FDA) has designated AMT-080, a gene therapy for Duchenne muscular dystrophy (DMD) as an orphan drug.

24 Sep 2010

CIC proposes criteria to improve endpoints for cancer immunotherapy trials

The Cancer Research Institute (CRI) Cancer Immunotherapy Consortium (CIC), the leading global initiative in advancing the emerging field of immuno-oncology, has proposed criteria for improved endpoints for cancer immunotherapy trials, which were published online on September 8 in the Journal of the National Cancer Institute.

24 Sep 2010

Lutonix presents data on Moxy Drug Coated Balloon Catheter at TCT meeting

Lutonix, Inc., headquartered in Minneapolis, MN, today announced six-month data from three separate drug coated balloon studies presented at the TransCatheter Therapeutics (TCT) meeting this week demonstrated the ability of the Moxy Drug Coated Balloon Catheter to inhibit restenosis in both peripheral and coronary arteries.

24 Sep 2010