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Roche's Herceptin formulation wins EU approval for treatment of HER2-positive breast cancer

Halozyme Therapeutics, Inc. announced today that the European Commission has granted Roche European Union marketing authorization for the use of a time-saving subcutaneous formulation of Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer.

2 Sep 2013

Use of anticoagulant does not reduce ischemic events among patients undergoing PCI

Use of the novel anticoagulant otamixaban did not reduce ischemic events compared with unfractionated heparin plus eptifibatide but increased bleeding among patients with non-ST-segment elevation acute coronary syndromes undergoing a percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), according to a study published by JAMA.

2 Sep 2013

CAD patients with very low LDL-C levels benefit from statin treatment

Dr Nakano said: "Many randomised clinical trials, such as Treating to New Targets (TNT) and PROVE IT-TIMI, have shown that aggressive cholesterol lowering with statins improves clinical outcomes in patients with CAD and high LDL-C levels.1,2 But until now it was not known whether aggressive lipid lowering with statins would also benefit CAD patients with very low LDL-C levels."

2 Sep 2013

New delivery system for combination of 2 FDA approved drugs to fight HIV

A University of Minnesota research team featuring researchers from the Institute for Molecular Virology, School of Dentistry and Center for Drug Design has developed a new delivery system for a combination of two FDA approved drugs that may serve as an effective treatment for the human immunodeficiency virus (HIV).

31 Aug 2013

Study describes lack of positive effects in drugs, long-term data and robust direct comparisons in RA

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined 9 biotechnologically produced drugs for the treatment of adults with rheumatoid arthritis in whom prior pharmacological treatment had failed.

31 Aug 2013

Researchers find new form of imaging technology to diagnose different types of cancer

Researchers from University Hospitals Case Medical Center have published findings that a new form of imaging -- PET/MRI -- is promising for several types of cancer.

30 Aug 2013

Mallinckrodt to present MNK-795 clinical data at PAINWeek 2013

Mallinckrodt announced today that the first clinical data on MNK-795 will be presented at PAINWeek 2013, to be held September 4-7 in Las Vegas. MNK-795 is an extended-release oral formulation of oxycodone and acetaminophen that has been studied in clinical trials for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

29 Aug 2013

Reformulated OxyContin®: an interview with Dr. Paul Coplan, Executive Director, Risk Management and Epidemiology, Purdue Pharma

OxyContin contains oxycodone, which is an opioid agonist. It is used for the management of moderate to severe pain when a constant opioid analgesic is needed for a prolonged period of time.

29 Aug 2013

Testosterone improves exercise capacity in men with COPD

A systematic review and meta-analysis confirms that testosterone therapy improves exercise capacity in men with chronic obstructive pulmonary disease.

28 Aug 2013

Inflammatory status upregulated in first-episode schizophrenia

Patients with first-episode schizophrenia exhibit upregulation of key proinflammatory molecules, study findings show.

28 Aug 2013

Alzheimer’s drug trial: an interview with Geoffrey Kempler, Chairman & CEO Prana Biotechnology

Approval for the IMAGINE trial was granted by the Austin Health Research Ethics Committee in November 2011, with the first patients dosed in March the following year. However, well before the trial was approved, PBT2 had already shown promise in significantly changing Abeta levels in spinal fluid while improving cognition in a previous 12-week trial conducted in 2006.

28 Aug 2013

New research focuses on perfectionism to improve treatment for adolescent anorexia

Reducing ‘perfectionistic’ thinking as a way to improve treatment for adolescent anorexia, is the focus of new research by Griffith University.

28 Aug 2013

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX (collagenase clostridium histolyticum) for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013.

28 Aug 2013

Results from Phase II START study published in The Lancet Diabetes & Endocrinology

Results from the START clinical study (Study of Thymoglobulin to Arrest Newly Diagnosed Type 1 Diabetes), led by Dr. Steve Gitelman (University of California, San Francisco) and sponsored by the Immune Tolerance Network, are published today in The Lancet Diabetes & Endocrinology.

28 Aug 2013

USF professor studies ethics of RCT and efficacy in outcomes of new treatments

University of South Florida Distinguished Professor Benjamin Djulbegovic, MD, PhD, has studied the ethics of randomized clinical trials and their effectiveness in evaluating the outcomes of new treatments for decades.

28 Aug 2013

HCV treatment with sofosbuvir and ribavirin results in sustained virologic response

Treatment of chronic hepatitis C virus genotype 1 infection with the interferon-free regimen of sofosbuvir and ribavirin resulted in a high sustained virologic response rate in a patient population with unfavorable treatment characteristics, according to a study in the August 28 issue of JAMA.

28 Aug 2013

Daily doses of calcium and vitamin supplements may not prevent loss of BMD in women

Companion diagnostics: an interview with Trevor Hawkins, SVP, Strategy, Innovation and Business Development for Siemens Healthcare Diagnostics

Companion diagnostics is critical in helping to pave the way for personalized medicine, in which the treatment is adapted and precisely tailored to the patient.

From Siemens Healthineers 27 Aug 2013

Efficacy News and Research

Roche's Herceptin formulation wins EU approval for treatment of HER2-positive breast cancer

Use of anticoagulant does not reduce ischemic events among patients undergoing PCI

CAD patients with very low LDL-C levels benefit from statin treatment

New delivery system for combination of 2 FDA approved drugs to fight HIV

Study describes lack of positive effects in drugs, long-term data and robust direct comparisons in RA

Researchers find new form of imaging technology to diagnose different types of cancer

Mallinckrodt to present MNK-795 clinical data at PAINWeek 2013

Reformulated OxyContin®: an interview with Dr. Paul Coplan, Executive Director, Risk Management and Epidemiology, Purdue Pharma

Testosterone improves exercise capacity in men with COPD

Inflammatory status upregulated in first-episode schizophrenia

Alzheimer’s drug trial: an interview with Geoffrey Kempler, Chairman & CEO Prana Biotechnology

New research focuses on perfectionism to improve treatment for adolescent anorexia

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Results from Phase II START study published in The Lancet Diabetes & Endocrinology

USF professor studies ethics of RCT and efficacy in outcomes of new treatments

HCV treatment with sofosbuvir and ribavirin results in sustained virologic response

Daily doses of calcium and vitamin supplements may not prevent loss of BMD in women

New tool may make surgery more viable option for OSAHS sufferers

Lipidor announces positive results from Phase I/IIa study of AKVANO/calcipotriol for psoriasis vulgaris

Companion diagnostics: an interview with Trevor Hawkins, SVP, Strategy, Innovation and Business Development for Siemens Healthcare Diagnostics

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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