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Risperdal lawsuit settlement: Largest Medicaid fraud case in Texas

Texas and Janssen Pharmaceuticals reach a $158 million settlement on a suit claiming that the company lied about the efficacy of the anti-psychotic medicine.

21 Jan 2012

FDA allows marketing of Stratify JCV Antibody ELISA test for PML

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn's disease.

21 Jan 2012

FDA approves product label change for Biogen Idec's TYSABRI to treat MS

Today Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis.

21 Jan 2012

ARCA biopharma receives method patent for treatment with bucindolol based on genetic targeting

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office has issued a patent on methods for determining whether to administer or prescribe bucindolol to a patient based on whether the patient has a specific genotype - homozygous for the arginine 389 polymorphism in the beta-1 adrenergic receptor.

20 Jan 2012

Combination of gefitinib and miRNA-inhibitor might effectively treat NSCLC

New research published in Nature Medicine indicates that targeted drugs such as gefitinib might more effectively treat non-small cell lung cancer if they could be combined with agents that block certain microRNAs.

20 Jan 2012

CHORI senior scientist reveals mechanism for iron absorption from non-meat sources

A groundbreaking study conducted by Children's Hospital Oakland Research Institute (CHORI) Senior Scientist Elizabeth Theil, PhD, is the first to reveal the existence of at least two independent mechanisms for iron absorption from non-meat sources-and a potential treatment for iron deficiency, the most common nutrient deficiency worldwide.

20 Jan 2012

Shortages of anti-infective drugs can put patients at risk and alter clinical care

Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online.

20 Jan 2012

EMA CHMP may issue an opinion on CTI's Pixuvri MAA in mid-Feb.

Cell Therapeutics, Inc. ("CTI") announced today that, following discussions with the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), the CHMP may issue an opinion on CTI's Marketing Authorization Application ("MAA") for Pixuvri in mid-February.

20 Jan 2012

New research could lead to cheaper, easier production of malaria drug artemisinin

"Artemisinin, a crucial drug in the global fight against malaria, could soon become cheaper and easier to make, thanks to researchers who have found a better way to synthesize the compound," Science NOW reports, providing an overview of the research published in Angewandte Chemie on Monday.

20 Jan 2012

New federal drug label recommendations for CKD patients

The U.S. Food and Drug Administration (FDA) recently recommended that clinicians be more conservative when they prescribe chronic kidney disease (CKD) patients with drugs that treat red blood cell deficiencies. But the drug label's recommendations fall short, according to two commentaries appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology.

20 Jan 2012

Anabolic steroids do not appear to contribute to CTE

Anabolic steroids don't appear to contribute to degenerative brain disease caused by repeated head trauma in athletes, according to a study in the January issue of Neurosurgery, official journal of the Congress of Neurological Surgeons.

20 Jan 2012

Scientists decode unknown mechanism of imiquimod in tumour defense

A research team from the Institute for Cancer Research at the MedUni Vienna has decoded a previously unknown mechanism of the active ingredient imiquimod in tumour defense. They have been able to prove that imiquimod transforms plasmacytoid dendritic cells (pDCs) into "tumour-killers" which can fight the tumour independently from other immune cells. This discovery could be an important step on the way to a more efficient treatment for cancer.

20 Jan 2012

Clues about how statins might treat breast cancer

Cholesterol-lowering statins seem to keep breast cancer at bay in some patients. Now researchers reporting in the January 20th issue of the journal Cell, a Cell Press publication, provide clues about how statins might yield those unexpected benefits. The findings also suggest that mutations in a single gene could be used to identify tumors likely to respond to statin therapy.

19 Jan 2012

Mylan introduces Levetiracetam to treat seizures

Mylan Inc. today announced that its Mylan Institutional business has launched Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL, for intravenous use.

19 Jan 2012

Study examines drug resistance in ALK positive lung cancer

Scientists from the University of Colorado Cancer Center have once again advanced the treatment of a specific kind of lung cancer. The team has documented how anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) becomes resistant to a drug targeting the abnormal protein in the cancer. It's the first time scientists have analyzed the frequency and type of drug resistance in ALK positive patients taking crizotinib.

19 Jan 2012

FDA issues complete response letter to Bristol-Myers Squibb and AstraZeneca's dapagliflozin

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults.

19 Jan 2012

New vaccine for deadly meningococcus B

A new study shows that a new 4-component meningococcal (4CMenB) vaccine for teenagers is effective when administered on a schedule of 2 doses from 1 to 6 months apart. María Elena Santolaya, from the Department of Pediatrics, University of Chile, Santiago, and colleagues performed the study, which was published online January 18 in the Lancet.

19 Jan 2012

Study demonstrates possibility of curing hepatitis C without use of interferon

Bristol-Myers Squibb Company today announced the full results, published in the New England Journal of Medicine, from a Phase II clinical trial in patients with hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin ('null responders').

19 Jan 2012

SSRIs increase risk of falling in nursing home residents with dementia

Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are three times more likely to have an injurious fall than similar people who don't use these drugs. The association can be seen in people who use low doses of SSRIs and the risk increases as people take higher doses. The results are published in the British Journal of Clinical Pharmacology.

19 Jan 2012

Mephedrone users would switch to a new legal high if it caused less harm

Since mephedrone was made illegal in the UK in 2010, the street price of the drug has risen while the quality has degraded, which in turn may have reduced use of the drug. New research published online today reveals that young people who continued to use mephedrone after it became illegal would switch to a new legal high if it were pure and rated highly by their friends or on the Internet.

19 Jan 2012