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Title: News and Media - FDAnews An electronic division of Washington Business Information Inc. with news on drugs, medical devices, and biologics.
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NEJM Files Amicus Brief in Supreme Court Preemption Case

Drugmakers Merck, Wyeth and Bayer Healthcare withheld important information from the FDA regarding the safety of certain drugs, costing tens of thousands of lives, according to 10 former and current editors and authors of The New England Journal of Medicine (NEJM). Read More 

FDA Warns of Injection Site Risks With Vivitrol

The FDA is warning healthcare professionals of the risk of adverse injection site reactions in patients receiving Alkermes and Cephalon’s alcohol dependence drug Vivitrol after receiving almost 200 reports of such reactions. Read More 

Sanofi Sues Apotex Over Taxotere Cancer Drug

Sanofi-Aventis is suing Canadian drugmaker Apotex for filing an ANDA to market a generic version of the cancer treatment Taxotere. Read More 

Boston Scientific Faces Obstacles, Awaits Lifting of Warning Letter

While waiting for the FDA to lift its 2-year-old corporate warning letter, Boston Scientific is facing some new challenges. Read More 

St. Jude Gets CE Marking, FDA Clearance for Surgical Ablation Products

St. Jude Medical has received CE Marking and FDA clearance for its Epicor LP cardiac ablation system, which uses high intensity focused ultrasound (HIFU) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart. Read More 

Draeger MRI Receives FDA Clearance

The FDA granted clearance to Draeger Medical for its Fabius MRI anesthesia machine. Read More 

More Top Stories

Sponsored by: az_adjs(99,'fda3b64690');TOP STORIES TOP DEVICE STORIESTOP DRUG STORIES RSS 

Boston Scientific Faces Obstacles, Awaits Lifting of Warning Letter

While waiting for the FDA to lift its 2-year-old corporate warning letter, Boston Scientific is facing some new challenges. Read More 

St. Jude Gets CE Marking, FDA Clearance for Surgical Ablation Products

St. Jude Medical has received CE Marking and FDA clearance for its Epicor LP cardiac ablation system, which uses high intensity focused ultrasound (HIFU) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart. Read More 

Draeger MRI Receives FDA Clearance

The FDA granted clearance to Draeger Medical for its Fabius MRI anesthesia machine. Read More 

Devicemakers Subject to Massachusetts Physician Gift Law

Devicemakers doing business in Massachusetts will have to report all gifts worth more than $50 given to authorized prescribers, dispensers and purchasers in the state under a new law signed by Gov. Deval Patrick. Read More 

Clinical Studies Completed for Heart Screening System

Pegasus Pharmaceuticals has completed clinical studies for use of its HeartVue 6S Heart Screening System in the U.S. Read More 

Biotest Receives FDA Clearance for Blood Bank Reagents

The FDA gave marketing clearance for Biotest Diagnostics’ full line of traditional blood bank reagents. Read More 

More Top Device Stories

TOP STORIES TOP DEVICE STORIES TOP DRUG STORIESRSS 

FDA Warns of Injection Site Risks With Vivitrol

The FDA is warning healthcare professionals of the risk of adverse injection site reactions in patients receiving Alkermes and Cephalon’s alcohol dependence drug Vivitrol after receiving almost 200 reports of such reactions. Read More 

Sanofi Sues Apotex Over Taxotere Cancer Drug

Sanofi-Aventis is suing Canadian drugmaker Apotex for filing an ANDA to market a generic version of the cancer treatment Taxotere. Read More 

Dyax to Finish BLA for Angioedema Drug This Fall

Dyax will complete its rolling BLA submission for its DX-88 investigational treatment for hereditary angioedema early in the fourth quarter, based on positive results from a second Phase III trial. Read More 

ImClone Begins Phase III Study for Metastatic Breast Cancer

ImClone Systems has treated its first patient in a Phase III clinical trial of IMC-1121B, its antivascular endothelial growth factor receptor-2 monoclonal antibody, in women with metastatic breast cancer. Read More 

Bioniche Phase III Trial in Bladder Cancer Progressing

Bioniche Life Sciences has received positive feedback from its data safety monitoring committee for the company’s first Phase III clinical trial using Urocidin to treat non-muscle-invasive bladder cancer. Read More 

More Top Drug Stories

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An

electronic

division

of

Washington

Business

Information

Inc.

with

news

on

drugs,

medical

devices,

and

biologics.

http://www.fdanews.com/

FDAnews 2008 August

dvd rental

dvd


An electronic division of Washington Business Information Inc. with news on drugs, medical devices, and biologics.

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