FDA News

Company Grants License to Its Diabetes Biomarkers

Jody A. Charnow March 02, 2010

Intrinsic Bioprobes, of Tempe, Ariz.,a privately held biotechnology company, has licensed two novel biomarkers for diabetes to Ortho-Clinical Diagnostics, Inc., of Raritan, N.J.
 

Gambro Acquires Medical Device Company

Jody A. Charnow March 02, 2010

Gambro, which has its U.S. headquarters in Lakewood, Colo., has acquired CHF Solutions, a privately held medical device company in Brooklyn Park, Minn., that manufactures and distributes ultrafiltration devices to treat fluid overload, both companies announced recently.
 

Fresenius Buys the Company That Sells Acumen nEHR

Jody A. Charnow March 02, 2010

Fresenius Medical Care North America (FMCNA), headquartered in Waltham, Mass., has acquired Nashville-based Health IT Services Group and its portfolio of products, including Acumen nEHR, a nephrology-specific electronic health record.
 

Drug Cleared for Treating Moderate to Severe Rheumatoid Arthritis

Jody A. Charnow March 02, 2010

Roche has received marketing clearance for Actemra (tocilizumab) as a treatment for moderate to severe active rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more treatments that block tumor necrosis factor.
 

FDA Warns Consumers about Counterfeit Weight-Loss Product

Jody A. Charnow March 02, 2010

The FDA has issued a warning to consumers about a counterfeit and possibly harmful version of Alli 60 mg capsules (120 count refill kit). Alli is an over-the-counter weight-loss product.
 

Wyeth Makes Drug Monitoring Changes for Sirolimus

Jody A. Charnow March 02, 2010

Wyeth has notified health care professionals of changes to the Rapamune (sirolimus) prescribing information related to changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of the medication, according to the FDA.
 

Fentanyl Patch Lot Is Recalled

Jody A. Charnow September 17, 2009

Watson Pharmaceuticals is voluntarily recalling one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States, according to a company press release.
 

NJ Hospitals To Test System of Incentives

Jody A. Charnow September 17, 2009

A dozen hospitals in New Jersey and their affiliated physicians are participating in the Physician Hospital Collaboration Demonstration, a Medicare project to evaluate a program aimed at reducing health-care costs and improving quality of care.
 

Light-Activated Drug for BPH Enters Phase 2 Clinical Trial

Jody A. Charnow September 17, 2009

Researchers recently treated the first patients who are participating in a phase 2 clinical trial of a novel therapy for benign prostatic hyperplasia (BPH).
 

Aliskiren-HCTZ Combo Okayed as First-Line Therapy

Jody A. Charnow September 17, 2009

Tekturna HCT, a single-pill combination of aliskiren—the first and only approved direct renin inhibitor—and hydrochlorothiazide (HCTZ) has been approved as initial therapy for patients who are likely to need multiple drugs to achieve their BP.
 
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