Edema News and Research

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Edema means swelling caused by fluid in your body's tissues. It usually occurs in the feet, ankles and legs, but it can involve your entire body.

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Results from a Phase 2, 8-week dose-ranging study using low doses of atrasentan in patients with diabetic kidney disease were published this week in the Journal of the American Society of Nephrology. The published study results suggest that atrasentan, used in conjunction with renin-angiotensin system inhibitors, may reduce albuminuria (presence of protein in urine) for patients with type 2 diabetes.

5 Mar 2011

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II hereditary angioedema (HAE) attacks licensed for self-administration in Europe.

4 Mar 2011

RMEI, PIM sponsor medical education monograph on HAE

Hereditary angioedema is an autosomal dominant disorder resulting from a deficiency in functional C1 inhibitor. Manifestations include recurrent episodes of nonpitting subcutaneous and submucosal edema involving the skin, airway, and visceral organs.

2 Mar 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.

22 Feb 2011

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema.

22 Feb 2011

New research: Fluid retention may explain drugs' risk of strokes and heart attacks

New research shows that medications which have raised safety concerns over heart attack and stroke risks may not have gotten approval from the Food and Drug Administration if the cardiovascular effects of fluid retention had been better understood. Fluid retention may explain the increased risk of heart attacks and strokes of medications such as Vioxx, Bextra, and Avandia.

22 Feb 2011

Positive results from Medtronic CoreValve System study for treatment of aortic valve disease

Medtronic, Inc. today issued a statement on results from an independent study published online in the journal Circulation, which confirmed both early and sustained clinical benefits for patients receiving the Medtronic CoreValve® System for the treatment of aortic valve disease.

19 Feb 2011

Positive outcomes from first surgery using Zimmer's DeNovo NT Graft for repair of cartilage lesions

Zimmer Holdings, Inc., a global leader in musculoskeletal care, today announced that results from a peer-reviewed publication demonstrated positive outcomes from the first surgery performed using the DeNovo NT Graft for the repair of cartilage lesions.

19 Feb 2011

FDA grants 510(k) clearance to Venous Health's Vasculaire Compression System in the US

Venous Health Systems, a developer of solutions for treating vascular insufficiency by enhancing blood circulation, today announced that it has received 510 clearance from the Food & Drug Administration to market the Vasculaire Compression System in the United States.

15 Feb 2011

State court jury rules in favor of Merck in FOSAMAX trial

Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use.

15 Feb 2011

Phase III RISE study of Lucentis for DME meets primary endpoint

Genentech, Inc., a member of the Roche Group, announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.

14 Feb 2011

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Patient need to share medication side effects with health care team: Retired family doctor

"I had a wonderful gentleman patient who had resistant blood pressure," recalls Vicki Koenig, M.D., a retired family doctor in Exmore, VA. "When he came for a blood pressure check on the latest new med and it was great, I was ecstatic. Then he said, 'But I notice my urine's a little dark.' His was one of the first cases of fatal liver complications from this medication."

5 Feb 2011

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.

4 Feb 2011

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN for the treatment of Diabetic Macular Edema, today announced month 36, top-line readout results for the FAME Study prepared by its licensee, Alimera Sciences.

4 Feb 2011

Edema News and Research

Further Reading

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

RMEI, PIM sponsor medical education monograph on HAE

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

AMAG fourth quarter total revenues increase to $17.2 million

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

New research: Fluid retention may explain drugs' risk of strokes and heart attacks

Positive results from Medtronic CoreValve System study for treatment of aortic valve disease

Positive outcomes from first surgery using Zimmer's DeNovo NT Graft for repair of cartilage lesions

FDA grants 510(k) clearance to Venous Health's Vasculaire Compression System in the US

State court jury rules in favor of Merck in FOSAMAX trial

Phase III RISE study of Lucentis for DME meets primary endpoint

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

Patient need to share medication side effects with health care team: Retired family doctor

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

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