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.

Astellas announces positive results from mirabegron phase III trials against OAB

Astellas Pharma Inc. today announced the results of two pivotal phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder, show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition.

23 Mar 2011

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.

21 Mar 2011

Quark Pharmaceuticals receives results from Phase 2 trial of PF-04523655 in patients with DME

Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced that it has received results from a prospective randomized Phase 2 trial, the DEGAS study.

19 Mar 2011

Genentech announces positive outcomes from Lucentis Phase III trial against DME

Genentech, a member of the Roche Group, today announced that two-year results from a pivotal Phase III trial showed patients with diabetic macular edema who received Lucentis experienced rapid and sustained improvement in vision compared to those who received a placebo injection.

11 Mar 2011

Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya, has received Notice of Compliance in Canada.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Grifols receives FDA approval for Alphanate to treat vCJD

Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain today announced that it received approval from the US Food and Drug Administration for revised labeling for Alphanate Antihemophilic Factor/von Willebrand Factor Complex indicating that certain manufacturing steps have been shown to reduce the infectivity of a experimental TSE agent that is a model for variant Creutzfeldt Jakob Disease.

5 Mar 2011

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

Edema News and Research

Further Reading

Astellas announces positive results from mirabegron phase III trials against OAB

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Quark Pharmaceuticals receives results from Phase 2 trial of PF-04523655 in patients with DME

Genentech announces positive outcomes from Lucentis Phase III trial against DME

Novartis new MS treatment receives Notice of Compliance in Canada

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

FDA approves change to prescribing information for Gilead Sciences' Letairis

Grifols receives FDA approval for Alphanate to treat vCJD

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

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