Angioedema News and Research

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Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis.

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 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

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

CSL Behring receives marketing approval for HAE drug Berinert in Israel

CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

28 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Celgene International Sàrl today announced that data from a randomised clinical study conducted by the Eastern Cooperative Oncology Group (ECOG) were presented at the 52nd Annual Meeting of the American Society of Hematology comparing REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) to lenalidomide plus high-dose dexamethasone (RD) in both younger and older newly-diagnosed multiple myeloma patients (NDMM).

7 Dec 2010

Idis to manage ViroPharma's named patient program

ViroPharma Incorporated and Idis, the global leader in developing long-term strategic solutions to therapeutic access, today announced that the two companies have partnered to facilitate access to certain ViroPharma products through a named patient program (NPP). ViroPharma's NPP, developed and managed by Idis, will allow international healthcare professionals to prescribe certain products to individual patients until the time that approval is sought in local countries.

7 Dec 2010

Study: REVLIMID and dexamethasone for high-risk smoldering multiple myeloma reduce risk of disease progression

Celgene International Sàrl (NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology's annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.

6 Dec 2010

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 Dec 2010

Shire reports topline results from FAST-3 Firazyr Phase III trials for acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).

2 Dec 2010

AMAG updates product label of Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme (ferumoxytol) Injection for intravenous (IV) use.

29 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010