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.

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck's investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting.

11 Apr 2013

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

4 Apr 2013

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

BioCryst Pharmaceuticals, Inc. announced that it received a preliminary comment letter from the U.S. Food & Drug Administration that outlines a pathway by which BioCryst could file a New Drug Application seeking regulatory approval of intravenous (i.v.) peramivir.

1 Apr 2013

BioCryst starts BCX4161 Phase 1 clinical trial for treatment of hereditary angioedema

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX4161 in healthy volunteers.

25 Mar 2013

Baxter files FEIBA NF BLA with FDA for prophylactic treatment of hemophilia A or B

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

From Baxter International Inc. 26 Feb 2013

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen, immune globulin intravenous [human].

21 Feb 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

BioCryst fourth quarter revenues decrease to $4.1 million

BioCryst Pharmaceuticals, Inc. announced financial results for the fourth quarter and full year ended December 31, 2012.

19 Feb 2013

FDA approves Novartis’ Zortress to prevent organ rejection after liver transplantation in adults

Novartis announced today that the US Food and Drug Administration (FDA) has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

16 Feb 2013

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today the U.S. commercial launch of UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

14 Feb 2013

Dyax fourth quarter total revenues increase to $16.0 million

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2012.

14 Feb 2013

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

28 Jan 2013

FDA approves Santarus’ UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

16 Jan 2013

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

AstraZeneca today announced the presentation of important new data from studies of FASLODEX (fulvestrant) Injection at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B. Gonzalez Convention Center, San Antonio, Texas.

5 Dec 2012

Top-line results from Pfizer's pregabalin CR formulation Phase 3 study on fibromyalgia

Pfizer Inc. announced that top-line results of a double-blind, Phase 3 study evaluating pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicate that pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR).

20 Nov 2012

General guidelines to understand allergic skin conditions

Winter months can bring on the itch as cold weather and indoor heat dry out the skin. It's possible, suggests Chicago allergist, Brian Rotskoff, MD of Clarity Allergy Center, that your winter itch could be caused by more than just the weather. For some people itchy, dry skin is just that, but for others it can be a symptom of atopic dermatitis (eczema), contact dermatitis, or hives (urticaria).

16 Nov 2012

Leading allergy organizations release report that sheds light on angioedema

With today's modern medicine, misdiagnoses may be unexpected and surprising. But when symptoms of an unknown and uncommon illness mimic a number of other conditions, it can be difficult for medical professionals to properly diagnose and treat patients. That's why four leading allergy/immunology organizations have announced the release of a report to help set a new standard for a commonly misdiagnosed, under-recognized and under treated condition known as angioedema, the rapid swelling of deep layers of skin and tissue.

9 Nov 2012