Urticaria News and Research RSS Feed - Urticaria News and Research

Urticaria are itchy, raised red areas on the skin. Urticaria are caused by a reaction to certain foods, drugs, infections, or emotional stress. Also called hives.

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. [More]
GE Healthcare seeks approval to supply Optison to EU market from Oslo manufacturing facility

GE Healthcare seeks approval to supply Optison to EU market from Oslo manufacturing facility

GE Healthcare today announced that it has submitted an application to amend its European Marketing Authorisation that will allow the company to manufacture Optison 0.19 mg/ml dispersion for injection within its own facility. [More]

Study: Drug normally used to treat severe bronchial asthma beneficial for chronic urticaria sufferers

An international study involving dermatologists from the Hospital del Mar and Spanish subjects has concluded that a drug normally used to treat severe bronchial asthma caused by allergies (Omalizumab) rapidly eliminates the symptoms of spontaneous chronic urticaria, a development that it is expected will significantly improve the quality of life of chronic urticaria sufferers. [More]

Omalizumab scratches the itch for urticaria patients

The monoclonal antibody omalizumab seems to be effective at relieving symptoms for patients with chronic idiopathic urticaria who have not responded to H1-antihistamine therapy, report US researchers. [More]
Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia. [More]

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. [More]

Omalizumab fast, safe and well-tolerated in teens and adults with chronic spontaneous urticaria

An international team of researchers has found that a once-a-month, high-dose injection of a commonly used asthma drug is highly effective in treating teens and adults chronically afflicted with hives and severe, itchy rash. The drug, omalizumab, was tested on 323 people at 55 medical centers for whom standard antihistamine therapy failed to quell their underlying, allergy-like reaction, known as chronic idiopathic urticaria or chronic spontaneous urticaria. [More]

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]. [More]
UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

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). [More]

rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women

rEVO Biologics announced today the results of a major retrospective study analysis of its pivotal phase 3 studies which demonstrate that pregnant patients with hereditary antithrombin deficiency (HD) benefit from ATryn Antithrombin (Recombinant) therapy to prevent venous thromboembolic events (VTE). [More]

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. [More]

FDA approves GSK’s raxibacumab to treat inhalational anthrax

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. [More]

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

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. [More]
Allergy Centre of the Charité-Universitätsmedizin Berlin to host three international scientific conferences

Allergy Centre of the Charité-Universitätsmedizin Berlin to host three international scientific conferences

The Allergy Centre of the Charité-Universitätsmedizin Berlin will host three international scientific conferences in the upcoming week. According to Prof. Marcus Maurer, Associate Director of the Allergy Centre at the Clinic for Dermatology, Venereology and Allergology: "Allergological issues have been gaining in importance among clinical physicians." Prof. Mauer explains that all three conferences are focused on enabling scientific exchange about basic allergy research: "Our intent is to offer clinical physicians the opportunity to learn something about the cells, the basis for allergological illnesses. [More]
General guidelines to understand allergic skin conditions

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). [More]

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. [More]
AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

AstraZeneca today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population. [More]

AMAG receives Swiss marketing authorization for ferumoxytol to treat iron deficiency anemia

AMAG Pharmaceuticals, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease. [More]

Positive preliminary results from Feraheme phase III study on iron deficiency anemia

AMAG Pharmaceuticals, Inc. today reported preliminary results from the second phase III study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause. [More]