Urticaria News and Research

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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.

EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

Janssen-Cilag International NV announced today that the European Commission has approved INVOKANA (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control[1]. Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors.

23 Nov 2013

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products.

19 Oct 2013

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis.

18 Oct 2013

FDA accepts, files Genentech's sBLA for subcutaneous use of Xolair in people with CIU

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted and filed the company's supplemental Biologics License Application for subcutaneous use of Xolair (omalizumab) in people with Chronic Idiopathic Urticaria who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses.

11 Oct 2013

FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis.

30 Sep 2013

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

From Baxter International Inc. 5 Jul 2013

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire plc, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association 166th Annual Meeting in San Francisco, May 18-22.

20 May 2013

Boehringer Ingelheim updates HCPs, patients on COMBIVENT RESPIMAT Inhalation Spray

As part of the company's commitment to chronic obstructive pulmonary disease patients, Boehringer Ingelheim Pharmaceuticals, Inc., a leader in respiratory health, is updating healthcare professionals and patients that the transition to COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray for the maintenance treatment of COPD is nearly complete.

18 May 2013

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection.

24 Apr 2013

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

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.

30 Mar 2013

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.

21 Mar 2013

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.

5 Mar 2013

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.

1 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

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.

25 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

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).

16 Feb 2013