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.

Preoperative IV ibuprofen improves quality of recovery after laparoscopic cholecystectomy surgery

Cumberland Pharmaceuticals Inc. today announced that preoperative intravenous ibuprofen improved overall quality of recovery in patients undergoing laparoscopic cholecystectomy surgery. These results will be presented at the American Anesthesiology 2014 Annual Meeting in New Orleans, Louisiana.

12 Oct 2014

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204).

23 Sep 2014

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.

From Baxter International Inc. 22 Aug 2014

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

30 Jun 2014

SYNERA can help prevent needle stick pain associated with superficial IVs

Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows SYNERA® (lidocaine and tetracaine) topical patch to be used at home.

4 Jun 2014

Researchers identify target molecules for development of new allergy drugs

Researchers have identified several target molecules which are suitable for the development of new allergy drugs. The Journal of Allergy and Clinical Immunology, the most prestigious journal in the field of allergology, has recently published an extensive review article on the prospects of drug therapy for allergy. Completed in a large-scale EU project, the lead author of the review article is Professor Ilkka Harvima of the University of Eastern Finland and Kuopio University Hospital.

13 May 2014

Researchers identify several target molecules suitable for development of new allergy drugs

13 May 2014

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

21 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

FDA approves Xolair for treatment of chronic idiopathic urticaria

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, a form of chronic hives.

24 Mar 2014

FDA approves Iroko Pharmaceuticals’ TIVORBEX 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 TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

25 Feb 2014

Anaphylaxis Campaign provides updated information on Idiopathic anaphylaxis

Most people have heard of severe allergies, or anaphylaxis, to food, insect stings, drugs and other common substances, but sometimes no cause at all can be found for a person’s reaction – a condition called Idiopathic anaphylaxis.

21 Feb 2014

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees.

10 Feb 2014

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s).

17 Jan 2014

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

15 Jan 2014

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

From Baxter International Inc. 20 Dec 2013

Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

13 Dec 2013

Crealta to acquire all assets of Savient Pharmaceuticals

Savient Pharmaceuticals, Inc. ("Savient") announced that it has reached agreement on the terms of an acquisition agreement with Crealta Pharmaceuticals LLC ("Crealta") through which Crealta would acquire substantially all of the assets of Savient, including all KRYSTEXXA® assets, for gross proceeds of approximately $120.4 million.

11 Dec 2013