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

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. [More]
ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

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. [More]
SYNERA can help prevent needle stick pain associated with superficial IVs

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. [More]
Researchers identify target molecules for development of new allergy drugs

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. [More]
Researchers identify several target molecules suitable for development of new allergy drugs

Researchers identify several target molecules suitable 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. [More]
UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

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

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. [More]
rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

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. [More]
FDA approves Xolair for treatment of chronic idiopathic urticaria

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. [More]
FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

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. [More]
Anaphylaxis Campaign provides updated information on Idiopathic anaphylaxis

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. [More]
Mallinckrodt announces commercial launch of PENNSAID

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. [More]
FDA approves New Drug Application for PENNSA 2%

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). [More]
FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

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. [More]
FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

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. [More]
Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

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. [More]
Crealta to acquire all assets of Savient Pharmaceuticals

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. [More]
EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

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. [More]
FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

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. [More]
FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

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. [More]