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.

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

FDA grants orphan drug exclusivity approval for Octapharma AG's wilate

Octapharma AG, one of the largest manufacturers of plasma products in the world, today announced that it has received orphan drug exclusivity approval for wilate® from the U.S. Food and Drug Administration (FDA).

18 Jan 2010

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

CAM314 randomized Phase 3 clinical trial results released

Genzyme Corporation announced data from its CAM314 randomized Phase 3 clinical trial comparing Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) (FluCAM) to Fludara alone in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) demonstrated that the FluCAM regimen significantly reduced the risk of disease progression or death compared to single-agent Fludara.

8 Dec 2009

Data from recent clinical trial for Caldolor Injection to be presented

Cumberland Pharmaceuticals Inc. announced today that data from a recent clinical trial for Caldolor® (ibuprofen) Injection, an intravenous treatment for pain and fever, will be presented at the 44th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Las Vegas, Nevada, in December.

4 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

FDA grants approval for Dyax' KALBITOR for treating HAE patients

Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

2 Dec 2009

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

24 Nov 2009

Caldolor Injection effective in treating fever in hospitalized burn patients

Cumberland Pharmaceuticals Inc. today announced positive new top-line results from a study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in hospitalized burn patients.

23 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

ISTA Pharmaceuticals presents additional data from its Bepreve Phase 3 clinical studies

ISTA Pharmaceuticals, Inc., today announced additional results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies. These results were presented in poster sessions at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Miami Beach, FL.

9 Nov 2009

HAE patients have prodromal symptoms that signal an oncoming HAE attack, reports survey

Most patients with hereditary angioedema (HAE) have prodromal symptoms that signal an oncoming HAE attack giving the patients sufficient time to initiate treatment and decrease the morbidity associated with that attack, according to survey findings presented today at the 2009 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting.

9 Nov 2009

Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Cumberland Pharmaceuticals and Phebra team up to commercialize Caldolor injection

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, today announced they have entered into an exclusive partnership for the commercialization of Caldolor® (ibuprofen) Injection in Australia and New Zealand.

30 Oct 2009

New data from CIMZIA WELCOME trial to be presented at the ACG meeting

According to new results from the WELCOME trial, exploratory data analyzing the impact of treatment with CIMZIA(®) (certolizumab pegol) - the only PEGylated anti-TNF (alpha) (Tumor Necrosis Factor alpha) - administered either every two weeks or every four weeks, showed that the majority of Crohn's disease patients in both dosing groups experienced no hospitalizations and surgical procedures during the course of the 26-week study.

28 Oct 2009

King Pharmaceuticals receives exclusive rights to market and sell CYANOKIT

King Pharmaceuticals, Inc. announced today that it has licensed from Merck Santé S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany, the exclusive rights to market and sell CYANOKIT® 5 g (hydroxocobalamin for injection) ANTIDOTE in the U.S. CYANOKIT® is indicated for the treatment of known or suspected cyanide poisoning, typically caused by smoke inhalation from fires.

28 Oct 2009

New data from efficacy study of CIMZIA in Crohn's disease patients presented

New data from an open-label extension study evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol) in moderate to severe Crohn's disease patients demonstrate that 82 percent of patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha (Tumor Necrosis Factor alpha) - remained in long-term remission without dose escalation up to 3.5 years.

27 Oct 2009

Theravance earns milestone payment for bactericidal, injectable lipoglycopeptide antibiotic

Theravance, Inc. announced today that it has earned a milestone payment of $20 million for the U.S. Food and Drug Administration (FDA) approval of VIBATIV (telavancin) and supplying its collaboration partner, Astellas Pharma US, Inc. (Astellas), with the launch inventory for the first commercial sale in the United States.

23 Oct 2009

ISTA Pharmaceuticals' presentations on Phase 3 clinical results of Bepreve

ISTA Pharmaceuticals, Inc. today announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age.

22 Oct 2009