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.

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Dermatologists offer preventative tips to minimize pesky skin problems caused by plants

What may start as a seemingly harmless day of gardening or yard work can quickly take a turn for the worse when common plants make their mark on the skin, causing a host of mild to even severe skin reactions. That is why dermatologists are arming outdoor enthusiasts with preventative tips to keep these perils of the great outdoors at arm's length.

4 Feb 2011

Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL in males were published in the February 3 issue of the New England Journal of Medicine.

3 Feb 2011

Phase III study affirms safety and efficacy of Cumberland's Caldolor for post-operative pain

Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor® (ibuprofen) Injection in treating post-operative pain in hospitalized patients. A Phase III study published in the peer-reviewed journal Pain Practice concluded that IV ibuprofen significantly reduced both morphine use and self-reported pain intensity in patients recovering from abdominal hysterectomy compared to morphine alone.

27 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

ISTA commences bepotastine besilate nasal spray Phase 2 study in seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of bepotastine besilate, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.

14 Dec 2010

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

7 Dec 2010

Arthritis Foundation, Covidien join forces to help Americans suffering from osteoarthritis

The Arthritis Foundation and Covidien have joined forces to help advance awareness and support for millions of people suffering from osteoarthritis in the United States.

23 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

FDA approves Sun Pharma's generic Clarinex ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted it an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Schering Plough's Clarinex® tablets, 5 mg.

18 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Dyax to present data of KALBITOR inhibitor for Angioedema at ACAAI Meeting

Dyax Corp. today announced that an abstract featuring KALBITOR (ecallantide) data was accepted for oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 11-16, at the Phoenix Convention Center in Phoenix, AZ. Two additional abstracts were selected as poster sessions.

15 Nov 2010

Covidien analysis finds lower incidence of GI adverse events with topical NSAIDs versus oral

Covidien, a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).

10 Nov 2010

ACTEMRA reduces signs, symptoms in patients with rheumatoid arthritis

Genentech, Inc., a member of the Roche Group today announced updated data from a Phase III study (ROSE) that showed rheumatoid arthritis (RA) patients receiving ACTEMRA (tocilizumab) experienced a rapid, measured response as early as one week after beginning ACTEMRA, and improvement in disease activity within four weeks.

8 Nov 2010

Merz to present data on Xeomin clinical studies for cervical dystonia at AAPM&R

Merz Pharmaceuticals announced today that data from stability and clinical studies evaluating Xeomin (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, will be presented at the 71st Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) in Seattle, Wash.

8 Nov 2010

National Jewish Health's chronic urticaria diagnostic assay receives US patent

National Jewish Health has received a US patent for a method of detecting autoimmune chronic urticaria, which will help assure many patients that dramatic changes in lifestyle are not needed to treat the condition.

2 Nov 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010