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.

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

GE Healthcare highlights molecular imaging technologies to help clinicians improve patient experiences

Focusing on helping clinicians improve experiences for their patients, GE Healthcare is highlighting an innovative portfolio of molecular imaging technologies and agents at the 57th annual meeting of the Society of Nuclear Medicine, June 5-9, in Salt Lake City.

7 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

Studies and analyses of the Crohn’s Disease (CD) treatment Cimzia® (certolizumab pegol) demonstrating new data will be exhibited at Digestive Disease Week (DDW) 2010, taking place in New Orleans from May 1-5, 2010.

30 Apr 2010

Nuvo Research's PENNSAID now available in U.S. pharmacies

Nuvo Research Inc., a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.

27 Apr 2010

Covidien introduces PENNSAID to the U.S. market

Covidien, a leading global provider of healthcare products, has introduced PENNSAID (diclofenac sodium topical solution) 1.5% w/w to the U.S. market. PENNSAID is the only FDA-approved topical non-steroidal anti-inflammatory drug in a vehicle solution containing dimethyl sulfoxide, a known penetrating agent. It is indicated for treatment of the signs and symptoms of osteoarthritis of the knee(s).

26 Apr 2010

Ibuprofen demonstrates efficacy over acetaminophen for treatment of pain and fever

Cumberland Pharmaceuticals Inc. today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.

15 Apr 2010

Genzyme presents 4-year follow-up data from Phase 2 MS trial at neurology meeting

Genzyme Corporation today reported four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial showing an estimated 71 percent of alemtuzumab treated patients remain free of clinically-active disease as much as three years after most patients received their last course of the investigational compound. The data were presented at the American Academy of Neurology annual meeting.

15 Apr 2010

Phase II GAMMAGARD clinical study for Alzheimer's disease: 18-month results announced

Baxter International Inc. and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimer's disease. This marked the first announcement of clinical trial results measuring function and cognition in patients who received uninterrupted GAMMAGARD for a period of 18 months.

From Baxter International Inc. 15 Apr 2010

Survey reveals Gamunex as preferred IGIV therapy among neurologists

Talecris Biotherapeutics, Inc., today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).

13 Apr 2010

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors.

From Baxter International Inc. 7 Apr 2010

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

1 Apr 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline. The two-year results were presented for the first time today at the Lysosomal Disease Network WORLD Symposium in Miami, Fla.

12 Feb 2010

GA²LEN and EAACI warn: Older antihistamines in OTC allergy medications may be hazardous

A joint GA²LEN /EAACI report to be published in "Allergy" and available online on 8 February reviews new data on the treatment of allergies with older antihistamines compared with newer, second-generation H1-antihistamines. The research was funded by GA²LEN, an EU-funded Network of Excellence.

10 Feb 2010