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 Baxter's GAMMAGARD LIQUID for multifocal motor neuropathy

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] as a treatment for multifocal motor neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the United States, and it was approved for use with MMN patients in Europe in 2011.

From Baxter International Inc. 25 Jun 2012

EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

23 Jun 2012

Psoriasis link with autoimmune diseases underscored

Patients with psoriasis are nearly twice as likely to have an autoimmune disease as individuals without the condition, suggest study findings.

8 Jun 2012

Chinese sFDA approves Baxter's ADVATE to treat hemophilia A

Baxter International Inc. today announced the approval of ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration.

From Baxter International Inc. 17 May 2012

Otsuka announces results from aripiprazole Phase 3 trial on schizophrenia

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.

8 May 2012

FDA approves Protalix, Pfizer’s ELELYSO for treatment of type 1 Gaucher disease

Pfizer Inc. and Protalix BioTherapeutics, Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease.

2 May 2012

EMA CHMP recommends approval of AMAG’s ferumoxytol

AMAG Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

21 Apr 2012

New ACR guidelines recommend use of topical NSAIDs for older patients with knee OA

The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

31 Mar 2012

CSL Behring initiates FCH Phase III trial to control bleeding during cardiovascular surgery

CSL Behring announced today that the first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of fibrinogen concentrate (Human) (FCH) in controlling microvascular bleeding during aortic aneurysm surgery.

16 Mar 2012

Shire to commence two Vyvanse and Concerta Phase 4 comparison trials for ADHD

As part of its continued commitment to ADHD research, Shire plc, the global specialty biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta (methylphenidate HCl) Extended-Release Tablets.

7 Mar 2012

AMAG fourth quarter total revenues decrease to $14.9 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2011. As of December 31, 2011, the company's cash, cash equivalents and investments totaled approximately $230 million.

5 Mar 2012

Valeant receives FDA approval for secondary supplier of Methoxsalen

The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg.

15 Feb 2012

Genzyme announces four-year data from eliglustat tartrate phase 2 trial on Gaucher disease type 1

Genzyme, a Sanofi company, announced today four-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.

8 Feb 2012

AMAG completes enrollment in Feraheme Phase III program for iron-deficiency anemia

AMAG Pharmaceuticals, Inc. today announced the completion of patient enrollment in the second of the company's two phase III studies that comprise its global registrational program for Feraheme (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause.

30 Jan 2012

Baxter to commence second GAMMAGARD LIQUID Phase III trial in Alzheimer's

Baxter International Inc. today provided an update on its clinical program evaluating the use of its GAMMAGARD LIQUID 10%, for the treatment of mild to moderate Alzheimer's disease.

From Baxter International Inc. 24 Jan 2012

Baxter submits GAMMAGARD LIQUID sBLA to FDA for treatment of MMN

Baxter International Inc. today announced that the company has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of GAMMAGARD LIQUID 10% for the treatment of multifocal motor neuropathy.

From Baxter International Inc. 9 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

UCB initiates EXXELERATE study in rheumatoid arthritis

UCB today announced the start of the EXXELERATE study which will evaluate the short- and long-term efficacy of Cimzia (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira(adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.

21 Dec 2011

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

Feraheme as safe and effective as iron sucrose in patients with anemia, CKD

AMAG Pharmaceuticals, Inc. today announced positive new data from the FIRST head-to-head trial comparing Feraheme (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease.

14 Nov 2011