Angioedema News and Research

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Angioedema is the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues. It is very similar to urticaria, but urticaria, commonly known as hives, occurs in the upper dermis.

American Plasma Users Coalition awarded $40,000 advocacy grant from CSL Behring

CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations that help people who use plasma-derived or recombinant therapies to manage rare and serious medical disorders.

3 Dec 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

Swissmedic approves REVLIMID for treatment of myelodysplastic syndromes

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that REVLIMID (lenalidomide) has been granted approval by the Swiss agency for Therapeutic Products (Swissmedic) for use in patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality with or without additional cytogenic abnormalities.

21 Nov 2011

Dyax and Defiante decide to withdraw KALBITOR MAA filed with EMA

Dyax Corp. announced today an update on KALBITOR's international regulatory status.

14 Nov 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

DuoCort Pharma granted marketing authorization for adrenal insufficiency drug, Plenadren in Europe

The Swedish specialty pharma company, DuoCort Pharma, announced today that the European Commission has granted a European Marketing Authorisation for Plenadren (hydrocortisone, modified release tablet), an orphan drug for treatment of adrenal insufficiency in adults, bringing these patients their first pharmaceutical innovation in over 50 years.

7 Nov 2011

UCB to sponsor several key sets of Cimzia data on RA at ACR 2011 meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, is proud to sponsor several key sets of Cimzia (certolizumab pegol) data at the American College of Rheumatology's 2011 Annual Scientific Meeting in Chicago, November 5-9.

7 Nov 2011

Human Genome Sciences to present abstracts regarding BENLYSTA, SLE at ACR/ARHP meeting

Human Genome Sciences, Inc. announced today that several abstracts related to BENLYSTA (belimumab) and systemic lupus erythematosus will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011.

5 Nov 2011

AMAG reports third quarter total revenues of $17.6 million

AMAG Pharmaceuticals, Inc. today reported unaudited consolidated financial results for the third quarter ended September 30, 2011.

4 Nov 2011

UCB to present new data on Cimzia at ACG annual scientific meeting

UCB, a leading biopharmaceutical company at the forefront of immunology treatment and research, will present new data on Cimzia at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Washington D.C. from October 28 to November 2.

1 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

ViroPharma licenses worldwide rights from Intellect Neurosciences to OX1 for treatment of FA

ViroPharma Incorporated today announced the license of worldwide rights from Intellect Neurosciences, Inc. to its clinical stage drug candidate, OX1, being developed for the treatment of Friedreich's Ataxia (FA), a rare, hereditary, progressive neurodegenerative disease.

1 Oct 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Top-line data from Santarus' budesonide MMX extended use study on ulcerative colitis

Santarus, Inc., a specialty biopharmaceutical company, today announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis.

20 Sep 2011

ViroPharma expands securities repurchase program

ViroPharma Incorporated today announced that the company's Board of Directors has authorized the use of up to an additional $200 million to repurchase shares of its common stock and/or its 2% Senior Convertible Notes due 2017.

15 Sep 2011

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

ViroPharma Incorporated and Halozyme Therapeutics announced today that ViroPharma has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze in combination with Halozyme's Enhanze technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme, in subjects with hereditary angioedema.

14 Sep 2011

Lilly, Boehringer Ingelheim to present latest data from diabetes portfolio at 47th EASD meeting

Boehringer Ingelheim and Eli Lilly and Company will present the latest data from their diabetes portfolio at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal, September 12-16.

8 Sep 2011

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011