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.

Journal of Rheumatology publishes positive results from Cimzia Phase III trial in RA

UCB announced today results from a post hoc analysis of the RAPID 1 study published in the Journal of Rheumatology. The results suggest moderate to severe rheumatoid arthritis patients treated with Cimzia, the only approved PEGylated anti-TNF, together with methotrexate, achieved a rapid response associated with improved long-term outcomes one year after treatment began.

11 May 2011

Santarus' budesonide MMX Phase III data in ulcerative colitis to be presented at DDW 2011

Santarus, Inc. today announced that the budesonide MMX Phase III clinical program will be featured in two oral presentations at the Digestive Disease Week Meeting being held at McCormick Place in Chicago on May 7-10, 2011.

3 May 2011

ViroPharma reports net sales of $127 million for first quarter 2011

ViroPharma Incorporated reported today its financial results for the first quarter ended March 31, 2011.

28 Apr 2011

Thought leaders gather to examine challenges facing patients with primary immunodeficiencies

Thought leaders from the medical, scientific and patient advocacy communities gathered in New York and London for CSL Behring's Key Issues Dialogue–Immunoglobulin to examine challenges facing patients with primary immunodeficiencies.

21 Apr 2011

Merck enters definitive agreement to acquire Inspire

Merck, known as MSD outside the United States and Canada, and Inspire Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement under which Merck will acquire Inspire, a specialty pharmaceutical company focused on developing and commercializing ophthalmic products.

6 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

ViroPharma presents Cinryze data against HAE at AAAAI Annual Meeting

ViroPharma Incorporated today announced data presented in two poster presentations relating to Cinryze at the 2011 American Academy of Allergy Asthma & Immunology Annual Meeting, March 18 through 22, in San Francisco, CA.

23 Mar 2011

Astellas announces positive results from mirabegron phase III trials against OAB

Astellas Pharma Inc. today announced the results of two pivotal phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder, show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition.

23 Mar 2011

ViroPharma launches online community for teens and adults with hereditary angioedema

ViroPharma Incorporated today announced the launch of "HAE and Me," an online community that unites teens and adults with hereditary angioedema (HAE) through shared experiences to help them better manage their disease.

21 Mar 2011

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.

21 Mar 2011

CHMP recommends approval of Centralized Marketing Authorization for Cinryze

ViroPharma Incorporated today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.

19 Mar 2011

Santarus commences SAN-300 Phase I clinical study to treat inflammatory diseases

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Shire receives European Commission approval for self-administration of FIRAZYR for HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II hereditary angioedema (HAE) attacks licensed for self-administration in Europe.

4 Mar 2011

RMEI, PIM sponsor medical education monograph on HAE

Hereditary angioedema is an autosomal dominant disorder resulting from a deficiency in functional C1 inhibitor. Manifestations include recurrent episodes of nonpitting subcutaneous and submucosal edema involving the skin, airway, and visceral organs.

2 Mar 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 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, 2010.

25 Feb 2011

FDA approves sBLA for CSL's Hizentra to treat PI

CSL Behring announced today that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 24 months to 30 months.

24 Feb 2011

Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema.

22 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-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. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011