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.

CSL Behring rIX-FP granted Orphan Drug Designation to treat hemophilia B

CSL Behring announced today that the company has been granted Orphan Drug Designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).

8 Jun 2012

ViroPharma initiates maribavir Phase 2 program for CMV infections

ViroPharma Incorporated today announced the initiation of a Phase 2 program to evaluate maribavir for the treatment of cytomegalovirus infections in transplant recipients.

4 Jun 2012

FDA accepts CSL Behring’s 4-factor PCC BLA for standard review

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

30 May 2012

Bayer’s Nexavar Phase 3 trial on NSCLC does not meet primary endpoint

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.

22 May 2012

Santarus to present UCERIS Phase III trial data on ulcerative colitis at DDW meeting

Santarus, Inc. today announced that safety and efficacy data from a Phase III, double-blind, multicenter, placebo-controlled 12 month extended use study with the investigational drug UCERIS (budesonide) 6 mg tablets will be featured in four poster presentations at the Digestive Disease Week (DDW) Meeting being held at the San Diego Convention Center on May 19 - 22, 2012.

19 May 2012

Pfizer announces results from Lyrica clinical studies on fibromyalgia

Pfizer Inc. announced the results of studies on Lyrica (pregabalin) capsules CV presented at the American Pain Society Annual Meeting in Honolulu.

19 May 2012

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy.

18 May 2012

Dyax introduces free Attack Tracker smartphone application for hereditary angioedema patients

Dyax Corp. today announced the launch of a free smartphone application for the iPhone - HAE Attack Tracker. This application allows HAE patients to keep detailed records of their disease related information, including emergency and physician contacts as well as individual attack data.

11 May 2012

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that results from three phase III studies evaluating the use of continuous REVLIMID(lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine.

11 May 2012

Sunovion announces results from LATUDA open-label study for schizophrenia

Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.

10 May 2012

Halozyme first quarter net loss increases to $15.1 million

Halozyme Therapeutics, Inc. today reported financial results for the quarter ended March 31, 2012.

8 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012

BioCryst first quarter revenues increase to $12.2 million

BioCryst Pharmaceuticals, Inc. announced financial results for the first quarter ended March 31, 2012.

7 May 2012

Pfizer terminates Lyrica Phase 3 trial on neuropathic pain associated with HIV neuropathy

Pfizer Inc. announced today that it has stopped a Phase 3 clinical trial of Lyrica (pregabalin) in patients with neuropathic pain associated with HIV neuropathy, a form of nerve damage characterized by burning pain usually beginning in the feet. The decision follows review of a planned interim analysis of the study by the trial's external Data Monitoring Committee.

5 May 2012

Pfizer’s Lyrica Phase 3 study on pDPN fails to meet primary endpoint

Pfizer Inc. announced today that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy (pDPN) did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline.

5 May 2012

CSL Behring commences C1-INH phase I/II study in hereditary angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema.

4 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

CSL Behring commits donations to World Federation of Hemophilia GAP program

To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of Hemophilia (WFH) Global Alliance for Progress (GAP) program over the period of three years, beginning in 2012. The product donations will be made with medicine having a minimum shelf-life of one year.

17 Apr 2012

Purdue Pharma launches Intermezzo for middle-of-the-night insomnia

Purdue Pharma L.P. announced today that Intermezzo (zolpidem tartrate) sublingual tablet CIV is now available in 1.75 mg and 3.5 mg dosage strengths by prescription in retail pharmacies nationwide.

6 Apr 2012

Dyax, GE Healthcare partner to develop and commercialize c-Met imaging peptides

GE Healthcare, a unit of GE, and Dyax Corp. today announced a licensing agreement for the development and commercialization of peptides binding to c-Met, which provides upfront, milestone, and royalty payments to Dyax.

2 Apr 2012