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.

Firazyr receives FDA approval for treatment of HAE acute attacks

The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

26 Aug 2011

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

26 Aug 2011

Santarus, Depomed enter new commercialization agreement for GLUMETZA

Santarus, Inc. and Depomed, Inc. today announced that they have entered into a new commercialization agreement for GLUMETZA (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008.

23 Aug 2011

Dyax initiates ecallantide Phase 2 trial for ACE inhibitor-induced angioedema

Dyax Corp. announced today treatment of the first patient in a Phase 2 trial evaluating the efficacy and safety of ecallantide, a potent, selective, reversible inhibitor of plasma kallikrein, for acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema.

4 Aug 2011

BioCryst second quarter total revenues decrease to $3.7 million

BioCryst Pharmaceuticals, Inc. announced financial results for the second quarter and six months ended June 30, 2011.

4 Aug 2011

Pharming, Santarus reach SPA agreement with FDA for RHUCIN Phase III trial

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application.

4 Aug 2011

Kadmon, Dyax enter license agreement for antibody phage display libraries

Dyax Corp. and Kadmon Corporation, LLC announced today that Dyax has granted Kadmon a non-exclusive license to Dyax's proprietary "gold-standard" antibody phage display libraries for the discovery and development of therapeutic antibodies.

26 Jul 2011

AMAG enters definitive merger agreement with Allos Therapeutics

AMAG Pharmaceuticals, Inc. and Allos Therapeutics, Inc. today announced that they have entered into a definitive merger agreement under which the companies will combine in an all-stock merger with a total equity value of approximately $686 million.

21 Jul 2011

CSL Behring supports World Federation of Hemophilia with 1 million IUs of von Willebrand factor/Factor VIII

CSL Behring has donated more than 1 million international units (IU) of von Willebrand factor (VWF)/Factor VIII (FVIII) replacement medication to patients through the World Federation of Hemophilia (WFH). The donation supports WFH's progress in improving the diagnosis and treatment of bleeding disorders in developing countries through its Global Alliance for Progress (GAP) program.

18 Jul 2011

iBio successfully produces human plasma proteins using proprietary technology

iBio, Inc. today announced successful production of human plasma proteins using its proprietary iBioLaunch technology. Human alpha 1-antitrypsin and human C1 esterase inhibitor were successfully produced at high yield in green plants via the Company's proprietary iBioLaunch technology. Both of these proteins are important therapeutic products, but until now they have been made from human blood.

11 Jul 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

In a new post-hoc analysis based on the American Association of Clinical Endocrinologists (AACE/ACE) diabetes algorithm presented at the American Diabetes Association (ADA) 71st Annual Scientific Sessions, significantly more patients with type 2 diabetes treated with JANUMET-tablets achieved blood sugar goals after 18 weeks compared to metformin as initial therapy.

27 Jun 2011

ViroPharma receives positive European CHMP opinion for Buccolam to treat acute seizures

ViroPharma Incorporated today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization (PUMA) for Buccolam, for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years.

24 Jun 2011

Pfizer Lyrica Phase 3 study on Central Neuropathic Pain meets primary endpoint

Pfizer Inc. announced today that top-line results for Lyrica Study A0081107 - Central Neuropathic Pain Following Spinal Cord Injury - demonstrated that the study met its primary endpoint: positive efficacy in reducing Central Neuropathic Pain following Spinal Cord Injury with Lyrica compared to placebo.

22 Jun 2011

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene International Sàrl announced that clinical data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, TX, evaluating the combination regimen of REVLIMID plus rituximab (R2) in untreated, advanced stage, indolent B-cell non-Hodgkin's lymphomas, were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

18 Jun 2011

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

Groupe d'Etude des Lymphomes de l'Adulte (GELA) and Celgene International Sarl today announced a collaboration to conduct an international randomized study to evaluate the therapeutic potential of the REVLIMID/rituximab combination regimen (R2) in patients with newly diagnosed follicular lymphoma.

17 Jun 2011

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

Celgene International Sàrl announced that clinical data from two studies evaluating the use of REVLIMID® (lenalidomide) with standard R-CHOP chemotherapy in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.

17 Jun 2011

ViroPharma receives European Centralized Marketing Authorization for Cinryze for treatment of HAE

ViroPharma Incorporated today announced that the European Commission has granted ViroPharma Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.

16 Jun 2011

Cinryze data on hereditary angioedema presented at EAACI 2011

ViroPharma Incorporated today announced that data relating to Cinryze from nine accepted abstracts were presented as poster presentations at the 30th Congress of the European Academy of Allergy and Clinical Immunology (EAACI), June 11 through 15, in Istanbul, Turkey.

14 Jun 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

6 Jun 2011

Angioedema News and Research

Further Reading

Firazyr receives FDA approval for treatment of HAE acute attacks

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Santarus, Depomed enter new commercialization agreement for GLUMETZA

Dyax initiates ecallantide Phase 2 trial for ACE inhibitor-induced angioedema

BioCryst second quarter total revenues decrease to $3.7 million

Pharming, Santarus reach SPA agreement with FDA for RHUCIN Phase III trial

Kadmon, Dyax enter license agreement for antibody phage display libraries

AMAG enters definitive merger agreement with Allos Therapeutics

CSL Behring supports World Federation of Hemophilia with 1 million IUs of von Willebrand factor/Factor VIII

iBio successfully produces human plasma proteins using proprietary technology

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

New data from JANUMET clinical study on type 2 diabetes presented at ADA 2011

ViroPharma receives positive European CHMP opinion for Buccolam to treat acute seizures

Pfizer Lyrica Phase 3 study on Central Neuropathic Pain meets primary endpoint

Celgene announces data from REVLIMID plus rituximab Phase II study on malignant lymphomas

Celgene, GELA to conduct REVLIMID/rituximab combination study on newly diagnosed FL

REVLIMID-R-CHOP Phase I/II data in untreated DLBCL presented at malignant lymphoma conference

ViroPharma receives European Centralized Marketing Authorization for Cinryze for treatment of HAE

Cinryze data on hereditary angioedema presented at EAACI 2011

Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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