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.

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

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