Hereditary Angioedema News and Research

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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

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

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

Defiante, Dyax expand KALBITOR partnership to treat hereditary angioedema

Dyax Corp. and Defiante Farmaceutica S.A., an affiliate of the pharmaceutical group Sigma-Tau, announced today an expansion of their strategic partnership for KALBITOR in the treatment of hereditary angioedema and other therapeutic indications to include development and commercialization rights in Latin America, excluding Mexico and the Caribbean, Taiwan, Singapore and South Korea.

31 May 2011

ViroPharma launches documentary film on hereditary angioedema

ViroPharma Incorporated today announced the launch of the documentary Swell, a twenty-five minute film that allows families dealing with the rare genetic swelling disease, hereditary angioedema, to share the challenges and triumphs of living with a chronic disorder.

27 May 2011

New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

Santarus, Inc., a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema were presented at the 7th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.

23 May 2011

ViroPharma, Halozyme sign license deal to develop Cinryze against hereditary angioedema

Halozyme Therapeutics, Inc. and ViroPharma Incorporated, today announced the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 in the development of a subcutaneous formulation of Cinryze .

12 May 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

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

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

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

CSL Behring receives marketing approval for HAE drug Berinert in Israel

CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

28 Jan 2011

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Shire reports topline results from FAST-3 Firazyr Phase III trials for acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).

2 Dec 2010