HAE in the News

The articles listed below are various press releases on Hereditary Angioedema

---

Page#: 1  2  3  4  5  6  7  8  9  10 


Pharming plans submission Rhucin BLA to US FDA end 2010
Leiden, Netherlands, Aug 25, 2010 (Thomson Reuters ONE via COMTEX) -- Leiden, The Netherlands, August 25, 2010. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin(R) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Following pre-BLA discussions with the FDA, Pharming is preparing the BLA dossier for submission towards the end of this year but no later than January 2011. ...more


Data from First Phase 3 Trial (EDEMA3(R)) for KALBITOR(R) (ecallantide) Published in The New England Journal of Medicine
CAMBRIDGE, Mass., Aug 05, 2010 (BUSINESS WIRE) -- Dyax Corp. (NASDAQ: DYAX) announced today that results from EDEMA3(R), the Company's first Phase 3 trial evaluating KALBITOR(R) (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), were published in the August issue of TheNew England Journal of Medicine. KALBITOR, discovered and developed by Dyax, is available in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. ...more


ViroPharma Announces Publication of Cinryze(TM) (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
EXTON, Pa., Aug 05, 2010 /PRNewswire via COMTEX/ --ViroPharma Incorporated (Nasdaq: VPHM) today announced that data from Phase 3 studies of Cinryze(TM) (C1 esterase inhibitor [human]) have been published in the August 5, 2010 issue of the New England Journal of Medicine. The paper entitled Nanofiltered C1 Inhibitor Concentrate for Treatment of Hereditary Angioedema by Dr. Bruce L. Zuraw et al. describes the safety and efficacy of Cinryze in treating and preventing attacks of hereditary angioedema. Cinryze is the first and only FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease; it is not approved by the FDA to treat acute angioedema attacks. ...more


Study Published in the New England Journal of Medicine Demonstrates Efficacy and Favourable Safety Profile of Firazyr® (Icatibant) for the Treatment of Hereditary Angioedema (HAE) Attacks
DUBLIN, Ireland – August 4th – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced the publication of results from two Phase III studies of FIRAZYR® (icatibant) in the August 5th issue of the New England Journal of Medicine. The studies, FAST-1 and FAST-2 (For Angioedema Subcutaneous Treatment), were designed to evaluate the effect of icatibant in adult patients with Type 1 or Type 2 hereditary angioedema (HAE) presenting with cutaneous and/or abdominal attacks. ...more


CSL’s Berinert cited in NEJM Editorial
Patients with hereditary angioedema suffer from acute attacks of subcutaneous and submucosal swelling. This autosomal dominant disorder is caused by mutations in the C1 esterase inhibitor gene that result in low levels of C1 inhibitor or normal levels with reduced function. C1 inhibitor is important for regulating the coagulation, complement, and contact cascades; in hereditary angioedema, all three cascades appear to be dysregulated. Bradykinin, a potent vasodilator activated through the contact cascade, is a key mediator; excess bradykinin increases capillary endothelial permeability and leads to localized swelling. The resulting edema is painful and can be life-threatening when it causes obstruction of the upper airways. ...more


Dyax Features Comprehensive Financial Assistance Program On Enhanced Product Website for KALBITOR(R) (ecallantide)
CAMBRIDGE, Mass., Jul 19, 2010 (BUSINESS WIRE) -- Dyax Corp. (NASDAQ:DYAX) today announced that it has launched its newly enhanced product website, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.KALBITOR.com&esheet=6363207&lan=en-US&anchor=www.KALBITOR.com&index=3&md5=daf9eacd6f4f7439a22b3620141c703c, featuring its comprehensive financial assistance program. KALBITOR(R) (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. ...more


Dyax and Sigma-Tau Announce Partnership to Develop and CommercializeSubcutaneous DX-88 (ecallantide) for Hereditary Angioedema and Other Indications in Europe, North Africa, Middle East and Russia
CAMBRIDGE, Mass., Jun 21, 2010 (BUSINESS WIRE) --Dyax Corp. (NASDAQ: DYAX) and Defiante Farmaceutica S.A., a subsidiary of the pharmaceutical company Sigma-Tau SpA (Sigma-Tau), announced today a strategic partnership to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia. Dyax retains its rights to subcutaneous DX-88 in other territories, including the U.S., where DX-88 has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR(R) (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older. ...more


ViroPharma Files Prior Approval Supplement (PAS) for Cinryze(TM) (C1 Esterase Inhibitor [Human]) Industrial Scale Manufacturing
EXTON, Pa., June 21, 2010 /PRNewswire via COMTEX/ --ViroPharma Incorporated (Nasdaq: VPHM) today provided an update on recent progress in Cinryze(TM) (C1 Esterase Inhibitor [Human]) manufacturing expansion activities. ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts. The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE. The addition of the industrial scale project is expected to significantly increase capacity for Cinryze, providing adequate supply to meet the company's projected demand growth for prophylaxis against attacks of HAE. ...more


CSL Behring Receives Canadian Notice of Compliance for Berinert®
CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity. HAE is a rare and serious genetic disorder. ...more


KALBITOR® (ecallantide) Now Commercially Available
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today that KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older is now commercially available in the United States. ...more


Page #: 1  2  3  4  5  6  7  8  9  10 

The US Hereditary Angioedema Assoc., Seven Waterfront Plaza, 500 Ala Moana Blvd., Suite 400, Honolulu, HI 96813, (866) 798-5598

The US HAEA's 2010 corporate sponsors