HAE in the News
The articles listed below are various press releases on Hereditary Angioedema
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4 5 6 7 8 9 10 FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary AngioedemaFeb 4, 2009 - investor.dyax.com
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Advisory Committee voted (6 yes, 5 no, 2 abstentions) in favor of approval of DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE). If approved, DX-88 will be the first drug available in the U.S. for treating acute attacks of HAE and the first subcutaneously administered HAE therapy. HAE is a rare, potentially fatal genetic disorder characterized by spontaneous episodes of severe, debilitating and often painful swelling. The Committee’s findings will be weighed by the FDA in determining whether DX-88 is to be approved for marketing. ...
moreFDA cites allergic reactions with Dyax drugFeb 3, 2009 - www.forbes.com
Federal health officials said Monday that studies by Dyax Corp. do not give a definitive picture of the effectiveness of its drug to treat a rare swelling condition.
In a review posted online, the Food and Drug Administration also voiced concerns about severe allergic reactions seen in patients injected with the medication.
...
moreViroPharma drug gets FDA priority reviewFeb 3, 2009 - www.forbes.com
ViroPharma Inc. said Tuesday the Food and Drug Administration granted its protein deficiency drug candidate Cinryze priority review.
The FDA designation means the review will be targeted within six months instead of the standard 10 months. Drug candidates are given priority review because they are aimed at conditions for which treatments are lacking. ...
moreDyax (DYAX) Said FDA Advisory Committee to Review DX-88Jan 13, 2009 - http://www.streetinsider.com
Dyax Corp. (NASDAQ: DYAX) said the FDA'S Pulmonary-Allergy Drugs Advisory Committee is scheduled to discuss the Company's Biologics License Application for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema on February 4, 2009 ...
moreMoyock student has rare diseaseJan 3, 2009 - www.dailyadvance.com
Being a middle schooler can be challenging enough. But for 12-year-old Colby Clements, the challenge also includes having a rare disease that keeps him at the hospital a lot.
“(The disease) has drastically affected our lives,” says his mother, Dana Richardson. “We are in and out of hospitals for three to five days at a time several times a month. Colby is missing a lot of school days.” ...
moreMedical Mystery Solved In North AttleboroDec 16, 2008 - www.thebostonchannel.com
From the age of 7, a local woman suffered from a condition that nearly killed her as an adult.
As News Center 5's Heather Unruh reported Tuesday, it took doctors more than three decades to reach a diagnosis. ...
moreUW Milk Study for Kidney Transplant not CheesyDec 3, 2008 - transplantviews.blogspot.com
...researchers will be looking into whether milk produced by genetically engineered cows can prevent the rejection of transplanted kidneys.... ...
moreViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary AngioedemaDec 1, 2008 - biz.yahoo.com
ViroPharma Incorporated (Nasdaq: VPHM - News) today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze(TM) C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE). ...
moreDyax drug candidate for genetic disorder gets 6-month priority review by FDANov 21, 2008 - money,cnn.com
Dyax Corp. said Friday the Food and Drug Administration is giving priority review to the biotechnology company's developing treatment for a genetic condition that can lead to dangerous swelling.
The agency will aim to review the application for the drug within six months. An action date is set for March 23 ...
moreCinryze(TM) Receives FDA Approval for Prophylaxis Against Hereditary Angioedema AttacksOct 10, 2008 - biz.yahoo.com
NEW YORK--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB - News) today announced that the U.S. Food and Drug Administration (FDA) approved Cinryze™ (C1 inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze is expected to be commercially available for prophylaxis against HAE later this year. ...
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The US Hereditary Angioedema Assoc.,
Seven Waterfront Plaza,
500 Ala Moana Blvd., Suite 400,
Honolulu, HI 96813, (866) 798-5598