HAE in the News

The articles listed below are various press releases on Hereditary Angioedema

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Dyax drug submitted to FDA
Dyax Corp. has completed its application for federal regulatory approval for a new hereditary angioedema treatment. The Cambridge, Mass-based company (Nasdaq: DYAX) is hoping the U.S. Food and Drug Administration will grant priority review to the drug, known as DX-88. The status is for drugs that target an unmet medical need, and would place the FDA on a six-month time frame to take action on the application. ...more


UPDATE 1-Pharming says Rhucin data addresses concerns
AMSTERDAM, Sept 22 (Reuters) - Dutch biotechnology company Pharming (PHAR.AS: Quote, Profile, Research, Stock Buzz) said on Monday progress in developing its key Rhucin drug meant it was now able to address concerns raised by regulatory authorities earlier this year. ...more


Where in the world will George Plaster pop up next?
Popular sportscaster George Plaster gets around — boy, does he. He's been held by Jessica Simpson, clutched to the bosom of Dolly Parton and wrapped up in an American Girl scarf. He's been spotted at Yankee Stadium, Wrigley Field, Bristol Motor Speedway, and wearing a Cheesehead hat in Green Bay. ...more


Dyax to Finish Rolling BLA for Angioedema Drug This Fall
Dyax will complete its BLA submission for its DX-88 investigational treatment for hereditary angioedema early in the fourth quarter, based on positive results from a second Phase III trial.

The firm initiated the rolling BLA for DX-88 (ecallantide) late last year. Results from the trial will complete the application, the company said. The product is designated as an orphan drug, and the company will ask the FDA for a priority review. ...more


Dyax Announces DX-88 for Hereditary Angioedema Meets Primary and Secondary Endpoints in Phase 3 Trial (EDEMA4®)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today positive topline results from its second Phase 3, placebo-controlled trial, EDEMA4, for its lead product candidate DX-88 (ecallantide) for hereditary angioedema (HAE). The EDEMA4 trial, conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA), achieved statistically significant improvements in the intent-to-treat population in primary and secondary endpoints. DX-88 was also found to be well tolerated with no drug-related serious adverse events reported in the EDEMA4 trial. Based on the safety and efficacy results from its EDEMA4 and EDEMA3 Phase 3 trials, Dyax intends to submit the last module of its Biologics License Application (BLA) to the FDA early in the fourth quarter of 2008. ...more


InvestSource Inc.: Lev Pharmaceuticals Acquired by ViroPharma
Lev Pharmaceuticals, Inc. (OTC BB: LEVP | Quote | Chart | News | PowerRating) and ViroPharma Incorporated today announced that the companies have signed a definitive merger agreement under which ViroPharma will acquire Lev, a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases, for $442.9 million of upfront consideration, or $2.75 per Lev share, comprised of $2.25 per share in cash and $0.50 per share in ViroPharma common stock (subject to a collar). ...more


Jerini Receives European Commission Approval for FIRAZYR(R) (Icatibant) in the Treatment of HAE
BASINGSTOKE, England and CAMBRIDGE, Massachusetts, July 15 – Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, notes that Jerini AG (FSE:JI4) has announced today that the European Commission has granted the company marketing authorization for its lead compound FIRAZYR(R) (Icatibant) in the treatment of acute attacks of hereditary angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic disease characterized by spontaneous and recurring attacks of edema. ...more


Pharming says ongoing open-label studies with Rhucin show positive results
Biotech company Pharming Group N.V. said that its ongoing open-label studies with lead product Rhucin are showing positive results. ...more


Shire Buys Germany's Jerini to Add Rare Disease Drug
uly 3 (Bloomberg) -- Shire Ltd., the U.K.'s third-biggest drugmaker, agreed to pay 349 million euros ($554 million) in cash for Germany's Jerini AG to add a treatment for a sometimes fatal tissue swelling. ...more


Lev to file application for approval of angioedema drug
Pharmaceuticals has entered into a letter agreement with the Sanquin Blood Supply Foundation, authorizing Lev to file for European marketing authorization of its lead product candidate, Cinryze, for the treatment of hereditary angioedema, also known as C1 inhibitor deficiency. ...more


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