Atypical Hemolytic Uremic Syndrome News and Research

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Alexion Pharmaceuticals reports full year 2013 GAAP and non-GAAP financial results

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2013. For the three months ended December 31, 2013, Alexion Pharmaceuticals, Inc. ("Alexion" or the "Company") reported net product sales of Soliris® (eculizumab) of $441.9 million, compared to $320.5 million for the same period in 2012.

30 Jan 2014

Alexion's Soliris gets FDA orphan drug designation for DGF prevention in renal transplant patients

Alexion Pharmaceuticals today announced that the U.S. Food and Drug Administration has granted an orphan drug designation to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of delayed graft function in renal transplant patients.

21 Jan 2014

Omeros' OMS721 receives FDA orphan drug designation for prevention of TMAs

Omeros Corporation today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration for prevention of complement-mediated thrombotic microangiopathies.

18 Dec 2013

Omeros announces financial results for second quarter of 2013

Omeros Corporation, a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced its financial results for the second quarter of 2013.

12 Aug 2013

Alnylam presents new pre-clinical data of ALN-CC5 for treatment of complement-mediated diseases

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has presented new pre-clinical data with ALN-CC5, an RNAi therapeutic targeting complement component C5.

21 Jun 2013

Omeros gets regulatory clearance to begin Phase 1 clinical trial of OMS721

Omeros Corporation today announced that it has obtained regulatory clearance to start the Phase 1 clinical trial evaluating OMS721, the Company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program.

13 Jun 2013

Combined complement mutations affect individuals' risk of aHUS and prognosis

Certain gene mutations affect individuals' risk of developing a serious kidney condition, as well as their prognosis after being diagnosed with the disease, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

22 Feb 2013

EC extends therapeutic indication for Soliris to treat atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the European Commission (EC) has extended the therapeutic indication for Soliris® (eculizumab) to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).

29 Nov 2011

Almac collaborates with Alexion for packaging and distribution of Soliris during German E. coli outbreak

Almac, a leading provider of contract services to the global pharmaceutical and biotech industries, responded earlier this year to an urgent request from their client partner, Alexion Pharmaceuticals, Inc., a global biotechnology company, for packaging and distribution of Soliris (eculizumab) for patients with STEC-HUS during the E. coli outbreak in Germany earlier this year.

21 Nov 2011

Alexion third quarter total revenues increase to $204.0 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and nine months ended September 30, 2011.

20 Oct 2011

Alexion receives FDA approval for Soliris to treat atypical Hemolytic Uremic Syndrome

The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

26 Sep 2011

EMA CHMP adopts positive opinion for Soliris to treat atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the therapeutic indication for Soliris® (eculizumab) be extended to include the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS) in Europe.

23 Sep 2011

Alexion second quarter net product sales of Soliris increase to $185.7 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three and six months ended June 30, 2011. Alexion Pharmaceuticals, Inc. reported net product sales of Soliris of $185.7 million in Q2, reflecting steady addition of new patients, compared to $125.8 million for the same period in 2010.

21 Jul 2011

Final data from Alexion's Soliris Phase 2 studies on aHUS presented at EHA 2011

Alexion Pharmaceuticals, Inc. today announced the presentation of final data from the two Phase 2 studies of Soliris as a treatment for patients with atypical hemolytic uremic syndrome.

13 Jun 2011

Alexion's sBLA for Soliris receives FDA Priority Review designation to treat aHUS

Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted the Company's request for Priority Review of its supplemental Biologics License Application for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome.

1 Jun 2011

Alexion first quarter non-GAAP net income increases to $56.3 million

Alexion Pharmaceuticals, Inc. today announced financial results for the three months ended March 31, 2011. Alexion Pharmaceuticals, Inc. reported net product sales of Soliris® (eculizumab) of $166.1 million, reflecting steady additions of new patients, compared to $117.6 million for the same period in 2010.

21 Apr 2011

Alexion submits Soliris marketing applications to FDA, EMA for aHUS treatment

Alexion Pharmaceuticals, Inc. announced today that the company has submitted marketing applications to the U.S. Food and Drug Administration and the European Medicines Agency for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome.

7 Apr 2011

Genetic errors in women linked to increased risk of preeclampsia

Scientists have identified genetic errors in women with autoimmune diseases that increase the risk of preeclampsia, a potentially life-threatening condition that occurs in 10 percent of all pregnancies.

23 Mar 2011

Alexion joins EURORDIS, NORD and medical communities to observe Rare Disease Day 2011

Alexion Pharmaceuticals, Inc. joins the European Organization for Rare Diseases, the National Organization for Rare Disorders and families, governments, companies and medical communities around the world in observing the fourth annual Rare Disease Day today.

28 Feb 2011

Alexion fourth quarter net product sales of Soliris increases to $156.0 million

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter and year ended December 31, 2010. For the three months ended December 31, 2010, Alexion Pharmaceuticals, Inc. reported net product sales of Soliris® (eculizumab) of $156.0 million, reflecting strong additions of new patients, compared to $110.6 million for the same period in 2009.

10 Feb 2011