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Hansa Medical receives FDA Orphan Drug Designation for IdeS

2015-09-15 06:06:51| Appliances - Topix.net

Hansa Medical today announced that the U.S. Food and Drug Administration has granted orphan drug designation to IdeS for the prevention of antibody mediated organ rejection in solid organ transplant patients. More information about the ODD has been posted on www.fda.com Approximately 30 percent of the patients on the waiting lists for kidney, heart, lung and pancreas, equivalent to approximately 35 000 patients in the US, are sensitized to Human Leukocyte Antigen .

Tags: medical drug receives designation

 

Product Launch - Diageo's Orphan Barrel Rhetoric 21-Year-Old Kentucky Straight Bourbon

2015-08-03 18:46:00| Daily beverage news and comment - from just-drinks.com

Diageo's Bourbon unit Orphan Barrel Whiskey Distilling Company has released a 21-year-old expression in its Rhetoric series.

Tags: product straight launch kentucky

 
 

Premarket Biotech Digest: Novartis Earnings, Portola Lawsuits, Celgene's Orphan Drug

2015-07-23 11:13:42| Biotech - Topix.net

Xarelto, Eliquis and other anticoagulants that face products liability lawsuits have made deals with Portola, which is developing an antidote. One of the first anticoagulants, warfarin, was used as rat poison for 50 years before it began life as a blood thinner - and the only reason it did that was because a US Army sergeant who tried to kill himself with it was cured when treated with Vitamin K. Moral of the story- if you want to develop an anticoagulant, you better also develop its antidote, or you could bungle your way into multiple lawsuits.

Tags: drug earnings digest biotech

 

Swedish Orphan in Talks for Partner on Hemophilia Gene Therapy

2015-07-16 19:47:33| Appliances - Topix.net

Swedish Orphan Biovitrum AB, a maker of hemophilia treatments, is in discussions with potential partners on developing a gene therapy for the blood-clotting disorder. The company, known as Sobi, may enter the race to develop a therapy that would fix the genetic defect that causes hemophilia, which would threaten sales of products designed to prevent bleeding.

Tags: partner therapy gene talks

 

Akcea Therapeutics obtains FDA Orphan Drug Designation for volanesorsen

2015-07-06 15:29:07| Biotech - Topix.net

Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, Inc. , announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome . FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis.

Tags: drug designation fda obtains

 

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