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Tag: orphan
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