United Therapeutics Announces Agreement To Acquire Priority Review Voucher
Voucher expected to be applied to the forthcoming NDA for Tyvaso DPI™
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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2020 /PRNewswire/ United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
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Full article The US company behind the pig is United Therapeutics Corporation. It plans to develop medical products, such as blood thinners, that will not cause allergic reactions
The United States Food and Drug Administration (FDA) has approved a genetically modified pig to be used as food and for medical products.
The pig is genetically engineered to remove a sugar found on the surface of cells in many animals. The sugar, called alpha-gal, can cause allergy reactions in some people. The substance is used in many products, including medicines, food and cosmetics.
The US company behind the pig is United Therapeutics Corporation. It plans to develop medical products, such as blood thinners, that will not cause allergic reactions, company spokesman Dewey Steadman said.
US Approves Genetically Changed Pig for Food and Medicine voanews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from voanews.com Daily Mail and Mail on Sunday newspapers.
The U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses.
The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb).