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Latest ATryn Stories

2008-10-06 09:00:57

OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn(R) (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC Biotherapeutics, allowing the company to develop and commercialize the product in this country. The acceptance of the BLA comes just one month after the FDA assigned a priority review to the product, which has also been granted...

2008-09-19 06:00:09

By Elizabeth Weise After more than seven years of discussion, the Food and Drug Administration proposed regulations Thursday that would allow the commercial use of genetically engineered animals. Such animals are genetically altered -- either their genes are changed or genes from another animal are added -- for a specific purpose. The FDA states that such animals either produce drugs; serve as models for human disease; produce industrial or consumer products, such as fiber; or have...

2008-09-05 09:00:37

GTC Biotherapeutics, a developer of recombinant blood proteins, has announced that the FDA has assigned priority review to the company's biologic license application for ATryn. Priority review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under priority review, the FDA's target date for action on the biologic license...

2008-09-04 09:00:48

The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s ("GTC", Nasdaq: GTCB) Biologic License Application, or BLA, for ATryn(R). Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA's target date for action on the BLA is February 7, 2009....

2008-08-14 09:01:15

GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced the closing of its previously announced collaboration agreement with OVATION Pharmaceuticals, Inc. ("OVATION") to develop and market ATryn(R) in the United States. ATryn(R) is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The agreement includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones, including a $3 million...

2008-08-14 09:01:14

OVATION Pharmaceuticals, Inc. announced today that it has completed its previously announced transaction to obtain the exclusive license for the commercialization and development of GTC Biotherapeutics' ATryn(R) (antithrombin alfa) in the United States. Last week, GTC completed its Biologics License Application (BLA) submission requesting market authorization for the use of ATryn(R) in the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with...

2008-08-07 15:01:00

GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn(R) in the United States. The final portion of the BLA submission includes all of the clinical safety and efficacy data generated from studies of ATryn(R), including the pivotal study supporting product licensure. ATryn(R) is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties....

2008-08-07 09:01:06

GTC Biotherapeutics, Inc.'s ("GTC", Nasdaq: GTCB) total net loss for the second quarter ended June 29, 2008, was $2.2 million, or $0.02 per share, compared with a net loss of $10.6 million, or $0.14 per share, for the second quarter of 2007. The total net loss for the first six months of 2008 was $10.4 million, or $0.11 per share, compared to $18.1 million, or $0.23 per share, for the first six months of 2007. "We have had an excellent quarter, achieving strong cash receipts from our...

2006-06-02 08:15:00

By Ben Hirschler, European Pharmaceuticals Correspondent LONDON -- The world's first medicine derived from a genetically engineered animal has been recommended for approval by a panel of European experts, following a re-examination of the evidence. The European Medicines Agency initially rejected ATryn, an anti-clotting agent for people with a rare inherited disease which is made from the milk of transgenic goats. But the agency's Committee for Medicinal Products for Human Use (CHMP) said it...

2006-06-02 08:00:00

By Ben Hirschler, European Pharmaceuticals Correspondent LONDON (Reuters) - The world's first medicine derived from a genetically engineered animal has been recommended for approval by a panel of European experts, following a re-examination of the evidence. The European Medicines Agency initially rejected ATryn, an anti-clotting agent for people with a rare inherited disease which is made from the milk of transgenic goats. But the agency's Committee for Medicinal Products for Human Use (CHMP)...


Word of the Day
lambent
  • Licking.
  • Hence Running along or over a surface, as if in the act of licking; flowing over or along; lapping or bathing; softly bright; gleaming.
This word comes the Latin 'lambere,' to lick.
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