Acquired Hemophilia News and Research

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Baxter seeks FDA approval of OBI-1 for adults with acquired hemophilia A

Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of OBI-1, a recombinant antihemophilic porcine sequence factor VIII, in patients with acquired hemophilia A.

From Baxter International Inc. 11 Dec 2013

Inspiration, Ipsen and Baxter enter Asset Purchase Agreement for OBI-1

Ipsen and Inspiration Biopharmaceuticals Inc. today announced they entered into an Asset Purchase Agreement (APA) whereby Baxter International (Baxter) agrees to acquire the worldwide rights to OBI-1, a recombinant porcine factor VIII (rpFVIII) in development for congenital hemophilia A with inhibitors and acquired hemophilia A, and Ipsen's industrial facility in Milford (Boston, MA).

24 Jan 2013

Interim results from Inspiration’s OBI-1 and IB1001 hemophilia clinical study

Inspiration Biopharmaceuticals, Inc. (Inspiration) announced interim clinical results for the company's two lead product candidates, an intravenous recombinant porcine FVIII (OBI-1) in the treatment of serious bleeds in acquired hemophilia A (AHA) and an intravenous recombinant FIX (IB1001) for the treatment and prevention of bleeding in children less than 12 years of age with hemophilia B.

13 Dec 2012

Inspiration, Ipsen receive FDA Fast Track designation for OBI-1 to treat AHA

Ipsen and Inspiration Biopharmaceuticals Inc. today announced that Inspiration has received Fast Track designation from the US Food and Drug Administration (FDA) for OBI-1 in acquired hemophilia A.

20 Nov 2012

Positive interim results from Inspiration's OBI-1 Phase 2/3 study for acquired hemophilia A

Inspiration Biopharmaceuticals, Inc. today reported data from its ongoing Phase 2/3 study evaluating the efficacy of OBI-1, an investigational recombinant porcine factor VIII (FVIII), for the treatment of serious bleeds in people with acquired hemophilia A. According to the interim analysis, seven out of seven trial participants receiving OBI-1 experienced control and subsequent resolution of their bleeds.

9 Jul 2012

Inspiration commences enrollment in second OBI-1 Accur8 clinical trial program for congenital hemophilia A

Inspiration Biopharmaceuticals, Inc. today announced the initiation of patient enrollment in the second of two pivotal studies in the Company's OBI-1 Accur8 clinical trial program.

28 Nov 2011

Ipsen, Inspiration partner to launch hemophilia product portfolio in Europe

Ipsen and Inspiration Biopharmaceuticals Inc. today announced they have entered into a strategic partnership agreement, to create a European hemophilia commercial organization, to launch Inspiration's hemophilia product portfolio in Europe.

30 Aug 2011

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. presented data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.

28 Jul 2011

Inspiration presents IB1001 PK data for treatment of hemophilia B

Inspiration Biopharmaceuticals, today presented pharmacokinetic data on its lead product, IB1001, a recombinant factor IX for the treatment and prevention of bleeding in individuals with hemophilia B.

3 Feb 2011

Ipsen initiates patient treatment in phase III OBI-1 study for acquired hemophilia A

Ipsen announced today that its partner Inspiration Biopharmaceuticals, Inc. has initiated treatment of patients in the first of two phase III pivotal clinical studies of OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, for the treatment of acquired hemophilia A, a rare, though potentially life-threatening bleeding disorder.

19 Nov 2010

Inspiration receives two grants under QTDP program to advance development of IB1001, OBI-1 products

Inspiration Biopharmaceuticals, Inc. today announced the Company was awarded two grants, totaling $488,958, under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP).

9 Nov 2010

Ipsen reports consolidated group sales of €1,032.8M for 2009

Ipsen reported today its sales for the fourth quarter and full year 2009.

1 Feb 2010

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today announced the formation of a strategic partnership between Ipsen and Inspiration Biopharmaceuticals ("Inspiration") to create a world leading hemophilia franchise, an important milestone for the Celtic Pharma portfolio.

21 Jan 2010

FDA approves new formulation of genetically engineered version of Factor VIIa plasma protein

The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

9 May 2008