Navigation Links
Inspiration Biopharmaceuticals Announces Filing of Biologics License Application (BLA) for IB1001, a Recombinant Factor IX Product for People with Hemophilia B
Date:4/16/2012

possible."

The IB1001 BLA filing includes a comprehensive set of pharmacokinetics safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B.  A surgery substudy was also included.

John Taylor, Co-Founder and Chairman of Inspiration, stated, "With sons affected by hemophilia B, Inspiration co-founder Scott Martin and I are acutely aware of the impact of limited treatment options on families. We believe more choice can help us achieve our mission to broaden access to care—increasing the supply of products, driving healthy competition, and supporting prophylaxis, which is rapidly becoming the standard of care in hemophilia. We believe that the approval of IB1001 will be the first step in our journey to make broader access to care a reality for thousands of individuals with hemophilia."

About IB1001IB1001 is an intravenous rFIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed pivotal Phase 3 clinical studies that support the filling of the BLA, conducted at study sites in the U.S., Europe and India.

To date, IB1001 has been well tolerated by patients and pharmacokinetic (PK) analyses have demonstrated non-inferiority to the one approved rFIX product currently marketed for the treatment of hemophilia B.  Confirmatory PK studies reported at the 53rd Annual Meeting of the American Society of Hematology showed no evidence of development of inhibitors during treatment periods ranging from 4 to 18 months.

Results recently presented at the 5th Annual Congress of the European Association for Haemophilia and Allied Disorders demonstrated that IB1001 provided effective surgical hemostasis in study participants with hemophilia B undergoing major surgical procedures.

About Inspiration BiopharmaceuticalsInspiration Biopharmaceuticals is exclusively dedicated to developing treatments for hemophilia, with a
'/>"/>

SOURCE Inspiration Biopharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Inspiration Biopharmaceuticals Presents Safety Data on IB1001, a Novel Recombinant Factor IX for the Treatment of Hemophilia at the International Society on Thrombosis and Haemostasis (ISTH) Annual Meeting
2. Using magnetic toys as inspiration, researchers tease out structures of self-assembled clusters
3. Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B
4. Inspiration Biopharmaceuticals Moves Corporate Headquarters to Cambridge, Massachusetts
5. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Second Quarter 2008 Financial Results on Monday, August 11, at 8:30 A.M. EDT
6. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
7. Bayer Broadens Its Manufacturing Basis for Biopharmaceuticals in Tobacco Plants
8. Nomad Bioscience: New Plant Biotechnology Company Founded to Focus on Biomaterials and Biopharmaceuticals
9. Morria Biopharmaceuticals Plc Announces Results From its Pre-Clinical Screening of Novel Anti-Inflammatory Compounds
10. Keryx Biopharmaceuticals Notified that Nasdaq Has Extended Minimum Bid Price Rule Compliance Period
11. Morria Biopharmaceuticals Plc to Present at the Rodman & Renshaw 10th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... 17, 2014 Based on the ... surgical imaging market is dominated by four major ... imaging market. These players include GE Healthcare (U.K.), ... (Germany). , Full Report Copy at ... Healthcare can be attributed to its strong product ...
(Date:12/17/2014)... 2014 Ipsen Biopharmaceuticals, Inc., an ... IPSEY), today announced that Somatuline® Depot® ... was approved by the U.S. Food and Drug ... tumors (GEP-NETs) in adult patients with unresectable, well ... to improve progression-free survival (PFS). , “The approval ...
(Date:12/17/2014)... (PRWEB) December 17, 2014 Xeno ... Excellence following its most recent COLA inspection. Xeno ... COLA, a national healthcare accreditation organization. Accreditation is ... of quality in day-to-day operations, demonstrate continued accuracy ... a rigorous on-site laboratory survey. , ...
(Date:12/17/2014)... -- Vermillion, Inc. (NASDAQ: VRML ), a bio-analytic ... next step in its expanded strategy to rebuild the ... naming of current Chief Operating Officer, Valerie Palmieri ... Chairman of the Board and CEO James LaFrance ... are effective January 1, 2015. "Jim and ...
Breaking Biology Technology:Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 2Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 4Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 2Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 3Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 4Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 5Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 6Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 7Ipsen Announces the FDA Approval of Somatuline® Depot® (lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors 8Xeno Diagnostics Receives 3rd Award for Laboratory Excellence 2Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 2Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 3Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 4
... BOSTON, Sept. 8 PAREXEL International,Corporation (Nasdaq: ... updated its forward-looking financial guidance for the,first quarter ... and for the,full Fiscal Year, in conjunction with ... and other factors discussed herein., Josef von ...
... FREMONT, Calif., Sept. 8 Vermillion, Inc.,(Nasdaq: ... a,team of scientists at Stanford University and Vermillion has ... General Meeting of the,PAD Coalition. Led by Dr. John ... Scientific Officer at Vermillion, Inc., the research team,discovered a ...
... Appointments Strengthen Executive Team, FREMONT, Calif., Sept. ... company developing a novel transdermal,delivery technology, today announced ... and CEO. The company also announced several recent,appointments ... chief,operating officer and president; John M. Vuko, executive ...
Cached Biology Technology:PAREXEL International Updates Financial Guidance in Conjunction With the Acquisition of ClinPhone Plc and Other Factors 2PAREXEL International Updates Financial Guidance in Conjunction With the Acquisition of ClinPhone Plc and Other Factors 3PAREXEL International Updates Financial Guidance in Conjunction With the Acquisition of ClinPhone Plc and Other Factors 4PAREXEL International Updates Financial Guidance in Conjunction With the Acquisition of ClinPhone Plc and Other Factors 5Vermillion and Stanford Scientists Receive 'Best Research Award' From the PAD Coalition 2Vermillion and Stanford Scientists Receive 'Best Research Award' From the PAD Coalition 3Zosano Pharma, Inc. Announces Appointment of Gail Schulze as Chair and CEO 2Zosano Pharma, Inc. Announces Appointment of Gail Schulze as Chair and CEO 3Zosano Pharma, Inc. Announces Appointment of Gail Schulze as Chair and CEO 4
(Date:12/11/2014)... 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/twhjll/biometrics_market ) has announced the addition ... Region 2015-2019"  report to their offering. ... is advances in technology. With continuous advances in ... to the latest standard that meets the needs ...
(Date:12/11/2014)... , Dec. 10, 2014  Data Sciences International ... has released a new series of digital telemetry ... toxicology researchers. M series, part of the PhysioTel™ ... the best possible physiologic data when incorporating functional ... functional endpoints to toxicology studies has evolved from ...
(Date:12/10/2014)... 9, 2014  Wake Forest Baptist Medical Center today announced ... School of Medicine. Funding for this $50 million capital ... will be publicly launched next summer. ... former 60 series R.J. Reynolds Tobacco Company complex, adjacent ... begin immediately with plans to be ready to welcome ...
Breaking Biology News(10 mins):Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2New telemetry implants expected to change how large animal toxicology studies are conducted 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 3Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 4
... Many ancient crustaceans went extinct following a massive collapse of ... suggests modern species living in rapidly declining reef habitats may ... appear in the November issue of Geology , the ... reefs and the number of decapod crustaceans, a group that ...
... exhaust particles from traffic pollution leads to increased asthma ... this is due to increased blood levels of IL-17A, ... children with high diesel exposure. , The study by ... online in the Journal of Allergy and Clinical ...
... of the American Association of Feline Practitioners (AAFP) ... patients based on risk assessment., From ... The American Association of Feline Practitioners, (AAFP) ... updated guidelines on appropriate feline vaccination schedules based ...
Cached Biology News:Fossil record shows crustaceans vulnerable as modern coral reefs decline 2Fossil record shows crustaceans vulnerable as modern coral reefs decline 3Appropriate vaccinations schedules for feline patients outlined 2
Request Info...
... trap mass spectrometer enables high-throughput solutions for ... linear ion trap mass spectrometer is designed ... the fast cycle time and increased sensitivity ... an attractive price. The combination of ...
... SYBR Safe DNA gel stain was developed specifically ... ethidium bromide for staining DNA in agarose or ... less mutagenic than ethidium bromide but SYBR Safe ... ethidium bromide. SYBR Safe stain comes as a ...
... some the things youll be telling others after ... by Erica Golemis, One look at the table ... topics in protein interaction will tell you immediately ... a part of your personal protein chemistry library. ...
Biology Products: