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Novo Nordisk files for regulatory approval of turoctocog alfa for haemophilia A in the US and EU

Novo Nordisk today announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A. “We are very excited about having […]

Biogen's Hemophilia Drug Meets Late-stage Trial Goal

(Reuters) – Biogen Idec Inc said on Wednesday its experimental treatment for patients with hemophilia B, a rare inherited blood disorder that impairs coagulation, met the main goal of controlling bleeding in a late-stage trial. A single injection of the long-lasting clotting factor, being developed in partnership with Swedish Orphan Biovitrum, controlled bleeding in 90.4 […]

Novo Nordisk discontinues development of vatreptacog alfa following analysis of phase 3 results

Novo Nordisk today announced the decision to discontinue the development of vatreptacog alfa, a fast-acting recombinant factor VIIa analogue for haemophilia patients with inhibitors. The decision follows analysis of the data from the phase 3a trial adeptTM 2. On 9 August, Novo Nordisk announced that a few patients in the trial had developed anti-drug antibodies […]

Intern trio distinguish themselves in the Bayer Hemophilia Leadership Development Program

We’re proud to announce that our three summer interns have recently completed the Bayer Hemophilia Leadership Development Program (BHLDP). All three distinguished themselves as future leaders in the bleeding disorders community through their hard work, enthusiasm and can-do spirit. The interns spent time both at Bayer and at local hemophilia advocacy organizations to round out […]

Patient Services, Inc. and Baxter Introduce the Hemophilia Co-Pay/Co-Insurance Assistance Pilot Program

Midlothian, VA — Many members of the hemophilia community are struggling with the high costs of healthcare. At Patient Services, Inc. (PSI), we recognize the importance of assisting patients to afford and access treatment. Therefore, PSI is pleased to announce that Baxter Healthcare Corporation has developed a 12-month Hemophilia Co-pay/Co-insurance Assistance Pilot Program which will […]

Baxter Announces FDA Approval of Advate 4,000 IU Dosage Strength

DEERFIELD, Ill., JULY 16, 2012 – Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method].  ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes […]

BioRx Receives Limited Distribution Rights to Corifact® for the Treatment of Congenital Factor XIII Deficiency

Cincinnati, OHIO - July 11, 2012 - BioRx, a national specialty pharmacy and infusion services provider, has been added to the limited distribution network for Corifact® [Factor XIII Concentrate (Human)], manufactured by CSL Behring. Corifact is the only FDA-approved treatment for congenital Factor XIII (FXIII) deficiency, reported to be one of the rarest bleeding disorders in the […]

Inspiration Biopharmaceuticals Announces Clinical Hold of Clinical Trials Evaluating IB1001 for the Treatment and Prevention of Bleeding in Hemophilia B

Inspiration releases an important update about their clinical trial program for IB1001, an intravenous recombinant factor IX (rFIX) product that is being investigated for the treatment and prevention of bleeding episodes in people with hemophilia B. Click here for the official IBI press release.

Biogen Idec and Sobi Initiate Global Clinical Trials of Long-Lasting Hemophilia A and B Product Candidates in Children

Weston, Mass and Stockholm, Sweden – July 5, 2012 – Biogen Idec (NASDAQ:BIIB) and Swedish Orphan Biovitrum (STO:SOBI) today announced the initiation of two global pediatric clinical trials of the companies’ long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc) in hemophilia A and B. rFVIIIFc and rFIXFc are fully-recombinant clotting […]

Community Pharmacists Lose Bid to Immediately Block Express Scripts-Medco Deal

By Rebecca Adams, CQ HealthBeat Associate Editor A federal judge has denied the request of a group of community pharmacists to immediately stop the acquisition of Medco Health Solutions by Express Scripts, Inc. The judge will next decide whether to throw out the lawsuit. The pharmaceutical benefits management companies Express Scripts and Medco merged on […]

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