Abstract: Methods, systems and kits for the identification, assessment and/or treatment of a subject having multiple sclerosis are disclosed.

Abstract: Provided are recombinant Factor VIII proteins, e.g., human Factor VIII proteins with heterologous moieties inserted into flexible permissive loops located in the Factor VIII A domains, while retaining the procoagulant activity of Factor VIII.

Abstract: The present invention provides methods of administering a clotting factor by a fixed dosing regimen; methods of reducing, ameliorating, or preventing one or more symptoms of a bleeding disease or disorder; and a kit comprising a dotting factor useful for a fixed dosing regimen. While plasma-derived and recombinant clotting factor products allow hemophilia patients to live longer and healthier, hemophilia still remains one of the most costly and complex conditions to manage.

Abstract: Disclosed are immunogenic Nogo receptor-1 polypeptides, Nogo receptor-1 antibodies, antigen-binding fragments thereof, soluble Nogo receptors and fusion proteins thereof and nucleic acids encoding the same. Also disclosed are Nogo receptor antagonist polynucleotides. Also disclosed are compositions comprising, and methods for making and using, such Nogo receptor antibodies, antigen-binding fragments thereof, soluble Nogo receptors and fusion proteins thereof, nucleic acids encoding the same and antagonist polynucleotides.

Abstract: The present invention pertains to methods of increasing the efficiency of producing a bioproduct. In some embodiments, the method increases the quantity of a bioproduct produced, or decreases bioproduct production time, in a bioreactor cell culture producing the bioproduct, the method comprising, (a) intermittently or continuously analyzing the concentration of one or more nutrients in the bioreactor cell culture; and (b) adding to the bioreactor cell culture additional nutrient media when the concentration of the one or more nutrients is lower than a target value.

Abstract: The invention provides chimeric clotting factors comprising an activatable clotting factor and an enhancer moiety. The activatable clotting factor allows the chimeric clotting factor to be activated at the site of coagulation. The enhancer moiety can additionally improve procoagulation activities of the chimeric clotting factors. The chimeric clotting factors can further be improved by fusion to a half-life extender, which improves a pharmacokinetics property of the chimeric clotting factor. The invention also includes methods of making and methods of using these chimeric clotting factors.

Abstract: Aspects of the invention provide therapeutic recombinant protein preparations and methods of preparing therapeutic recombinant protein, which methods include contacting recombinant protein preparations with zwitterionic detergent at or above critical micelle concentration of the detergent.

Abstract: The present invention provides methods of reducing or decreasing the annualized bleeding rate of a human subject having hemophilia by administering a long acting Factor VIII polypeptide. The long-acting FVIII polypeptide can be used for individual prophylaxis, weekly prophylaxis, episodic (on-demand) treatment, or perioperative management of hemophilia. The present invention relates generally to the field of therapeutics for hemostatic disorders.

Abstract: The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Abstract: The invention relates to novel polyalkylene glycol compounds and methods of using them. In particular, compounds comprising a novel polyethylene glycol conjugate are used alone, or in combination with antiviral agents to treat a viral infection, such as chronic hepatitis C.

Abstract: Compounds of formula (I) can modulate the activity of autotaxin (ATX).

Abstract: A method of treating a mammal for a condition associated with undesired cell proliferation comprising administering to said mammal an effective amount of a TACI reagent, wherein said reagent extends mean survival time of said mammal by about 10% or more as compared to the absence of administering the TACI reagent.

Abstract: Methods and compositions for determining whether a subject is at risk for PML, including subjects being treated with immunosuppressants, by determining whether the subject harbors a JCV variant with reduced binding for sialic acid relative to a normal JCV, are presented. Furthermore, combinations of JCV-VP1 sequence variations that are associated with PML and that can be used as a basis of an assay for identifying subjects susceptible to PML, subjects with PML (e.g., early stage PML), or subjects at risk of developing PML in response to an immunosuppressive treatment are provided.

Abstract: Methods, systems and kits to detect and/or quantify disease progression in a subject having a progressive form of MS are disclosed.

Abstract: The present invention provides a new method for isolating and enriching human regulatory T cells. The enriched cells are useful in the treatment of autoimmune disease.

Abstract: Compounds of formula (I) can modulate the activity of one or more SIP receptors and/or the activity of autotaxin (ATX).

Abstract: The present invention provides cell lines for producing single chain FVIII polypeptides, e.g., chimeric single chain FVIII polypeptides, methods of producing single chain FVIII polypeptides, single chain FVIII polypeptides, and methods of treating Hemophilia A with a single chain Factor VIII polypeptide.

Abstract: The present disclosure provides methods and compositions for diagnosing and treating subject having a bleeding disorder. The disclosed methods comprise contacting a sample, e.g., a blood or plasma sample obtained from the patient, with an activation mixture comprising an activated coagulation factor and a phospholipid mixture, wherein the activation mixture is dried onto a solid substrate. Also provided is a global hemostasis test based on the integration of clotting time (Ct) and pharmacokinetics data. The methods and compositions presented can be applied to point-of-care diagnostic systems.

Abstract: The present disclosure provides protease-activatable procoagulant compounds comprising a procoagulant polypeptide, e.g., a procoagulant peptide and/or clotting factor, and a linker comprising a protease-cleavable substrate (e.g., a synthetic thrombin substrate) and a self-immolative spacer (e.g., p-amino benzyl carbamate). Upon cleavage of the protease-cleavable substrate by a protease (e.g., thrombin), the self-immolative spacer cleaves itself from the procoagulant polypeptide such that the polypeptide is in an underivatized and active form. Also provided are pharmaceutical compositions, methods for treating bleeding disorders using the disclosed compounds, methods of enhancing in vivo efficacy of procoagulant polypeptides, methods of increasing the efficacy of proteolytic cleavage of compounds comprising procoagulant polypeptides, methods of activating procoagulant polypeptides, and methods of releasing a procoagulant polypeptide from a heterologous moiety such as PEG.

Abstract: Methods for extended treatment of multiple sclerosis are described.