Abstract: A pre-filled syringe is disclosed, comprising a barrel and a plunger, the barrel having an outlet, the barrel containing a pharmaceutically acceptable solution having a non-physiological pH, wherein the syringe further comprises an ion exchange material. The ion exchange material is provided at a position to allow contact with the pharmaceutically acceptable solution upon ejection of the pharmaceutically acceptable solution from the barrel via the outlet. The ion exchange material is capable of adjusting the pH of the solution from a non-physiological pH, at which the pharmaceutically acceptable solution is stored in order to ensure acceptable shelf life, to a more physiological pH at which the discomfort and/or pain experienced during injection may be alleviated.

Abstract: A method treats a SARS-CoV-2 infection with anakinra. In particular the method treats or alleviates symptoms of respiratory distress and/or hyperinflammation in a patient. The treatment includes administering to a patient in need thereof a daily dose of at least about 400 mg of anakinra.

Abstract: The human Interleukin 1 Receptor antagonist anakinra can be used in the treatment of pancreatic ductal adenocarcinoma (PDAC). The treatment involves administration of a daily dose of approximately at least 200 mg of anakinra to a patient in need thereof, for example to a patient who is undergoing a chemotherapy treatment regimen. The anakinra can be used in related treatment methods and corresponding pharmaceutical compositions.

Abstract: A fusion protein is provided, comprising i) a biologically active polypeptide; and ii) a half-life extending polypeptide moiety comprising 2-80 units independently selected the amino acid sequences according to SEQ ID NO: 1: X1-X2-X3-X4-X5-X6-D-X8-X9-X10-X11 (SEQ ID NO: 1) in which, independently: X1 is P or absent; X2 is V or absent; X3 is P or T; X4 is P or T; X5 is T or V; X6 is D, G or T; X8 is A, Q or S; X9 is E, G or K; X10 is A, E P or T; and X11 is A, P or T. The half-life extending polypeptide moiety has a generally unfolded conformation and provides a fusion protein with a large hydrodynamic radius that may avoid renal clearance. As a result, the biological half-life of the fusion protein is increased and the biological effect of the biologically active polypeptide may thus be prolonged.

Abstract: The present invention relates to compositions comprising anakinra, buffer, and optionally at least one osmolyte and optionally further excipients. Further, the present invention relates to use of said compositions for treatment of for example ophthalmic disorders.

Abstract: The present invention relates to a syringe having a barrel, a plunger arranged to travel within said barrel and a plunger rod for driving the plunger in a bidirectional manner. The plunger rod is provided with a head at a distal end thereof and a plurality of protruding finger grip enhancing means axially spaced along a length of the plunger rod.

Abstract: Methods of reducing aggregation of an aggregating IL-1ra comprising incubating IL-1ra with at least one accessory molecule are provided. Kits comprising IL-1ra and at least one accessory molecule are also provided. Pharmaceutical compositions comprising IL-1ra and at least one accessory molecule are also provided.

Abstract: Methods of reducing aggregation of an aggregating IL-1ra comprising incubating IL-1ra with at least one accessory molecule are provided. Kits comprising IL-1ra and at least one accessory molecule are also provided. Pharmaceutical compositions comprising IL-1ra and at least one accessory molecule are also provided.

Abstract: The present invention relates to C5 binding polypeptides, comprising a C5 binding motif, BM, which motif consists of an amino acid sequence selected from i) EX2X3X4A X6 X7EID X11LPNL X16X17X18QW X21AFIX25X26LX28D, and ii) an amino acid sequence which has at least 86% identity to the sequence defined in i), wherein the polypeptide binds to C5. The present invention moreover relates to C5 binding polypeptides for use in therapy, such as for use in treatment of a C5 related condition, and to methods of treatment.

Abstract: The present invention relates to pharmaceutical compositions comprising anakinra as an active compound in the absence of sodium citrate. The said pharmaceutical compositions are useful for the treatment of IL-1 mediated disorders and for decreasing nociceptive pain during such treatment.

Abstract: Disclosed herein are a modified sulfamidase, a composition comprising a modified sulfamidase, as well as methods for preparing a modified sulfamidase and therapeutic use of such a sulfamidase. In particular, the present disclosure relates to a modified sulfamidase comprising substantially no epitopes for glycan recognition receptors, thereby enabling transportation of said sulfamidase across the blood brain barrier of a mammal, wherein said sulfamidase has catalytic activity in the brain of said mammal.

Abstract: The invention relates to a polypeptide capable of binding human complement component 5 (C5), said polypeptide comprising the amino acid sequence (SEQ ID NO: 296) [BM]-[L2]-QSX42X43LLX46EAKKLX52X53X54Q wherein [BM] is a C5 binding motif; [L2] is an interconnecting loop; X42 is selected from A and S; X43 is selected from N and E; X46 is selected from A, S and C; X52 is selected from E, N and S; X53 is selected from D, E and S, provided that X53 is not D when X52 is N; and X54 is selected from A and S.

Abstract: Disclosed herein are a modified sulfamidase, a composition comprising a modified sulfamidase, as well as methods for preparing a modified sulfamidase and therapeutic use of such a sulfamidase. In particular, the present disclosure relates to a modified sulfamidase comprising substantially no epitopes for glycan recognition receptors, thereby enabling transportation of said sulfamidase across the blood brain barrier of a mammal, wherein said sulfamidase has catalytic activity in the brain of said mammal.

Abstract: The present invention relates to C5 binding polypeptides, comprising a C5 binding motif, BM, which motif consists of an amino acid sequence selected from i) EX2X3X4A X6 X7EID X11LPNL X16X17X18QW X21AFIX25X26LX28D, and ii) an amino acid sequence which has at least 86% identity to the sequence defined in i), wherein the polypeptide binds to C5. The present invention moreover relates to C5 binding polypeptides for use in therapy, such as for use in treatment of a C5 related condition, and to methods of treatment.

Abstract: The present invention relates to C5 binding polypeptides, comprising a C5 binding motif, BM, which motif consists of an amino acid sequence selected from i) EX2X3X4A X6X7EID X11LPNL X16X17X18QW X21AFIX25X26LX28D, and ii) an amino acid sequence which has at least 86% identity to the sequence defined in i), wherein the polypeptide binds to C5. The present invention moreover relates to C5 binding polypeptides for use in therapy, such as for use in treatment of a C5 related condition, and to methods of treatments.

Abstract: Disclosed herein are a modified sulfamidase, a composition comprising a modified sulfamidase, as well as methods for preparing a modified sulfamidase and therapeutic use of such a sulfamidase. In particular, the present disclosure relates to a modified sulfamidase comprising substantially no epitopes for glycan recognition receptors, thereby enabling transportation of said sulfamidase across the blood brain barrier of a mammal, wherein said sulfamidase has catalytic activity in the brain of said mammal.

Abstract: The present invention relates to pharmaceutical compositions comprising anakinra as an active compound in the absence of sodium citrate. The said pharmaceutical compositions are useful for the treatment of IL-1 mediated disorders and for decreasing nociceptive pain during such treatment.

Abstract: The present invention relates to pharmaceutical compositions comprising anakinra as an active compound in the absence of sodium citrate. The said pharmaceutical compositions are useful for the treatment of IL-1 mediated disorders and for decreasing nociceptive pain during such treatment.

Abstract: The present invention relates to improved formulations of recombinant human bile salt stimulated lipase (rhBSSL), including those suitable for forming a lyophilized formulation of rhBSSL, lyophilized formulations of rhBSSL per-se, unit dose forms of rhBSSL and reconstituted formulations of rhBSSL. The formulations of the present invention comprises rhBSSL, a crystalline bulking agent and an amorphous stabilizer that is a different chemical entity to said crystalline bulking agent. The formulations of the present invention have one or more desired properties, including those that relate to stability, decreased aggregation and/or formation of insoluble aggregates in solution. The lyophilized formulations of the present invention have pharmaceutical utility, particularly for the administration of rhBSSL to human infants.

Abstract: The present invention relates to a method to increase the absorption by a human infant of at least one unsaturated fatty acid, said method comprising the enteral administration to said infant of recombinant human bile-salt-stimulated lipase (rhBSSL). In another aspect the invention also relates to a method to improve the visual and/or cognitive development of a human infant, said method comprising the enteral administration to said infant of rhBSSL. Such methods have particular utility for preterm human infants, particular those in medical need of increasing their absorption of or availability to such unsaturated fatty acids. In further aspects, the invention relates to kits, packaged-pharmaceutical-products, recombinant human bile-salt-stimulated lipase and pharmaceutical compositions, in each case useful for increasing the absorption by a human infant of at least one unsaturated fatty acid, or for increasing the visual and/or cognitive development of a human infant.