Abstract: Systems and methods are provided for optimizing basal administration timing in a standing basal insulin regimen of a subject. The regimen specifies a total amount of basal insulin medicament, one or more basal injection event types for a recurring period, and an apportionment of the total amount of medicament between the injection event types. Time stamped glucose measurements of the subject are obtained over a past time course comprising a plurality of instances of the recurring period. When the glucose measurements satisfy a stop condition, a recommended adjustment is determined that comprises a change in the number of injection event types in the regimen and/or a change in the apportionment of insulin medicament between injection event types. The recommended adjustment is communicated to the subject for manual adjustment of the regimen, an insulin pen charged with delivering the regimen to the subject, or a health care practitioner associated with the subject.

Abstract: The application discloses bispecific TFPI antibodies that are capable of specifically and simultaneously binding two epitopes within TFPI (1-161). Such bispecific antibodies strongly enhance thrombin generation by neutralising TFPI, even where the concentration of TFPI is elevated. Bispecific antibodies of the invention or compositions comprising them may be used for the treatment of subjects with a coagulopathy.

Abstract: Systems and methods for treating a subject are provided. A first dataset comprising timestamped autonomous glucose measurements of the subject over a first time course is obtained. A second dataset, associated with a standing insulin regimen for the subject over the first time course and comprising insulin medicament records, is also obtained. Each record comprises a timestamped injection event including an amount and type of insulin medicament injected into the subject by an insulin pen. The first and second datasets serve to calculate a glycaemic risk measure and an insulin sensitivity factor of the subject during the first time course, which are used to obtain a basal titration schedule and a fasting blood glucose profile model over a subsequent second time course for the subject. The model predicts the fasting blood glucose level of the subject based upon amounts of basal insulin medicament injected into the subject.

Abstract: The present invention relates to plasmids useful for prevention and/or delay of e.g. type 1 diabetes.

Abstract: The present invention relates to insulin degludec for use in medicine.

Abstract: The present invention concerns a prefilled injection device having a container and a dose setting mechanism encapsulated inside a housing. The injection device incorporates an axial variable connection such that a distance between a distal end of a piston rod and a plunger is minimized preferably to zero.

Abstract: The present invention relates to generation of functional beta cells from human pluripotent stem cell-derived endocrine progenitors. The present invention also relates to functional beta cells produced by said methods and uses of said beta cells.

Abstract: The invention relates to a derivative of a GLP-1 peptide, which peptide comprises a first K residue and a second K residue, at positions corresponding to position 26, and 34, respectively, of GLP-1(7-37) (SEQ ID NO:1), and a maximum of eight amino acid changes as compared to GLP-1(7-37); which derivative comprises two protracting moieties attached to said first and second K residue, respectively, via a linker, wherein the protracting moiety is Chem. 2: HOOC—C6H4—O—(CH2)y—CO—*, in which y is an integer in the range of 6-13; and the linker comprises Chem. 3a: *—NH—(CH2)q—CH[(CH2)w—NR1R2]—CO—*, wherein q is an integer in the range of 0-5, R1 and R2 independently represent *—H or *—CH3, and w is an integer in the range of 0-5; or a pharmaceutically acceptable salt, amide, or ester thereof. The invention also relates to the pharmaceutical use thereof, for example in the treatment and/or prevention of all forms of diabetes and related diseases, as well as to corresponding novel peptide and linker intermediates.

Abstract: An autoinjector (100?) for expelling a single dose of a drug from a held cartridge (600) comprising a piston (630). The autoinjector includes a needle shield (350, 380?) axially movable from an initial extended position via a triggering position to a trigger release position. The needle shield (350, 380?) is operatively coupled to a plunger release element (320?, 1320) cooperating with a plunger (310, 400) to define a releasable retaining mechanism that retains the plunger release element (320?, 1320) threadedly engaged with a base thread component (204?, 1204) in a predefined relative rotational and axial position and against rotational bias provided by an actuator (330). The needle shield (350, 380?) is configured for operating the retaining mechanism to release the retaining of the plunger release element (320?, 1320) and the base thread component (204?, 1204) from the predefined relative rotational and axial position upon the needle shield (350, 380?) being moved into the trigger release position.

Abstract: The invention relates to MIC-1 compounds for use in the prevention and/or treatment of obesity, wherein the MIC-1 compounds is administered simultaneously, separately or sequentially with a GLP-1 compound.

Abstract: The present disclosure relates to a method of treating non-alcoholic steatohepatitis (NASH) comprising administering to a subject with NASH a combination therapy comprising semaglutide, firsocostat, and/or cilofexor.

Abstract: A drug delivery device for administration to a subject is provided. In some embodiments, the drug delivery device includes a reservoir containing an active pharmaceutical ingredient and a potential energy source. The drug delivery device also includes a trigger operatively associated with the potential energy source, where the trigger is configured to actuate at a predetermined location within the subject. The drug delivery device also includes a rupturable membrane disposed along a flow path extending between the reservoir and an outlet, where the membrane is configured to rupture when the trigger is actuated. Once the trigger is actuated, the potential energy from the potential energy source may be released to expel the active pharmaceutical ingredient in a jet through the outlet.

Abstract: The invention relates to a medical injection device having polymeric housing. The housing comprises a moulded outer housing element and a moulded ring-shaped unitary element. The ring-shaped unitary element carries a pointer and a thread segment in predetermined and correlated positions. The pointer points to indicia on a scale drum and the thread segments guides the scale drum. The outer housing element is moulded over the unitary element to form one single component.

Abstract: A drug delivery assembly comprising a sensor system in combination with an indicator arranged to rotate, the amount of rotation being indicative of the size of an expelled dose amount. The sensor system comprises a sensor assembly adapted to measure a rotational position and/or a rotational movement of the indicator, the sensor assembly comprising a sensor element adapted to be operated at a non-constant sampling frequency. A processor is configured to determine on the basis of measured values from the sensor element rotational position(s) and/or amount of rotational movement of the indicator, as well as rotational speed of the indicator. To optimize energy consumption the processor is configured to dynamically control the sampling frequency in response to the determined rotational speed.

Abstract: The present invention relates to multispecific procoagulant antibodies capable of binding to coagulation Factor IX (FIX) and/or the activated form thereof Factor IXa (FIXa), and Factor X (FX) and/or the activated form thereof Factor Xa (FXa) and promoting FX activation by FIXa, antibodies binding their epitopes or parts thereof and methods and composition for treating subjects suffering from a coagulopathy such as haemophilia A as well as kits, methods of manufacture and methods of use.

Abstract: The present invention relates to specific antibodies and use thereof, such as for identifying and/or quantifying liraglutide fibrils and/or semaglutide fibrils.

Abstract: The present invention relates to novel insulins or insulins analogues that are extended with predominantly sequences of polar amino acid residues in order to improve the half-life and stability of the drug substance. The invention also provides pharmaceutical compositions comprising such drug substances, and relates to the use of such drug substances for the treatment or prevention of medical conditions relating to diabetes.

Abstract: The present disclosure provides methods of treating diuretic resistance by administering an IL-6 antagonist to patients who require diuresis. In typical embodiments, the patient has heart failure. Optionally, the patient has elevated urine levels of IL-6, plasma levels of IL-6, or both urine and plasma levels of IL-6.

Abstract: A drug delivery device comprising a rotatable scale drum, a trigger member, an actuation member, a trigger spring acting on the trigger member and being energized by movement of the actuation member, as well as an end-of-dose switch adapted to be actuated by movement of the trigger member. The trigger member is adapted to be arranged in an axially supported position against the action of the energized trigger spring, and released from the axially supported position when the scale drum is rotated from a set position to an end-of-dose position, whereby the trigger member is moved axially by the trigger spring, the end-of-dose switch thereby being actuated.

Abstract: Systems and methods for treating a subject are provided. A first dataset comprising timestamped autonomous glucose measurements of the subject over a first time course is obtained. A second dataset, associated with a standing insulin regimen for the subject over the first time course and comprising insulin medicament records, is also obtained. Each record comprises a timestamped administration event including an amount and type of insulin medicament administered into the subject by an insulin delivery device. The first and second datasets serve to calculate a glycemic risk measure and an insulin sensitivity factor of the subject during the first time course, which are used to obtain a basal rate titration schedule and a fasting blood glucose profile model over a subsequent second time course for the subject. The model predicts the fasting blood glucose level of the subject based upon amounts of insulin medicament administered into the subject.