Abstract: The present invention provides a needle unit (10) for use with a pen injection device, wherein the needle unit (10) comprises a needle shield (50) and an axially movable needle hub (25).

Abstract: The present invention provides a needle assembly (1) for a drug delivery device, comprising a needle hub (25) in which a needle (15) is fixedly mounted, the needle (15) extending along a reference axis and comprising a needle body with a lumen and a distal needle end portion adapted for insertion through a skin layer, a needle shield (12) axially displaceable relative to the needle hub (25) between an extended position in which the distal needle end portion is covered and a retracted position in which the distal needle end portion is exposed, the nee-dle shield (12) being biased towards the extended position, and an elastomeric plug member (10) fitted tightly around a portion of the needle (15), the plug member (10) comprising a self-sealing front section (10.

Abstract: The present invention is directed to use of the GLP-1 receptor agonist semaglutide in medical therapy for the treatment of non-alcoholic steatohepatitis.

Abstract: This invention is in the field of protein conjugates. More specifically the invention relates to oligomer extended insulins with covalently attached Fc monomer polypeptides, for use in the treatment of a metabolic disorder or condition, and to methods of producing such oligomer extended insulin-Fc conjugates. The invention also relates to novel Fc fragments, to intermediate products, and to the use of such intermediate products in processes for the synthesis of the oligomer extended insulin-Fc conjugates of the invention. Finally the invention provides pharmaceutical compositions comprising the oligomer extended insulin-Fc conjugates of the invention, and relates to the use of such compositions for the treatment or prevention of medical conditions relating to metabolic disorders or conditions.

Abstract: Systems and methods are provided for adjusting a standing insulin medicament dosage regimen for a subject. Fasting events are identified using autonomous timestamped glucose measurements of the subject in a first data set. A second data set, from one or more insulin pens used to apply the standing regimen, comprises records, each record comprising a timestamped event specifying an amount of injected insulin medicament. Each fasting event is characterized as adherent or nonadherent. A fasting event is adherent when the second data set includes one or more records that temporally and quantitatively establish adherence with the standing regimen during the fasting event. Conversely, a fasting event is nonadherent when the second data set fails to temporally and quantitatively establish adherence with the standing regimen.

Abstract: The invention relates to a method of stabilizing highly concentrated protein solutions during ultrafiltration by addition of sucrose to the highly concentrated protein solution, in particular, but not exclusively to a method of stabilizing highly concentrated antibody solutions during ultrafiltration by addition of sucrose to the highly concentrated antibody solution.

Abstract: A method of manufacturing a pen drug delivery device comprising the steps of (i) providing a drug delivery device comprising a dose indicator member adapted to move relative to a housing during dose setting and dose expelling corresponding to an axis of rotation, the indicator member having an initial position corresponding to no dose amount being set, (ii) arranging the indicator member in the initial rotational position, and (iii) providing on the housing and on the indicator member respectively a pair of zero markers having a predetermined rotational offset. By this arrangement the issue of finding the correct initial (zero) rotational position of the indicator member is addressed by providing corresponding and rotationally paired zero markings on the pen housing and the indicator member after the pen device has been assembled, this allowing the “true” initial position to be detected by image capture and subsequent image analysis.

Abstract: The present invention relates to a recombinant E. coli cell harbouring a recombinant plasmid wherein said E. coli cell has a thermo sensitive regulation of an essential E. coli gene.

Abstract: Systems and methods are provided for adjusting a basal/bolus ratio in a standing insulin regimen for a subject that comprises daily amounts of basal and bolus insulin medicaments that define an initial basal/bolus ratio. A data set comprising glucose measurements of the subject with a respective timestamp for each such measurement over a time course is obtained. One or more fasting events are identified in the time course. A temporal glucose gradient is computed for each fasting event using the glucose measurements in the data set within the fasting event time period. Fasting event glucose gradients are used to determine whether to recommend adjustment to the basal/bolus ratio for the subject without change to the daily total insulin medicament. The recommended adjustment to the basal/bolus ratio is communicated when the determination is made to make the recommended adjustment to the basal/bolus ratio for the subject.

Abstract: A drug delivery device comprises a housing (201) and an expelling assembly with a piston rod (220), a drive tube (260) with an outer surface and a scale drum (270) arranged between the drive tube and the housing, the scale drum being coupled to the housing and the drive tube outer surface. The device further comprises a drive spring (255) arranged between the housing and the drive tube, and setting means (280) allowing a user to simultaneously set a dose amount to be expelled and strain the drive spring correspondingly by rotation of the drive tube. The scale drum is coupled to the drive tube via a spline connection, wherein the drive spring is arranged proximally of the spline connection when the spline connection is in its proximal-most position.

Abstract: The present invention relates to an injection device comprising a torsion spring operatively connected to a dose setting member being adapted to set a dose to be ejected from the injection device. A rotatably mounted display member adapted to display the dose to be ejected in accordance with a setting of the dose setting member is also provided. The rotatably mounted display member is adapted to be rotated over an angle corresponding to at least one revolution of the display member. The display member may be implemented as a dose indicator barrel having numerals arranged along a helical path on an outer surface thereof, or alternatively, as a counting device having two or more display wheels having numerals arranged on an outer surface thereof.

Abstract: An assembly includes a sealed drug reservoir unit, a subcutaneous flow conducting device in the form of a needle unit or an infusion set, and a flow communication unit. The flow communication unit includes a proximal hollow needle adapted to penetrate a needle-penetrable septum of the reservoir, a first flow-way inflow communication with the proximal needle and comprising a pressure-controlled valve, a second flow-way in flow communication with the first flow-way, an amount of preservative arranged to react with a substance received by the second flow-way, and distal flow communication structure adapted to provide flow communication between the second flow-way and the needle unit. The valve is controlled to open when the reservoir is pressurized, the preservative being provided to react with substances introduced to the second flow way via the needle unit.

Abstract: The present invention provides a drug injection device (1) for delivering multiple doses of drug, comprising: a housing (2) extending along a main axis, a dose expelling mechanism comprising a piston rod (60) configured to move relative to the housing (2) from a first position to a second position to cause ejection of a dose of drug, the piston rod (60) extending between a proximal piston rod end and a distal piston rod end and comprising a dosing track (63), the piston rod (60) further being movable relative to the housing (2) from an initial pre-use position to a final end stop position to cause accumulated ejection of a predefined total dose, a dosing track follower (17) fixed with respect to the housing (2) and adapted to travel the dosing track (63) during dose ejection, a dose setting mechanism operable to set the dose to be ejected by the dose expelling mechanism, electronic means (82, 90, 91, 92, 95) for registering a dose setting operation and for registering a dose size of an ejected dose, and a dis

Abstract: The invention provides a pen-type injection device (1) with a piston rod brake mechanism for improving the determination of an expelled dose.

Abstract: Drug delivery system comprising expelling means for expelling an amount of drug from a reservoir, the expelling means comprising dose setting means (11, 21, 122) allowing a user to set a dose to be expelled, and actuation means (123) for releasing the drug expelling means to expel the set dose. The dose setting means comprises a drive sleeve (22) adapted to be rotated to set a dose, and a rotatable driven member (21) arranged for being rotationally driven by the drive sleeve (22) in a slaved rotational movement by means of a torque transfer coupling between the drive sleeve (22) and the rotatable driven member (21). The system further comprises an electronically controlled capturing system for capturing data representing a property related to the amount of drug expelled from the reservoir by the expelling means, and switch means configured to initiate an action within the electronically con-trolled capturing system upon occurrence of the slaved rotational movement.

Abstract: The present invention provides a drug delivery system (1) comprising a drug delivery device (2, 3) carrying at least one reservoir (40a, 40b), and a needle unit (4) being attachable to the drug delivery device (2, 3) in axial extension thereof and adapted to establish a flow way between the at least one reservoir (40a, 40b) and a drug delivery site. The needle unit (4) comprises a needle structure (11) comprising a front needle portion (12) for entering the drug delivery site, and at least one back needle portion (13a, 13b) for insertion into the at least one reservoir (40a, 40b), and a needle shield (20).

Abstract: The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.

Abstract: The disclosure provides methods of treating inflammation without inducing immune suppression. The method comprises administering a therapeutically effective amount of an IL-6 antagonist at a dose sufficient to reduce inflammation without causing immune suppression.

Abstract: The invention relates to an injection device comprising an End-of-Content mechanism. The End-of-Content mechanism comprises a piston rod (10) being driven forward by a rotatable piston rod guide (20), a driver (50) attached to a dose setting tube (30) and an End-of-Content tube (40). The End-of-Content tube is moved axially forward during dose setting a distance which correlates to the size of the dose being set. When the accumulated set and ejected dose equals the injectable amount initially available in the cartridge (3), the End-of-Content tube engages a lock mechanism provided in the piston rod guide and the driver engages a stop surface on the End-of-Content tube. Once the End-of-Content mechanism is locked, no further dose can be set and the piston rod guide cannot be rotated. In order to provide a proper engagement between the piston rod guide and the driver, the End-of-Content mechanism is released during dose expelling.

Abstract: The present invention provides a drug delivery device (2, 3; 102) for sequential administration of substances, comprising a first variable volume reservoir (40a; 140a) holding a first substance and comprising a first outlet (41 a, 141 a) and a first displaceable wall (43a; 143a), a second variable volume reservoir (40b; 140b) holding a second substance and comprising a second outlet (41 b; 141 b) and a second displaceable wall (43b; 143b), a first wall actuation structure (65a, 70a, 75a, 77a; 177a) activatable to move the first displaceable wall (43a; 143a) and thereby expel a dose of the first substance through the first outlet (41 a; 141 a), a second wall actuation structure (65b, 70b, 75b, 77b; 177b) activatable to move the second displaceable wall (43b; 143b) and thereby expel a dose of the second substance through the second outlet (41 b; 141 b), and a drive structure (90; 190) for activating the first wall actuation structure (65a, 70a, 75a, 77a; 177a) and the second wall actuation structure (65b, 70b,