Abstract: An add-on device adapted to be releasably mounted on a drug delivery device, the add-on device comprising an outer assembly with an add-on dose setting member adapted to be coupled to the outer housing of a pen housing, as well as an inner assembly engaging the pen dose setting member and being in rotational engagement with the add-on dose setting member during dose setting. The invention addresses the issue of preventing transfer of movement from the add-on dose setting member to the inner assembly during dose expelling, which in accordance with the invention is realized by rotationally de-coupling the inner and outer assembly during dose expelling.

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject).

Abstract: Oligonucleotides are provided herein that inhibit NR1H3 expression. Also provided are compositions including the same and uses thereof, particularly uses relating to treating diseases, disorders and/or conditions associated with NR1H3 expression.

Abstract: The invention relates to a derivative of a GLP-1 analogue of a general Formula I, which derivative comprises a side chain attached to a Lys residue at position 34, 35, 36, 37, or 38 of the GLP-1 analogue, which side chain comprises a Branched linker, a 1st and a 2nd Protractor selected from C18 diacid, C20 diacid, and sulfonic acid C16, and at least one Linker element-1 incorporating ethylene glycol units. Linker element-1 may be incorporated in an optional Pre-linker, and/or in a 1st or 2nd Post-linker. The invention also relates to novel GLP-1 analogues, novel side chain intermediate products and their manufacture and use to prepare derivatives of biologically active peptides and proteins, as well as pharmaceutical compositions and medical uses of the analogues and derivatives. The derivatives have very long half-lives while maintaining a satisfactory potency, which makes them potentially suitable for once-monthly administration.

Abstract: Systems and methods for evaluating insulin medicament dosage regimen adherence by a subject are provided. A description of metabolic events the subject engaged in is obtained. Each event comprises a timestamp and a classification that is one of insulin regimen adherent and insulin regimen nonadherent. Events are binned into consecutive time windows on the basis of time to obtain a plurality of subsets. Adherence values are computed. Each adherence value is for a subset and is computed by dividing the insulin regimen adherent events by the total number of events in the subset. Adherence values are combined into a composite value by a process that comprises downweighting a first adherence value, representing a first time window, with respect to a second adherence value, representing a second time window, when the first time window occurs in time before the second time window. The composite value is communicated as a single representation.

Abstract: Methods of manufacturing tissue interfacing components, such as solid needles comprising one or more therapeutic agents, are disclosed. In some embodiments, a method for manufacturing a tissue interfacing component comprises compressing a granular therapeutic agent within a mold cavity of a mold to form a solid tissue interfacing component. The mold cavity may define an elongated shape extending along a longitudinal axis from an opening of the mold cavity to a distal end of the mold cavity, and the granular therapeutic agent may be compressed by moving a mold punch along the longitudinal axis towards the distal end. After compressing the granular therapeutic agent to form the solid tissue interfacing component, the tissue interfacing component may be removed from the mold and subsequently inserted into tissue to deliver the therapeutic agent to a subject.

Abstract: A dosage sensing module for or in a pen drug delivery device and comprising a power source unit, a processor unit and a dosage sensor unit with a first sensor part adapted to be fixed to a part not rotating during dose expelling and comprising a flexible printed circuit board sheet on which a pattern of individual electrical conductive sensor areas are arranged. The sensor unit further comprises a second sensor part adapted to be fixed to the piston rod to follow the rotation thereof during dose expelling. The second sensor part comprises individual structures that together with the conductive sensor areas are adapted to, upon relative rotational movement between the first and second sensor part, provide electrical signals to a processor unit indicative of the relative rotational position between the first and second sensor part.

Abstract: A subject is prescribed short and long acting insulin medicament regimens. When a qualified fasting event occurs, the basal insulin sensitivity estimate of the subject is updated using (i) an expected fasting blood glucose level based upon the long acting insulin medicament dosing specified by the long acting regimen during the fasting event, (ii) glucose measurements contemporaneous with the fasting event and (iii) a prior insulin sensitivity factor. A basal insulin sensitivity factor curve is calculated from the updated basal insulin sensitivity estimate. A bolus insulin sensitivity estimate of the subject is updated upon occurrence of a correction bolus with a short acting insulin medicament using (i) an expected blood glucose level based upon the correction bolus, (ii) glucose measurements after occurrence of the correction bolus, and (iii) a prior insulin sensitivity factor. A bolus insulin sensitivity factor curve is calculated from the updated bolus insulin sensitivity estimate.

Abstract: The invention relates to a derivative of a GLP-1 analogue, which analogue comprises a first K residue and a second K residue, at positions corresponding to position 26, and 37, 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 selected from Chem. 1: HOOC—(CH2)x—CO—*, and Chem. 2: HOOC—C6H4—O—(CH2)y—CO—*, in which x is an integer in the range of 8-16, and y is an integer in the range of 6-13; and the linker comprises Chem. 3: *—NH—(CH2)q—CH[(CH2)w—NR1R2]—CO—*, which is connected at its CO—* end to the epsilon amino group of the first or the second K residue of the GLP-1 analogue, and 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.

Abstract: A shield activated drug delivery device for delivering a plurality of fixed doses comprising a housing, a drive mechanism comprising a drive element (180, 280) adapted to rotate and thereby rotate and axially advance a piston rod (109, 209), wherein the drive mechanism is adapted to expel a dose of the plurality of fixed doses, in response to activation. The injection device further comprises an activation mechanism, and a locking-and-resetting mechanism for releasably locking the shield in an activation position, in response to rotating the shield, and for inducing a rotational movement of the shield, in response to the drive element releasing a releasable lock.

Abstract: The present invention provides a sensor module adapted to be arranged in a cartridge based drug delivery device between a rotatable piston rod and a cartridge piston for capturing dose data from a dose expelling event, the sensor module (50) extending along a reference axis and comprising: a first module part (51) adapted to engage the cartridge piston and comprising anti-rotation means for establishing a frictional interface to the cartridge to impede rotation of the first module part (51) relative thereto, a second module part (54) adapted to engage the rotatable piston rod, and sensor means (52, 152, 252; 53, 153, 253) adapted to detect an extent of relative rotational motion between the first module part (51) and the second module part (54), wherein the anti-rotation means comprises a plurality of radially outwardly projecting studs (51.1; 351.1; 451.1), each comprising a contact surface (51.8; 351.8; 451.8, 451.9) adapted to establish frictional contact with an interior surface of the cartridge.

Abstract: A method of assembling a drug delivery device, comprising the steps of: inserting a piston rod in a nut portion of a cartridge assembly and rotating the piston rod until the piston rod distal end engages the cartridge piston, mounting a drive member on the piston rod in a rota-tional position being closest to a pre-determined rotational position, and rotating the drive member to the pre-determined rotational position.

Abstract: The present invention provides a sensor module (50) adapted to be arranged in a cartridge based drug delivery device between a rotatable piston rod and a cartridge piston. The sensor module (50) comprises a first sensor structure (52, 152, 252, 352) adapted to be at least substantially rotationally locked with respect to the cartridge piston and comprising a transversal sensor surface (52.2, 152.2, 252.2, 352.2), and a second sensor structure (53, 153, 253, 353) adapted to be rotationally locked with respect to the piston rod and comprising one or more flexibly supported and axially deflectable contact members (53.1, 53.2, 153.2, 253.2, 353.1, 353.2), which are positioned distally of the transversal sensor surface (52.2, 152.2, 252.2, 352.2) and are adapted to apply a proximally directed force thereto. The first sensor structure (52, 152, 252, 352) and the second sensor structure (53, 153, 253, 353) are adapted to undergo relative rotational motion, whereby the one or more contact members (53.1, 53.2, 153.

Abstract: The present invention is in the therapeutic field of drugs for medical conditions relating to diabetes. More specifically the invention relates to insulin analogues of human insulin. The invention provides pharmaceutical compositions comprising such insulin analogues and the uses if the such analogues for the treatment or prevention of medical conditions relating to diabetes.

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: 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: An add-on logging device (100, 300) mounted to a drug delivery device is turned on when the cap is removed. After a given amount of time in inactivity the sensor means of the add-on device is turned off automatically to save energy. If the user takes a dose of drug this is not detected as the add-on device is only turned on when the cap is removed. According to the present invention a warning message is provided when the cap is re-mounted after the sensor means has been turned off automatically, the warning message indicating to a user that an expelled dose may not have been detected.