Abstract: A drug delivery device (100) for delivering an amount of medicament comprising a housing and a medicament reservoir (135) with a piston (136). The device further comprises a ratchet mechanism comprising a first and a second set of movable and stationary ratchet members (281, 381, 481, 165.1, 365.1) adapted to provide a first and a second plurality of periodic audible signals, during the expelling of medicament. The ratchet mechanism is further adapted for generating the first and second plurality of periodic signals out-of-phase, whereby each of the signals are distinguishable by a user. The ratchet mechanism further comprises means to provide a radial force to counteract influence from radial play, which otherwise may generate variation in the frequency.

Abstract: A cartridge holder assembly is provided, comprising an enclosed cartridge, a distal portion and a proximal portion. The enclosed cartridge defines a longitudinal axis and comprises a generally cylindrical main portion, a distal outlet portion having a neck portion with a circumferential shoulder portion, and a proximal portion having an opening surrounded by a circumferential rim. The distal portion comprises a distal support structure engaging the cartridge neck portion and being adapted to support the cartridge against movement in the distal direction, and the proximal portion comprises a proximal support structure engaging the cartridge circumferential rim and being adapted to support the cartridge against movement in the proximal direction. The proximal support structure is essentially non-deformed, and the distal support structure engaging the cartridge neck portion is plastically deformed.

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

Abstract: Oligonucleotides are provided herein that inhibit MARC1 expression. Also provided are compositions including the same and uses thereof, particularly uses relating to treating diseases, disorders and/or conditions associated with MARC1 expression.

Abstract: The present invention provides a power unit (1) for a drug delivery device as well as methods for providing and mounting the power unit (1) in the drug delivery device. The power unit (1) comprises a first interface member (30) extending along a reference axis and comprising a hollow body (31) and a first engagement structure (35), a second interface member (10) comprising a tubular structure (11) extending at least partially through the hollow body (31) and having a skirt (12), and a second engagement structure (14) configured for releasable engagement with the first engagement structure (35), and a torsion spring (20) comprising a first end portion (23) being attached to the first interface member (30) and a second end portion (22) being attached to the second interface member (10), the torsion spring (20) being pre-strained to induce a relative rotational motion between the first interface member (30) and the second interface member (10).

Abstract: The present invention relates to novel covalently linked bi-functional fusion proteins comprising insulin and EGF(A) analogues or derivatives thereof, and their pharmaceutical use. Furthermore, the invention relates to pharmaceutical compositions comprising such bi-functional compounds, and to the use of such compounds for the treatment or prevention of medical conditions relating to diabetes and dyslipidaemia associated with diabetes.

Abstract: The present invention concerns a drug delivery device (1) comprising: a housing (2) extending along a main axis, a torsion spring (5) comprising a first spring end (4) arranged stationarily with respect to the housing (2) and a second spring end (6) capable of rotation about the main axis, a rotatable shaft (80) extending along the main axis, the rotatable shaft (80) having a non-self-locking thread (81) and being axially fixed with respect to the housing (2), a spring end retainer (82) to which the second spring end (6) is attached, the spring end retainer (82) being rotationally fixed relative to the rotatable shaft (80), and a nut member (45) engaged with the non-self-locking thread (81), the nut member (45) being axially movable by translation relative to the housing (2) to thereby travel the non-self-locking thread (81) between a first position in which the torsion spring (5) is in a relaxed state and a second position in which the torsion spring (5) is in a strained state.

Abstract: The present invention relates to novel peptides that are derivatives of glucose-dependent insulinotropic polypeptide (GIP) analogues having improved physical stability in solution and a protracted profile of action. More particular the invention relates to such peptides that are agonists at the GIP receptor and to their use in weight management or for treatment of diseases such as obesity, diabetes or non-alcoholic steatohepatitis (NASH).

Abstract: Peptide co-agonists of the human GLP-1 and GIP receptors suitable for oral delivery, including long-acting derivatives, and their medical use in treatment and/or prevention of obesity, diabetes, and/or liver diseases are described.

Abstract: A plunger sub-assembly (40, 60, 70; 80) for a pre-filled medicament injector for expelling a dose of a medicament, comprising: a) a container (60) holding a medicament, the container (60) comprising a body (61) with a proximally facing rim surface (64), and a distally slideable piston (63); b) a plunger (40); and c) a tolerance compensating element (70; 80) configured to cooperate with the plunger (40) and to cooperate with either the proximally facing rim surface (64) or the piston (63), the tolerance compensating element (70; 80) being rotatable relative to the plunger (40) to adjust the piston (63) end of dose position. The plunger sub-assembly (40, 60, 70; 80) is formed so that end of dose state occurs by the plunger (40) cooperating with the proximally facing rim surface (64). Pre-filled medicament injectors and methods of assembling a pre-filled medicament injector are further described.

Abstract: The invention provides antibodies that specifically bind to transthyretin (TTR). The antibodies can be used for treating or effecting prophylaxis of diseases or disorders associated with TTR accumulation or accumulation of TTR deposits (e.g., TTR amyloidosis). The antibodies can also be used for diagnosing TTR amyloidosis and inhibiting or reducing aggregation of TTR, among other applications.

Abstract: Systems and methods are provided for optimizing short acting insulin medicament dosage timing relative to a meal event for a subject. Glucose measurements of the subject over a time course and the timing of the measurements are obtained. Meal events in the time course and information regarding when dosages were injected into the subject relative to the meal events is obtained. Bins, each for a different time range for when a dosage is injected relative to a meal event, are constructed. Each bin is assigned glucose measurements in one or more periods within the time course in which the subject injected the dosage within the time range associated with the bin. A glycaemic risk measure is determined for each bin with the assigned measurements and used to identify an optimal relative time range for the subject. This is communicated to a health care practitioner or to the subject.

Abstract: The invention relates to pharmaceutical compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. The invention further relates to processes for the preparation of such compositions, and their use in medicine.

Abstract: An add-on device for a drug delivery device comprises a camera for capturing an image of a scale drum, and a processor for determining the value of a captured image using a first image analysis process, the value corresponding to a set dose amount. If the determined value belongs to a pre-defined group of values, the determined value is confirmed using a second image analysis process in which for a given value from the pre-defined group of values one or more partial image areas and an associated nominal content thereof are pre-defined. If the captured content for each image area corresponds to the nominal content, the determined value is confirmed.

Abstract: The present invention relates to a process for spray drying of a feed solution comprising the GLP-1 peptide semaglutide wherein the ratio of atomising gas flow (kg/h) to feed solution flow (kg/h) is 1.0-1.7.

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. The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage with a surface. 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). In some cases, upon contact of the tissue with the tissue engaging surface of the article, the self-righting article may be configured to release one or more tissue interfacing components.

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: 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.