Abstract: The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.

Abstract: The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.

Abstract: An assembly comprising a drug delivery device and an add-on device adapted to be releasably mounted thereon, the drug delivery device comprising a rotatable dose setting member with an outer surface and at least one axially oriented drive groove. The add-on device comprises a drive portion adapted to be mounted in engagement with the dose setting member and comprises a drive structure adapted to engage a drive groove and being biased in a radially inwards direction. This arrangement allows the drive structure to rotationally slide on the dose setting member outer surface and into engagement with the drive groove(s).

Abstract: The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.

Abstract: The invention relates to a construct comprising a compound targeting areas in the brain involved in the regulation of body weight and an allosteric ligand to a receptor located in the blood-brain barrier (BBB). The invention also relates to compositions and uses of such construct, for example in the prevention or treatment of overweight and obesity. Preferred compounds for regulation of body weight include GLP-1 receptor agonists (GLP-1RA), and preferred receptors located in the BBB include the transferrin receptor (TfR). Exemplary fusions and conjugates of GLP-1 RA's and anti TfR-Fab's exhibit an increased binding to brain regions expressing the GLP-1 receptor as compared to fusions or conjugates with inactive control Fab's, in particular in brain areas protected by the BBB. In vivo mice studies confirm increased reduction in food intake as well as weight loss for the active construct compared to the inactive one.

Abstract: A drug delivery device for administration to a subject may include a reservoir containing an active pharmaceutical ingredient and a potential energy source. The drug delivery device may also include a trigger operatively associated with the potential energy source. The trigger may be configured to actuate at a predetermined location within the subject to deploy a jet of the active pharmaceutical ingredient into a tissue of an adjacent portion of the gastrointestinal tract. In some instances, the jet may be deployed into tissue of the stomach and/or small intestine of the subject. Further, in some embodiments, the operating parameters of the jet may be selected such that the jet penetrates the tissue of the gastrointestinal tract to form a depot of the active pharmaceutical ingredient disposed within the tissue.

Abstract: The current invention relates to the treatment of diseases characterized by cartilage destruction and/or bone erosion. In particular the present invention relates to the treatment of osteoarthritis, osteoporosis, psoriatic arthritis or rheumatic arthritis with an anti-NKG2A antibody.

Abstract: A drug delivery system comprises an indicator element and a sensor system. The indicator element is arranged to rotate relative to a reference component and corresponding to a reference axis and comprises a plurality of dipole magnets. The sensor system comprises a plurality of magnetometers arranged non-rotational relative to the reference component and adapted to determine continuous magnetic field values from the plurality of dipole magnets, as well as processor means configured to determine on the basis of measured values from the plurality of magnetometers a rotational position and/or a rotational movement of the indicator element.

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: 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 relates to insulin degludec for use in medicine.

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: 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 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: 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: 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: 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: 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.