Abstract: The invention provides methods of detecting transthyretin (TTR) using a capture antibody and a reporter antibody. The capture antibody binds preferentially to misfolded TTR over native tetrameric form of TTR. The capture antibody binds to an epitope within amino acid residues 89-97 or TTR or to an epitope within amino acid residues 101-109 of TTR. 9D5 and 18C5 are examples of suitable capture antibodies. The methods can be used for diagnosing diseases or disorders associated with TTR accumulation or accumulation of TTR deposits (e.g., TTR amyloidosis) and for monitoring the efficacy of TTR therapies, among other applications.

Abstract: A device, system and method is provided for predicting risk of hypoglycemia and adjusting an insulin medicament dose size for a subject being on pen based multi-daily injections. A first algorithm is provided for computing a first insulin dose size based on a plurality of timestamped blood glucose (BG) measurements and insulin injected dose sizes. A risk prediction module is adapted to, based on machine learning algorithms, predict risk of hypoglycemia based on the timestamped BG measurements and calculate a second insulin dose size resulting in a non-hypoglycemic state. In case the second dose size is lower than the first dose size, the first dose size is automatically adjusted down to the second dose size and communicated as the recommended dose size to the subject.

Abstract: A drug delivery assembly comprising a magnetic indicator and a sensor system is provided. The indicator is arranged to rotate and move axially relative to a housing component and corresponding to a reference axis, the amount of rotation being indicative of the size of an expelled dose amount. The sensor system comprises a sensor component adapted to measure a property of the indicator indicative of a rotational position and/or a rotational movement of the indicator. The sensor component forms part of release assembly adapted to be moved into engagement with a release member to release a set dose, and subsequently to move axially together with indicator.

Abstract: A drug delivery assembly comprising an indicator adapted to move during expelling of a dose amount of drug, the amount of movement being indicative of the size of the expelled dose amount, and electronic tracking sensor circuitry adapted to with pre-determined intervals to change the operative state from a sleep state to a low-power detection state and back to the sleep state. When in the detection state, the electronic sensor circuitry is adapted to detect motion of an activation component, and if motion of the activation component is detected, then change the operative state from the low-power detection state to a high-power measuring state in which the amount of motion of the indicator relative to the tracking means can be determined.

Abstract: The present invention relates to improved uses of glucagon-like peptide-1 (GLP-1) peptides in oral therapy.

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

Abstract: This invention relates to glucose-sensitive albumin-binding diboron conjugates. More particularly the invention provides novel diboron compounds, and in particular diboronate or diboroxole compounds, useful as intermediate compounds for the synthesis of diboron conjugates.

Abstract: The invention relates to a novel administration regime useful in the treatment of diseases or conditions where administration of insulin will be of benefit. In particular, the invention relates to a long-acting or ultra-long acting insulin for use in treating a disease or condition where administration of insulin will be of benefit, wherein the administration of said insulin includes or consists of one or more of the following steps: (a) obtaining a first data set of the subject, (b) obtaining a second data set of the subject, (c) obtaining a first data structure of the subject, and (d) obtaining a second data structure of the subject. When a determination is made that the at least first data structure, second data structure, first data set, and second data set collectively do contain the set of evaluation information, the device further includes providing the long-acting or ultra-long-acting insulin dose guidance recommendation.

Abstract: The present invention provides a system (1) comprising: a pen injection device (10) holding a specific type of medicament and comprising a dose expelling mechanism and pen communication means (15), a mobile communication unit (30) comprising mobile communication means (35) adapted to communicate with the pen communication means (15), and a software application program configured to determine a recommended type of medicament to be delivered to a user based on information indicative of a physiological condition of the user, wherein the pen injection device (10) further comprises indication means which in a first state indicates that the dose expelling mechanism is to remain idle and in a second state indicates that the dose expelling mechanism is available for operation, and wherein the mobile communication unit (30) is configured to, via a communication from the mobile communication means (35) to the pen communication means (15), a) prompt a change of state of the indication means from the second state to the

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: 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 disclosure provides crystalline solid forms, spray-dried dispersions and pharmaceutical compositions, including solid oral dosage forms, of (S)-1-(5-[2H,3H-[1,4]dioxino[2,3-b]pyridine-7-sulfonyl]-1H,2H,3H,4H,5H,6H-pyrrolo[3,4-c]pyrrol-2-yl)-3-hydroxy-2-phenylpropan-1-one (“Compound 1”), and preparation methods thereof.

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: A flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) for establishing flow communication from a multi-use drug delivery device adapted for extended use, to a flow conducting device, wherein the drug delivery device comprises a reservoir comprising multiple doses of a liquid drug formulation, wherein the reservoir is adapted to pressurize the liquid drug formulation, wherein the flow conducting device (230) is adapted for conducting the drug to the subcutaneous tissue of a subject, wherein the flow communication unit is adapted for being in an unconnected and a connected configuration, whereby the flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) is adapted to enable the extended use of the multi-use drug delivery device.

Abstract: The present invention relates to a process for spray drying of a feed solution comprising semaglutide, said process comprising introducing the feed solution comprising semaglutide in a solvent into a spray dryer and introducing an atomising gas and a drying gas, characterised in that the spray dryer comprises a gas heater for the drying gas with an inner surface comprising iron and less than 18.5% chromium.

Abstract: The compound (S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one, or a pharmaceutically acceptable salt thereof, is useful to increase the affinity of hemoglobin for oxygen. Methods and compositions for the treatment of a hemoglobinopathies are provided herein, including certain pharmaceutical compositions for activating PKR.

Abstract: The invention relates to a bispecific antibody comprising a first antigen-binding site capable of binding Factor VII(a) and a second antigen-binding site capable of binding TLT-1, pharmaceutical formulations comprising such bispecific antibodies and uses thereof.

Abstract: A medical delivery device suitable for insertion into a lumen of a patient, the medical device (100, 200) comprising a capsule (110, 120, 210, 220) sized to be inserted into the lumen, the capsule comprising a base member, and an actuation mechanism comprising an actuation member (150, 250, 350) configured for movement relative to the base member along an axis, and an energy source (140, 240, 340) associated with the actuation member for powering the actuation member to move relative to the base member along the axis.