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 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 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.

Abstract: The disclosure provides novel chemical compounds useful as activators of PKR. PKR activating compounds are useful in the treatment of disease and disorders associated with modulation of PKR and/or PKM2, such as pyruvate kinase deficiency (PKD).

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: An ingestible device may include one or more deployable limbs configured to orient the ingestible device in a desired orientation. The one or more limbs may be attached to body of the device and wrap around the device in an initial configuration (e.g., prior to deployment of the one or more limbs). The one or more limbs may be configured to deploy when exposed to a predetermined condition. Once the predetermined condition is met, the one or more limbs may extend outwards away from the body such that the one or more deployed limbs serve to orient the ingestible device.

Abstract: Antibodies that are capable of specifically binding and preventing the activation of TREM-1, a protein expressed on monocytes, macrophages and neutrophils with both good affinity and low viscosity at clinically relevant concentrations are described. Such antibodies find utility in the treatment of individuals with an inflammatory disease, such as rheumatoid arthritis and inflammatory bowel disease.

Abstract: The invention relates to a compound comprising an amylin receptor agonist. The invention also relates to a pharmaceutical composition, suitable for but not limited to oral administration, which comprises such a compound. The compound and pharmaceutical composition comprising it may be used for the medical treatment of subjects with overweight, obesity and associated co-morbidities.

Abstract: A drug delivery device includes a dose counting mechanism and an end-of-content or remaining-dose indication. For example, a dose expelling mechanism is coupled to a reciprocating element configured to undergo a predefined motion during each dose expelling action to allow a dose to be expelled. The predefined motion includes displacement in a first axial direction from a first position to a second position followed by displacement in a second axial direction from the second position to the first position, with a counter element being movable in the first axial direction. First and second unidirectional ratchet mechanisms prevent motion in the first axial direction and allow motion in the second axial direction of the reciprocating element relative to the counter element, and vice versa, respectively.

Abstract: Systems and methods are provided for adjusting long acting insulin medicament dosages for a subject. A plurality of timestamped glucose measurements of the subject is obtained. A titration glucose level (246) is computed as a measure of central tendency (244, 268, 274) of a titration subset of small glucose measurements (240, 269, 273) identified within the timestamped glucose measurements, wherein the measure of central tendency represents a measure of small glucose measurements for the primary time window. A long acting insulin medicament dosage (216) is adjusted or maintained based upon the obtained titration glucose level (246).

Abstract: The invention relates to a torsion spring driven injection device for ejecting set doses of a liquid drug. In a first aspect the torsion spring driven injection device is provided with a blocking structure which is operated by the rotatable display element such that the set dose can only be expelled when a certain minimum dose size has been set. In a second aspect the torsion spring driven injection device is provided with a release mechanism which secures that the set dose can only be expelled as one single full dose in one stroke. The two aspects can easily be combined such that the predetermined minimum dose size most be expelled as one single dose.

Abstract: A drug delivery device for administration to a subject is provided. In some embodiments, the drug delivery device includes a reservoir containing an active pharmaceutical ingredient and a potential energy source. The drug delivery device also includes a trigger operatively associated with the potential energy source, where the trigger is configured to actuate at a predetermined location within the subject. The drug delivery device also includes a rupturable membrane disposed along a flow path extending between the reservoir and an outlet, where the membrane is configured to rupture when the trigger is actuated. Once the trigger is actuated, the potential energy from the potential energy source may be released to expel the active pharmaceutical ingredient in a jet through the outlet.

Abstract: The present invention provides ISVD polypeptide derivatives capable of binding coagulation Factor IX(a) and Factor X(a) which are highly potent and provide a sufficiently long half-life such to allow for effective subcutaneous—as well as peroral administration. The ISVD polypeptides derivatives disclosed herein are thus suitable for treatment of haemophilia A, haemophilia A with inhibitors and acquired haemophilia A by various routes of administration including subcutaneous and peroral administration.

Abstract: The present disclosure relates to a method of treating non-alcoholic steatohepatitis (NASH) comprising administering to a subject with NASH a combination therapy comprising semaglutide, firsocostat, and/or cilofexor.

Abstract: A drug delivery device (100, 300) for delivering a medicament, wherein the device comprises an insertion controlled needle cannula (224, 424), wherein the drug delivery device comprises: a retaining structure (130, 136, 350, 430) axially locked to the housing and adapted for retaining the hub (225, 425) in the proximal position, a pulling structure (230, 320) axially locked to the shield (110, 310) and adapted for being disengaged from the hub (225, 425), in a decouple state, whereby the pulling structure is movable relative to the hub (225, 425), and wherein the pulling structure (230, 320) is further adapted for engaging the hub, in a coupled state, whereby the pulling structure is movable together with the hub, wherein the retaining structure and the pulling structure are operatively connected to the shield (110, 310) and the needle assembly (220, 420) in the active position.

Abstract: The present invention relates to improved procoagulant antibodies including bispecific antibodies capable of binding to coagulation Factor IX (FIX) or the activated form thereof Factor IXa (FIXa) and optionally Factor X (FX) and the activated form thereof Factor Xa (FXa) and promoting FX activation by FIXa, antibodies binding their epitopes and methods and composition for treating subjects suffering from a coagulopathy such as haemophilia A.

Abstract: This application relates to new C-type natriuretic peptide (CNP) compounds, pharmaceutical compositions comprising these compounds, and these compounds for use as medicaments.