Abstract: A device for removing a protective shield such as a needle shield is disclosed. The device includes a cup shaped body with a sidewall, a distal bottom wall and a proximal opening. The protective shield is insertable into the cup shaped body through its proximal opening. Fingers are disposed opposite each other in openings in the sidewall. The fingers are flexibly coupled with the sidewall at a proximal end of the finger and can be resiliently biased inwardly to engage the protective shield. Each finger includes at least one projection for engaging the protective shield. The fingers may also include a distal engagement surface for engaging a lip on the protective shield.

Abstract: The present invention provides compounds of the formula: for use in the treatment of systemic sclerosis, fibrosis (e.g. pulmonary fibrosis), achondroplasia, thanatophoric dysplasia (e.g. type I), severe achondroplasia with developmental delay and acanthosis nigricans (SADDAN), muenke syndrome or cancer.

Abstract: Antibodies to human CD11d, compositions comprising such CD11d antibodies, and methods of using such CD11d antibodies for the treatment of central nervous system trauma including spinal cord injury and traumatic brain injury, as well as systemic inflammatory response following central nervous system trauma.

Abstract: The invention is a composition of human insulin or insulin analog that includes specific concentrations of citrate, chloride, in some cases including the addition of sodium chloride, zinc and, optionally, magnesium chloride and/or surfactant, and that has faster pharmacokinetic and/or pharmacodynamic action than commercial formulations of existing insulin analog products.

Abstract: A medication delivery device includes a disposable portion and a reusable portion. The disposable portion includes a therapeutic agent delivery assembly, and the therapeutic agent delivery assembly includes a needle. The therapeutic agent delivery assembly is translatable from a stowed configuration to a deployed configuration. The reusable portion includes a first rack and pinion mechanism and a second rack and pinion mechanism. The first rack and pinion mechanism is actuatable to translate the therapeutic agent delivery assembly from the stowed configuration to the deployed configuration. The second rack and pinion mechanism is actuatable to translate a plunger and thereby cause the therapeutic agent delivery assembly to deliver a therapeutic agent from the needle.

Abstract: The present disclosure relates to compounds that bind to human GITR, pharmaceutical compositions comprising such compounds, and methods of using such compounds.

Abstract: A medication delivery device including a device body and a dose setting component coupled to the device body. Component is rotatable relative to the device body in relation to an amount of a set or delivered dose. An annular sensed element, such as a metal or magnetic ring, is positioned on a proximal surface of the dose setting component. A carrier secures the sensed element to the dose setting component. The carrier includes a proximal overlapping support that is contactable against the sensed element opposite the proximal surface of the dose setting component. The carrier is configured to axially and rotationally fix the sensed element to the dose setting component. The device may include a dose detection system operable with the sensed element.

Abstract: An autoinjector may include a disposable portion and a reusable portion. The disposable portion may include a syringe and a syringe coupling. The syringe coupling may be coupled to the syringe, and may comprise a guide track. The reusable portion may include a device housing, a device actuator configured to initiate an injection of the autoinjector, and a motor coupled to the device actuator. The reusable portion may additionally include a motor foot coupled to an output of the motor, wherein the motor foot may be configured to translate in an axial direction. The reusable portion may also include a drive coupling disposed within the device housing. The drive coupling may include an angled surface configured to receive the motor foot and a protrusion configured to engage with the guide track of the syringe coupling to lock the drive coupling to the syringe coupling.

Abstract: Small molecule potentiatiors to potassium channels (such as Kv7 potentiators—which are also called KCNQ potentiators), compositions including such compounds, and methods of using such compounds for the treatment of Amyotrophic Lateral Sclerosis and other neurological diseases caused by changes in motor neuron excitability, including, but not limited to, primary lateral sclerosis, pseudobulbar palsy, progressive bulbar palsy, progressive muscular atrophy and epilepsy.

Abstract: The present invention provides a method of treating a tau-mediated cognitive or neurodegenerative disease, comprising administering to a patient in need of such treatment an effective amount of an anti-Tau antibody and an effective amount of an OGA inhibitor.

Abstract: The present invention relates to specific salts of (1S,5R)-(1?,5?,6?)-N-[1,1-dimethyl-2-[(3-methyl-2-pyridyl)oxy]ethyl]-3-azabicyclo[3.1.0]hexane-6-carboxamide, to pharmaceutical compositions comprising said salts, to methods of using said salts to treat physiological disorders, and to intermediates useful in the synthesis of the salts.

Abstract: Incretin analogs are provided that have activity at each of the GIP, GLP-1 and glucagon receptors. The incretin analogs have structural features resulting in balanced activity and extended duration of action at each of these receptors. Methods also are provided for treating diseases such as diabetes mellitus, dyslipidemia, fatty liver disease, metabolic syndrome, non-alcoholic steatohepatitis and obesity.

Abstract: The present invention provides medicaments for use in treating and methods of treating T-cell acute lymphoblastic leukemia, acute lymphoblastic leukemia, chronic lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, erythroleukemia, triple negative breast cancer, breast cancer, ovarian cancer, melanoma, Sung cancer, non small-cell lung cancer, pancreatic cancer, glioblastoma, colorectal cancer, head and neck cancer, cervical cancer, prostate cancer, liver cancer, oral squamous cell carcinoma, skin cancer, medul!ob!astoma, hepatocellular carcinoma, intrahepatic and extrahepatic cholangiocarcinoma, desmoid tumor, soft tissue sarcoma, or adenoid cystic carcinoma in a patient comprising combination therapy with 4,4,4-tri-fluoro-N-[(1S)-2˜[[(7S)-5-(2-hydroxyemyl)-6-oxo-7H-pyrido[23-d][3]benzazepin-7-yl]amino]-1-methyl-2-oxo-ethyljbutanamide, or a pharmaceutically acceptable salt or hydrate thereof, and a PD-1 or a PD-L1 inhibitor selected from pembrolizumab, nivolumab, atezolizumab, dur

Abstract: PYY analogs are disclosed that include modifications that increase half-life when compared to native, human PYY, as well as additional modifications that increase potency and selectivity to the NPY2 receptor. Pharmaceutical compositions also are disclosed that include one or more of the PYY analogs described herein in a pharmaceutically acceptable carrier. Methods of making and using the PYY analogs also are disclosed, especially for treating obesity and obesity-related diseases and disorders such as type II diabetes mellitus.

Abstract: Methods for producing Fabs and IgG bi-specific antibodies comprising expressing nucleic acids encoding designed residues in the CH1/CL interface are provided. Also provided are Fabs and IgG bi-specific antibodies produced according to the provided methods as well as nucleic acids, vectors and host cells encoding the same.

Abstract: Provided herein are polymorphs of (2E)-3-fluoro-2-({[2-(4-methoxypiperidin-1-yl)pyrimidin-5-yl]oxy}methyl)prop-2-en-1-aminium 4-methylbenzenesulfonate, compositions thereof, methods of preparation thereof, and methods of use thereof.

Abstract: The present disclosure provides methods and compositions relating to isolated CD8+ T cells expressing a disease antigen-specific T cell receptor, as well as nucleic acids encoding the V? and V? polypeptide pairs of T cell receptors (TCRs) of such disease antigen-specific T cells. Such disease antigen-specific CD8+ T cells are obtainable from the periphery (e.g., blood) of a subject having a disease amenable to treatment with an IL-10 agent. The present disclosure also contemplates therapeutic methods and compositions relating to administration of isolated disease antigen-specific CD8+ T cells to a subject, as well as therapeutic methods and compositions relating to CD8+ T cells genetically modified to express a disease antigen-specific TCR and/or chimeric antigen receptor.

Abstract: The present invention provides a compound of Formula I: wherein R is H or R1 is H, halogen, C1-C3 alkyl, C3-C6 cycloalkyl, C1-C3 alkoxy, C2-C3 alkenyl, OCF3, R2 is H, halogen, C1-C3 alkyl, C1-C3 alkoxy, or C2-C4 alkenyl; R3 is NH2, or CH2NH2; and X is O, OCH2, OCH2CH2, OCH(CH3), CH2O, SCH2, CH2S, CH2, NHCH2, CH2NH, N(CH3)CH2, CH2CH2, C?C, or a bond, wherein X is connected to phenyl ring A at the ortho or the meta position, or a pharmaceutically acceptable salt thereof, wherein the compound of Formula I, or pharmaceutically acceptable salt thereof is useful for treating autoimmune and inflammatory diseases, such as atopic dermatitis and rheumatoid arthritis.

Abstract: An injection device is disclosed including a housing assembly defining a pair of ramps and adapted to hold a medicament cartridge. A driver is adapted to advance the piston within the cartridge. A plunger having a pair of arms is moveable between a retracted position and an advanced position. Each of the arms are engageable with a respective one of the ramps as the plunger is advanced. A braking mechanism may include braking members on the arms and braking tracks proximate the ramps. Excessive force exerted on the plunger may flex the arms and engage the braking members with the braking tracks. The plunger arms may be connected together by a material bridge that biases the plunger arms apart from each other. The arms may include detents that engage to prevent the arms from moving due to the biasing force of the material bridge when the arms are in the fully retracted position.