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: 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.

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: The present invention provides a compound of Formula I: wherein R1 is hydrogen or methyl; and R2 is: or a pharmaceutically acceptable salt thereof, useful for treating pain, including chronic pain, chronic lower back pain, diabetic peripheral neuropathic pain, and osteoarthritis pain.

Abstract: A medication delivery device having a lock element. The device is connectable to an electrical plug of a conduit. The device includes an external housing with an opening that ports to a plug receiving hollow within an interior volume. An electrical circuit connected to at least one of a rechargeable battery and a memory controller includes a connection element within the plug receiving hollow. The lock element travels within the plug receiving hollow when a dose delivery assembly of the device operates for forcing medication from the device. The lock element is sized and positioned to have its travel halted by abutment with the plug, when the plug is within the plug receiving hollow and electrically interfacing with the connection element, to thereby halt the dose delivery assembly from further operating for forcing medication from the device.

Abstract: Medication delivery devices are provided having a dose delivery sensing capability. A sensed element is attached to a dose setting member of the device. The sensed element includes surface features radially-spaced from one another. A rotational sensor is attached to an actuator of the device. The rotational sensor includes a movable element that is contactable against the surface features. The rotational sensor is configured to generate a signal in response to the movement of the movable element over the surface features during their rotation. A controller is operatively coupled to the rotational sensor, and in response to receiving the generated signal, the controller is configured to determine a number of the surface features passing the movable element of the rotational sensor during dose delivery. The number can be associated with an amount of dose delivered. Sensing can be provided in a module or integrated in device.

Abstract: Novel selective estrogen receptor degraders (SERDs) according to the formula: and pharmaceutically acceptable salt thereof and pharmaceutical compositions thereof, wherein R is selected from

Abstract: Solid forms including 7-[[(1S)-1-[4-[(1S)-2-cyclopropyl-1-(4-prop-2-enoylpiperazin-1-yl)ethyl]phenyl]ethyl]amino]-1-ethyl-4H-pyrimido[4,5-d][1,3]oxazin-2-one and a dihydroxybenzoic acid selected from 2,5-dihydroxybenzoic acid, 2,4-dihydroxybenzoic acid, and 2,3-dihydroxybenzoic acid are provided, as well as pharmaceutical compositions including the solid forms, methods for using the solid forms in treating cancer patients, and methods of making the solid forms.

Abstract: The present invention provides compounds of the formula: where R1, R2, R3, R4, R5, A, B, and Y are as described herein, pharmaceutically acceptable salts thereof, and methods of using these compounds and salts for treating patients for cancer.

Abstract: A vial adaptor and needle assembly are disclosed for use with a vial containing a medication, such as insulin. The vial adaptor may include a needle opening configured to receive a needle of a geometrically corresponding needle assembly to withdraw the medication from the vial in a secured manner. The vial adaptor may also include a cleaning passageway configured to receive a cleaning device to clean the vial.

Abstract: Provided herein are methods and compositions for overcoming Low Endotoxin Recovery (LER) and unmasking endotoxins. The compositions and methods provided herein may be used to prepare samples such as drug products for endotoxin testing.

Abstract: Disclosed herein are compounds of formula I: or a pharmaceutically acceptable salt thereof, where the variables are as defined herein. These compounds are useful in treating RET associated cancers. Formulations containing the compounds of formula I and methods of making the compounds of formula I are also disclosed.