Abstract: GDF15 molecules are provided herein. In some embodiments, the GDF15 molecule is a GDF15-Fc fusion, in which a GDF15 region is fused to an Fc region. In some embodiments, the GDF15 region is fused to the Fc region via a linker. Also, provided herein are methods for making and using GDF15 molecules.

Abstract: A liquid formulation comprising a peptide agonist of the calcium sensing receptor and method of preparing and using the formulation are provided.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: The present disclosure relates to a method for detecting T helper cell or CTL subpopulations in a subject affected by disease or disorder having an immune component. The methods are also useful for determining efficacy of a treatment of the disease or disorder by detecting skewing of the T helper cells and CTLs in a therapeutic or adverse direction.

Abstract: A drug delivery device includes a housing defining a shell comprising a front portion and a rear portion slidably coupled to the front portion, a drug delivery assembly at least partially disposed within the housing, at least one electronic component, a power source which powers the electronic component, and a switch assembly. The switch assembly is adapted to selectively cause the power source to provide power to the at least one electronic component.

Abstract: The present application relates to K-ras mutations, to polynucleotides encoding mutant K-ras polypeptides, and to methods of identifying K-ras mutations. The present application also relates to methods of diagnosing cancer; and methods and kits for predicting the usefulness of anti-EGFr specific binding agents in the treatment of tumors.

Abstract: The present invention relates to production of autologous genetically engineered T cells for use in cell therapy applications.

Abstract: The present invention relates to a method for enhancing production of autologous genetically engineered T cells for use in cell therapy applications.

Abstract: The application concerns tissue inhibitor of metalloproteinase 3 (TIMP-3) muteins, variants and derivatives, nucleic acids encoding them, and methods of making and using them; in particular, muteins of TIMP-3 with specific amino acid substitutions in order to introduce N-linked glycosylation sites.

Abstract: Compounds of Formula I, pharmaceutically acceptable salts thereof, tautomers thereof, pharmaceutically acceptable salts of the tautomers, or mixtures thereof are agonists of the APJ Receptor and may have use in treating cardiovascular and other conditions. Compounds of Formula (I) have the following structure: where the definitions of the variables are provided herein.

Abstract: This invention relates to combination therapies comprising a Programmed Death 1 receptor (PD-1) pathway inhibitor, and a Leukocyte Immunoglobulin Like Receptor B (LILRB) signaling inhibitor, and the use of the combination therapies for the treatment of cancer. The invention also relates to the treatment of cancer patients who are refractory to monotherapy with a PD-1 pathway inhibitor.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product, including a granulocyte colony-stimulating factor (G-CSF). The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.

Abstract: Methods of modulating high mannose glycoform content of a protein in a cell culture by contacting the cells expressing the protein of interest with monesin are provided.

Abstract: Antigen binding molecules, chimeric receptors, and engineered immune cells to STEAP1 are disclosed in accordance with the invention. The invention further relates to vectors, compositions, and methods of treatment and/or detection using the STEAP1 antigen binding molecules and engineered immune cells.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: An insertion mechanism for a wearable drug delivery device includes a needle hub, a needle coupled to the needle hub, a flexible boot removably coupled to the needle hub, and a cannula coupled to the flexible boot. The needle hub, the needle, the flexible boot, and the cannula are movable between a first position and a second position. Upon moving the needle hub, the needle, the flexible boot, and the cannula from the first position to the second position, the cannula engages a floor member to restrict movement of the cannula and the flexible movement towards the first position.

Abstract: The present invention concerns antigen binding proteins that bind TL1A, including bispecific antigen binding proteins (e.g., antibodies) to TL1A and TNF-?. Such bispecific antibodies can be in a tetrameric immunoglobulin format, in which one heavy chain-light chain pair of the antibody is directed to TL1A and the other to TNF-?. The bispecific antigen binding proteins may also be comprised in an IgG-scFv fusion, in which a conventional tetrameric antibody directed to one antigen is fused to a pair of single chain Fv units directed to the other. The bispecific antigen binding protein may also be comprised in an IgG-Fab fusion, in which a Fab molecule that binds to one antigen is fused to each heavy chain of a conventional tetrameric antibody directed to the other antigen. The invention further relates to uses of the anti-TL1A binding proteins and anti-TL1A/anti-TNF-? antigen binding proteins, and pharmaceutical formulations thereof.

Abstract: Methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced antigen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced antigen-binding protein molecules. Formulations comprising a re-oxidized antigen-binding protein are also described.

Abstract: An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a medical fluid or drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. The sterile container needle is attached to a connector, the connector mechanically coupled to the container to secure the sterile container needle to the container with the needle in the storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.