Abstract: Provided herein are IL-2 muteins, IL-2 mutein Fc-fusion molecules, anti-IL-2 antibodies, and complexes comprising an anti IL-2 antibody bound to an IL-2 cytokine that preferentially expand and activate T regulatory cells and are amenable to large scale production. Also provided herein are variant human IgG1 Fc molecules lacking or with highly reduced effector function and high stability despite lacking glycosylation at N297. Also provided herein are linker peptides that are glycosylated when expressed in mammalian cells. Also provided herein are methods of making and using the compositions of the present invention.

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 arr methods for making and using GDF15 molecules.

Abstract: The invention provides modified apelin polypeptides having increased stability, circulating half-life, and/or potency relative to the native apelin-13 polypeptide. Compositions comprising the modified apelin polypeptides and methods of using the polypeptides for treating cardiac disorders, such as heart failure, are also disclosed.

Abstract: This disclosure related to antagonistic dual receptor antigen-binding proteins, e.g. antibodies and methods of using the dual receptor antibodies for treatment of pathological diseases. The dual receptor antibodies may comprise an antibody to ActRII receptors and may be used to treat pathological condition. The pathological conditions can comprise muscle wasting diseases or any disease that requires stimulation of muscle growth.

Abstract: Disclosed herein is a salt, a crystalline anhydrous form, a hydrate, a solvate, or a co-crystal of a free base compound 2-(6-azaspiro[2.5]octan-6-yl)-N-[2-(4,4-difluoropiperidin-1-yl)-6-methylpyrimidin-4-yl]-4-[(2-hydroxyethanesulfonyl)amino]benzamide (Compound A); method of preparation, pharmaceutical compositions, and method of treating a disease mediated by a motor protein kinesin family member 18A (KIF18A) inhibition, wherein said disease is a neoplastic disease, including a cancer or a tumor.

Abstract: A drug delivery device includes a housing defining a shell having a proximal and a distal end, a needle assembly at least partially disposed within the housing at the proximal end, a drive assembly at least partially disposed within the housing, and a damper mechanism at least partially disposed within the housing adjacent to the distal end. The housing further defines a longitudinal axis extending between the proximal end and the distal end. The needle assembly includes a syringe barrel containing a medicament and a needle or a cannula. The drive assembly is operably coupled to the needle assembly to urge the medicament through the needle or cannula. The damper mechanism is operably coupled to the drive assembly and the housing. Upon activating the drive assembly, the damper mechanism dampens an effect thereof.

Abstract: Systems, and methods that facilitate the performance of an assay of a sample substantially in real-time. Thus, the assay can be performed, and the desired result obtained, much more quickly than allowed by conventional systems and methods.

Abstract: Provided herein are excipients capable of effectively reducing the viscosity of polypeptide (e.g., therapeutic polypeptide) formulations. The viscosity reducing excipients are dipeptides containing arginine at the carboxy terminus and N-acetylated serine or N-acetylated proline at the N-terminus. Glutamate-arginine is also disclosed as a viscosity-reducing dipeptide. Among the disclosed methods, methods of reducing the viscosities of such formulations are also provided.

Abstract: Drug delivery devices and related arrangements are disclosed. A drug delivery device may include a housing having an opening, a drug storage container including a delivery member with an insertion end configured to extend at least partially through the opening, and a plunger. A drive mechanism may be included for driving the plunger in a distal direction to expel a drug from the drug storage container through the delivery member upon activation. The drug delivery device may additionally include a guard moveably disposed adjacent to the opening and operably coupled to the drive mechanism for activation of the drive mechanism. A lock may be selectively engageable with the guard to limit movement of the guard in the proximal direction. An indicator may be coupled to the drive mechanism to generate an audible signal during drug delivery, and to cease generating the audible signal when drug delivery is complete.

Abstract: Compounds of formula (I): as defined herein, and synthetic intermediates thereof, which are capable of modulating KIF18A protein thereby influencing the process of cell cycle and cell proliferation to treat cancer and cancer-related diseases. The invention also includes pharmaceutical compositions, including the compounds, and methods of treating disease states related to the activity of KIF18A.

Abstract: Disclosed herein are methods for removing at least one viral contaminant from a concentrated composition, comprising filtering the concentrated composition through a virus prefilter and a virus filter over one or more filtration cycles, wherein a ratio of the virus prefilter area to the virus filter area in each filtration cycle is at least about 2:1, as well as viral filtration skids for use in such methods.

Abstract: Disclosed herein are methods for purifying a recombinant protein from a composition comprising the recombinant protein and at least one impurity, the methods comprising performing anion exchange chromatography (e.g., in flow-through or weak partitioning chromatography mode) using an anion exchange material comprising a primary amine ligand, such as a polyamine ligand.

Abstract: The present disclosure provides diagnostic methods, that may be combined with medical treatment, using one or more plasma biomarkers that are useful for identifying a subject with Hidradenitis Suppurativa (HS), measuring disease severity of HS, and measuring clinical response in subjects with HS.

Abstract: Provided herein are myeloid cell leukemia 1 protein (Mcl-1) inhibitors, methods of their preparation, related pharmaceutical compositions, and methods of using the same. For example, provided herein are compounds of Formula I, and pharmaceutically acceptable salts thereof and pharmaceutical compositions containing the compounds. The compounds and compositions provided herein may be used, for example, in the treatment of diseases or conditions, such as cancer.

Abstract: A method for sampling images includes receiving a first image set generated by automated imaging equipment during a first inspection period, and storing in a memory an image library that initially consists of the first image set. A plurality of new image sets is then sequentially received (302) during respective inspection periods. While the new image sets are received (302), the image library stored in the memory is updated. Updating the image library includes, for each new image set, adding to the image library a certain number of images distributed among the new image set and removing from the image library the same number of images distributed among a current instance of the image library (308). The number of overwritten images in the image library decreases from one inspection period to the next.

Abstract: This invention relates to recombinantly-expressed denosumab molecules and methods for modulating glycan profiles of denosumab molecules.

Abstract: Provided herein are KRAS G12C inhibitors, such as composition of the same, and methods of using the same. These inhibitors are useful for treating a number of disorders, including pancreatic, colorectal, and lung cancers.

Abstract: The present disclosure provides compounds useful for the inhibition of KRAS G12D, G12V, G12A, G12S, G13D, Q61H, Q61L or G12C. The compounds have a general Formula I?: wherein the variables of Formula I? are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.

Abstract: Methods of fingerprinting a specific molecule in a composition using nuclear magnetic resonance (NMR) is disclosed. The disclosed NMR methods provide several modifications and improvements over existing NMR techniques. In some embodiments, the methods include applying a cycle of signal processing steps, including applying a radio frequency (RF) pulse, applying a gradient pulse having a pulse length less than or equal to 1000 ?s, and applying a water suppression technique (WET). In some embodiments, the methods further include repeating the cycle for at least 3 times to acquire an enhanced signal of the composition. In some embodiments, the methods further include fingerprinting the specific molecule based on the enhanced signal of the composition.

Abstract: Drug delivery devices are configured to include a gas-driven piston assembly having a flexible pushrod, a non-linear guide include a non-linear guide pathway at least partially surrounding the flexible pushrod, a cylinder at least partially surrounding the flexible pushrod, and a piston movable within the cylinder in response to the pressurized gas entering the cylinder. Some arrangements include a roller pushrod guide system and/or a gear pushrod guide system.