Abstract: Chromatographic method for separation of AAV capsid proteins using hydrophilic-interaction chromatography (HILIC). The method provides the ability to quantify capsid protein ratio and to separate capsid proteins to the extent that low level post-translational modifications (PTMs) can be detected by mass spectrometry.

Abstract: The present invention relates to a method of identifying a metastatic tumor determined to have a mutation in homologous recombination pathway genes, that is sensitive to treatment with talazoparib, or a pharmaceutically acceptable salt thereof, and methods of treatment thereof, comprising a) determining a homologous recombination deficiency score from a biopsy of the metastatic tumor; and b) administering talazoparib, or a pharmaceutically acceptable salt thereof, if the homologous recombination deficiency score is at least 33%, wherein the mutation is not germline BRCA1 or germline BRCA2. The present invention also relates to a method of selecting a subject determined to have a metastatic tumor with a mutation in homologous recombination pathway genes, for treatment with talazoparib, or a pharmaceutically acceptable salt thereof.

Abstract: Apixaban pharmaceutical formulation is provided. Also provided is a use of the apixaban formulation in treatment of a thromboembolic disorder.

Abstract: This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.

Abstract: This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.

Abstract: Provided herein are 6-carboxylic acids of benzimidazoles and 4-aza-, 5-aza-, 7-aza- and 4,7-diaza-benzimidazoles as GLP-1R agonists, processes to make said compounds, and methods comprising administering said compounds to a mammal in need thereof.

Abstract: The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.

Abstract: The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.

Abstract: The present invention provides a method for the treatment of a patient comprising administering to the patient an initial dose of between about 1 mg and about 150 mg of a MAdCAM antagonist antibody. Biomarkers for assessing a patient's response to anti-MAdCAM treatment are also provided.

Abstract: The present invention relates to antibodies, e.g., full length antibodies or antigen binding fragments thereof, that specifically bind to BCMA (B-Cell Maturation Antigen) and/or CD3 (Cluster of Differentiation 3). The invention also relates to antibody conjugates (e.g., antibody-drug-conjugates) comprising the BCMA antibodies, compositions comprising the BCMA antibodies, and methods of using the BCMA antibodies and their conjugates for treating conditions associated with cells expressing BCMA (e.g., cancer or autoimmune disease). The invention further relates to heteromultimeric antibodies that specifically bind to CD3 and a tumor cell antigen, (e.g., bispecific antibodies that specifically bind to CD3 and BCMA). Compositions comprising such heteromultimeric antibodies, methods for producing and purifying such heterodimeric antibodies, and their use in diagnostics and therapeutics are also provided.

Abstract: The present invention relates to antibodies that specifically bind to B7-H4 (B7 Homology 4, encoded by gene VTCN1) and bispecific antibodies that specifically bind to both B7-H4 and CD3 (Cluster of Differentiation 3), and polynucleotides, pharmaceutical compositions and methods and uses thereof.

Abstract: The invention relates to methods for producing an RSV F protein trimer in a fed batch cell culture.

Abstract: CD47+ disease cells such as cancer cells are treated using a combination of CD47 blocking agent and a CD38 antibody such as daratumumab. The anti-cancer effect of SIRP?Fc is enhanced in the presence of daratumumab. Specific combinations include SIRP?Fc forms that comprise an Fc that is either IgG1 or IgG4 isotype. These combinations are useful particularly to treat blood cancers including lymphomas, leukemias and myelomas.

Abstract: An injector, comprising a housing arranged along a longitudinal axis and configured to receive a medicament cartridge; an injection drive mechanism for driving a piston, the piston forming part of the medicament cartridge, the injection drive mechanism injecting a medicament when the piston is forwardly displaced; and a needle hiding element, which is slidably attached to the housing and positionable in at least one of an extended orientation and a retracted orientation, wherein in the extended orientation the needle hiding element protrudes forwardly from the housing and in the retracted orientation, the needle hiding element is locked relative to the housing.

Abstract: The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates) and uses thereof. Immunogenic compositions of the present invention will typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR®, SYNFLORIX® and/or PREVNAR 13®. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumococcal infections using said novel immunogenic compositions.

Abstract: IL-12 variants are provided. Also provided are antibodies that specifically bind to PD1. Also provided are fusion proteins of IL-12 variants and anti-PD1 antibodies. Also provided are uses of these IL-12 variants, anti-PD1 antibodies, fusion proteins, and related compositions and methods.

Abstract: Methods of administering a therapeutically effective amount of Debio 1143 and a therapeutically effective amount of an anti-PD-L1 antibody or antigen-binding fragment thereof, for the treatment of cancer, are provided.

Abstract: Self-amplifying RNA (saRNA) molecules encoding an influenza virus antigen and methods of use thereof are disclosed herein.

Abstract: Compounds of Formula I that inhibit the activity of the diacylglycerol acyltransferase 2 (DGAT2) and their uses in the treatment of diseases linked thereto in animals are described herein.