Abstract: Compositions including solid forms of polypeptides such as crystalline antibodies, and related methods, are generally described. The compositions may include carriers such as hydrogels that at least partially encapsulate the solid form of the polypeptides (e.g., crystals, amorphous solids). Encapsulation with certain of the materials described may result in compositions containing relatively high loadings of polypeptides while in some instances retaining structural and functional properties of the polypeptides useful for certain types of administration to subjects (e.g., for prophylactic or therapeutic applications). In some instances, compositions having relatively low dynamic viscosities while having relatively high polypeptide loadings are provided.

Abstract: The present invention provides methods for making polysaccharide-protein conjugates in which polysaccharides, typically from bacteria, are conjugated to a carrier protein by reductive amination under conditions which improve conjugation reaction consistency, increase consumption of protein during conjugation reaction, generate conjugates of higher molecular weight, and/or reduce the levels of free cyanide in the conjugate reaction product. The polysaccharide-protein conjugates obtained using these methods are useful for inclusion in multivalent vaccines.

Abstract: Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided herein are compositions comprising antibodies or antigen binding fragments thereof that bind to cytotoxic T lymphocyte associated antigen 4 (CTLA4). In another aspect, such compositions further comprise a reduced level of host cell proteins and/or increased level of polysorbate-80 (PS-80) stability.

Abstract: The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API): wherein “Ra” is independently —H or —F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released.

Abstract: The present invention is directed to a process for preparing a compound of formula I-11 through multiple-step reactions:

Abstract: Novel compounds of the structural formula I, and the pharmaceutically acceptable salts thereof, are inhibitors of TarO and may be useful in the prevention, treatment and suppression of diseases mediated by TarO, such as bacterial infections, including gram negative bacterial infections and gram positive bacterial infections such as MRSA and MRSE, alone or in combination with a ?-lactam antibiotic.

Abstract: A method of treating metastatic pancreatic adenocarcinoma in a subject in need thereof is provided. The method comprising administering to the subject a therapeutically effective amount of each of a peptide set forth in SEQ ID NO: 1, an anti PD-1 and a chemotherapy, thereby treating the metastatic pancreatic adenocarcinoma.

Abstract: The present invention is directed to processes for preparing beta 3 agonists of Formula (I) and Formula (II) and their intermediates. The beta 3 agonists are useful in the treatment of certain disorders, including overactive bladder, urinary incontinence, and urinary urgency.

Abstract: The present invention relates to methods of treating cancer by administering an anti-CD27 antibody as a monotherapy or as a part of a combination thereof.

Abstract: The present invention relates to compositions comprising the compound niraparib, in particular certain solid forms of niraparib.

Abstract: Provided herein are high affinity antibodies or antigen binding fragments thereof that specifically bind to human tau-pS413. Also provided are compositions, kits, methods, and uses involving such antibodies or antigen binding fragments thereof.

Abstract: The application is directed to efficient and economical processes as described in more detail below for the preparation of the beta 3 agonists of the formula of I-7 and intermediate compounds that can be used for making these agonists. The present disclosure relates to a process for making beta-3 agonists and intermediates using ketoreductase (KRED) biocatalyst enzymes and methods of using the biocatalysts.

Abstract: Insulin-incretin conjugates comprising a peptide having agonist activity at the glucagon-like 1 (GLP-1) receptor, the glucagon (GCG) receptor, and/or the gastric inhibitory protein (GIP) receptor conjugated to an insulin molecule having agonist activity at the insulin receptor and use of the conjugates for treatment of metabolic diseases, for example, Type 2 diabetes, are described.

Abstract: In its many embodiments, the present invention provides certain 7-, 8-, and 10-substituted amino triazolo quinazoline derivatives of Formula (I): or a pharmaceutically acceptable salt thereof, wherein ring A, R1, R2, and R4 are as defined herein, pharmaceutical compositions comprising one or more such compounds (alone and in combination with one or more other therapeutic agents), and methods for their preparation and use, alone and in combination with other therapeutic agents, as antagonists of A2a and/or A2b receptors, and their use in the treatment of a variety of diseases, conditions, or disorders that are mediated, at least in part, by the adenosine A2a receptor and/or the adenosine A2b receptor.

Abstract: The present invention is directed to substituted certain N-(heteroaryl)quinazolin-2-amine derivatives of Formula (I): and pharmaceutically acceptable salts thereof, wherein J, R3, and R4, are as defined herein, which are potent inhibitors of LRRK2 kinase and may be useful in the treatment or prevention of diseases in which the LRRK2 kinase is involved, such as Parkinson's Disease and other diseases and disorders described herein. The invention is also directed to pharmaceutical compositions comprising these compounds and the use of these compounds and compositions in the prevention or treatment of diseases, such as Parkinson's disease, in which LRRK-2 kinase is involved.

Abstract: The present invention is directed to heteroaryl pyrrolidine and piperidine compounds which are agonists of orexin receptors. The present invention is also directed to uses of the compounds described herein in the potential treatment or prevention of neurological and psychiatric disorders and diseases in which orexin receptors are involved. The present invention is also directed to compositions comprising these compounds. The present invention is also directed to uses of these compositions in the potential prevention or treatment of such diseases in which orexin receptors are involved.

Abstract: Disclosed herein are compounds of formula (I) which are inhibitors of an IDO enzyme: (I). Also disclosed herein are uses of the compounds in the potential treatment or prevention of an IDO-associated disease or disorder. Also disclosed herein are compositions comprising these compounds. Further disclosed herein are uses of the compositions in the potential treatment or prevention of an IDO-associated disease or disorder.

Abstract: A dossier change control management system periodically ingests data regarding a regulated product from multiple data stores. The dossier change control management system updates dossier data describing a dossier history for the regulated product using the received data. The dossier includes multiple documents in a standardized format and is updated based on a data mapping indicating correspondence between fields of the documents and portions of the received data. An out-of-expectation scenario for the dossier is identified based on regulatory requirements and an alert generated. A report with information about the out-of-expectation scenario is provided for display at a client device based on the alert.

Abstract: Anti-cancer combination therapies comprising a CTLA-4 blocking agent and a PD-1 blocking agent are disclosed. In particular, combination therapies are disclosed wherein the CTLA-4 blocking agent is an effector-silent anti-CTLA-4 antibody or effector-silent anti-CTLA-4 antibody fragment and the PD-1 blocking agent is an anti-PD-1 or anti-PD-L1 antibody, or antibody fragment thereof.

Abstract: The present disclosure describes a combination therapy comprising an antagonist of Programmed Death 1 receptor (PD-1), a lenvatinib or a pharmaceutically acceptable salt thereof, and (6S,9aS)-N-benzyl-8-({6-[3-(4-ethylpiperazin-1-yl)azetidin-1-yl]pyridin-2-yl}methyl)-6-(2-fluoro-4-hydroxybenzyl)-4,7-dioxo-2-(prop-2-en-1-yl)hexahydro-2H-pyrazino[2,1-c][1,2,4]triazine-1(6H)-carboxamide (E7386) or a pharmaceutically acceptable salt thereof,—and the use of the combination therapies for the treatment of a cancer.