Abstract: This disclosure relates to stable aqueous pharmaceutical formulations comprising a therapeutically effective amount of an incretin-insulin conjugate as well as methods of using the same, and aqueous pharmaceutical formulations containing an incretin-insulin conjugate which are stable and which provide a protracted pharmacodynamics profile, which include L-arginine HCl and phenol (or m-cresol) as stabilizing agents. The invention also provide a method of treating a patient or individual having a metabolic disease, comprising administering to the patient or individual an effective amount of any of the aqueous pharmaceutical formulations described herein.

Abstract: Disclosed herein are substituted pyrazole-pyrimidine compounds of Formula I and variants thereof for the treatment, for example, of diseases associated with P2X purinergic receptors: In one embodiment, the P2X3 and/or P2X2/3 antagonists disclosed herein are potentially useful, for example, for the treatment of visceral organ, cardiovascular and pain-related diseases, conditions and disorders.

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: A handheld, battery operated device that, when activated, will grip a screw-cap on the top of a cryogenic vial, microtube, test tube or other pharmaceutical product container, and automatically rotate the cap in a counterclockwise direction to remove the cap, and automatically rotate the cap in a clockwise direction to fasten the cap back on the cryogenic vial, microtube, test tube or other pharmaceutical product container.

Abstract: The present invention relates to novel Bicyclic Heterocycle Compounds of Formula (I) and pharmaceutically acceptable salts thereof, wherein A, X, Y, Z, R1 R5, R6, and R7 are as defined herein. The present invention also relates to compositions comprising at least one Bicyclic Heterocycle Compound, and methods of using the Bicyclic Heterocycle Compounds for treating or preventing a herpesvirus infection in a patient.

Abstract: Provided herein are methods of treating cancer (e.g., RCC), which comprise administering to a human patient in need thereof: (a) a PD-1 antagonist; (b) an ILT4 antagonist; and (c) lenvatinib represented by Formula (I), or a pharmaceutically acceptable salt thereof. Also provided are kits containing such agents and uses of therapeutic combinations of such agents for the treatment of cancer.

Abstract: Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.

Abstract: A reusable safety syringe training device is provided. The device comprises a syringe contained within a syringe protective member. The syringe protective member is movable vertically within an outer protective sheath from a first position to a second position and back to the first position. In the first position, the device is in an injection-ready position with the needle exposed and the syringe protective member in a locked vertical position with respect to the outer protective sheath. In the second position, the device is in a post-injection position such that the syringe protective member is no longer vertically locked with respect to the outer protective sheath and has moved vertically upward thereby rendering the needle within the outer protective sheath. The plunger carries a release flange sufficient to engage release latches that otherwise retain the syringe protective member in the first position.

Abstract: Disclosed herein is a novel process for preparing Compound A free base, 5-((2,4-diaminopyrimidin-5-yl)oxy)-4-iso-propyl-2-methoxybenzenesulfonamide, and a citrate salt of Compound A with simplified chemistry and a high overall yield: Compound A. In one embodiment, the overall yield from the starting material 2-isopropylphenol to Compound A citrate salt is greater than 50%. In another embodiment, the overall yield is greater than 60%. Also disclosed herein are novel salts and solvates of Compound A.

Abstract: The present disclosure provides, among other things, a single-dose vaccine composition that includes a chitosan adjuvant and HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82, where the single-dose vaccine composition provides enhanced or comparable HPV vaccine response in comparison to a similar multiple-dose vaccine formulated without such chitosan adjuvant.

Abstract: Provided herein are methods of treating cancer (e.g., NSCLC), which comprise administering to a human patient in need thereof: (a) a PD-1 antagonist; (b) an ILT4 antagonist; and (c) one or more chemotherapeutic agents. Also provided are pharmaceutical compositions and kits containing such agents for the treatment of cancer.

Abstract: The present invention provides capsular polysaccharides from Streptococcus pneumoniae serotypes identified using NMR. The present invention further provides polysaccharide-protein conjugates in which capsular polysaccharides from one or more of these serotypes are conjugated to a carrier protein such as CRM197. Polysaccharide-protein conjugates from one or more of these serotypes may be included in multivalent pneumococcal conjugate vaccines having polysaccharides from multiple additional Streptococcus pneumoniae serotypes.

Abstract: The present invention relates to monoclonal antibodies which have high anti-RSV neutralizing titers. The invention further provides for isolated nucleic acids encoding the antibodies of the invention and host cells transformed therewith. The invention yet further provides for diagnostic, prophylactic and therapeutic methods employing the antibodies and nucleic acids of the invention, particularly as a passive immunotherapy agent in infants and the elderly.

Abstract: Long-acting co-agonists of the glucagon and GLP-1 receptors are described.

Abstract: The disclosure relates to stable RSV F proteins and immunogenic compositions containing the same, as well as methods of using the immunogenic compositions and compositions comprising the RSV F proteins.

Abstract: A visualization system generates for display one or more radial maps that represent data values for a plurality of parameters measured for groups of entities. Each group of rows of the radial map represents a group of entities for whom the parameters are measured and compared against a baseline or control group, while each column represents a measured parameter. If the visualization system determines that an entity has a data value for a measured parameter that deviates from the control group value by more than a threshold amount, the system visually distinguishes the outlier value from the other geometric shapes in the radial map. Additionally, two or more radial maps may be simultaneously displayed on a visual interface based on correlations between data points for groups of entities.

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: A stopper retainer comprises a base having an upper surface, a lower surface, and a perimeter; a sidewall joined to the base around the perimeter, the sidewall having a raised height to define an interior cavity with the base; and a plurality of projections extending from the lower surface of the base, each of the plurality of projections being sized to at least partially fit within a lumen of a syringe barrel.

Abstract: The present invention provides capsular polysaccharides from Streptococcus pneumoniae serotypes identified using NMR. The present invention further provides polysaccharide-protein conjugates in which capsular polysaccharides from one or more of these serotypes are conjugated to a carrier protein such as CRM197. Polysaccharide-protein conjugates from one or more of these serotypes may be included in multivalent pneumococcal conjugate vaccines having polysaccharides from multiple additional Streptococcus pneumoniae serotypes.

Abstract: The present invention relates to a method of measuring at least one product quality attributes, including critical quality attributes (e.g., oxidation, C-terminal lysine, aggregation, N-terminal glutamine cyclization.) by an online liquid chromatography system, wherein the liquid chromatography system is running a hydrophobic interaction chromatography (HIC) method.