Abstract: The invention relates to a stromal/EMT/TGF? signature that is predictive of patient response to treatment with a PD-1 antagonist, wherein the stromal/EMT/TGF? signature comprises five or more genes selected from Table 1 disclosed herein. More specifically, a lower stromal/EMT/TGF-? score is associated with favorable response to a PD-1 antagonist in a patient with cancer. Also provided are methods of treating a cancer patient with a PD-1 antagonist that were identified as positive for the stromal/EMT/TGF? biomarker of the invention. The disclosure also provides methods and kits for testing tumor samples for the biomarkers.

Abstract: The present invention provides polysaccharide-protein conjugate vaccine formulations comprising a buffer, surfactant, sugar, alkali or alkaline salt, aluminum adjuvant, optionally a bulking agent, and optionally a polymer.

Abstract: The present invention relates to novel Inclusion Complexes of Compound A, compositions comprising an Inclusion Complex of Compound A, and methods of using the Inclusion Complexes of Compound A for preparing compositions useful for treating or preventing HCV infection in a patient, wherein Compound A has the structure:

Abstract: Container system and method for freezing (and subsequently thawing) a liquid such as a drug substance, such that all containers in a set have a uniform width, hence uniform freeze-path length, in the widthwise direction and perpendicular to major walls of the containers, irrespective of the particular length, height, and volumetric capacity of the various containers in the set. This leads to uniform freezing performance and thereby reduces cryoconcentration. The system also eliminates or reduces ice-bridging, and the potential for containers rupturing during freezing and thawing operations.

Abstract: Therapies comprising administering at least one benzo[b]thiophene compound that activates the Stimulator of Interferon Genes (STING) pathway, and the use of such therapies in the treatment of cell-proliferation disorders such as cancer, are disclosed herein.

Abstract: The present invention relates to supplemented serum-containing cell culture media that provides enhances ARPE-19 cell growth and/or improves the yield of human cytomegalovirus (HCMV) grown in ARPE-19 cell cultures. The media of the invention includes two additives, a hormone (e.g., a glucocorticoid hormone such as dexamethasone) and a growth factor (e.g., EGF). The invention further provides methods of producing HCMV in such growth media.

Abstract: The present invention provides a method of producing a polysaccharide-protein conjugate with capsular polysaccharide from Streptococcus pneumoniae serotype 19F conjugated to a carrier protein. The method includes a prolonged incubation step prior to filtration to remove free polysaccharide.

Abstract: The present invention relates to Compounds of Formula I and pharmaceutically acceptable salts or prodrug thereof, wherein R1, R2, R3, R4, X and A are as defined herein. The present invention also relates to compositions comprising at least one compound of Formula I, and methods of using the compounds of Formula I for treating or preventing HIV infection in a subject.

Abstract: The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof and a PH20 variant or fragment thereof. The invention further provides methods for treating various cancers with formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by subcutaneous administration.

Abstract: This disclosure provides pharmaceutical compositions comprising ceftolozane, pharmaceutical compositions comprising ceftolozane and tazobactam, methods of preparing those compositions, and related methods and uses of these compositions.

Abstract: The present invention includes antibodies and antigen-binding fragments thereof that specifically bind to human or cynomolgous monkey LAG3 as well as immunoglobulin chains thereof and polynucleotides encoding the same along with injection devices comprising such antibodies or fragments. Vaccines including such antibodies and fragments as well as compositions comprising the antibodies and fragments (e.g., including anti-PD1 antibodies) are included in the invention. Methods for treating or preventing cancer or infection using such compositions are also provided. In addition, methods for recombinant expression of the antibodies and fragments are part of the present invention.

Abstract: A manually actuated drug-injecting device is configured such that the grip strength of the entire hand (i.e., majority of fingers closing toward the palm or heel of the hand) is employed to discharge medication through a hypodermic needle and into a patient's body. The device is well suited for delivering medications with high viscosity and/or by patients (e.g., elderly patients) with reduced finger strength and dexterity. The device includes a grip member, a push member (which causes the medication to be injected), and a force-transfer mechanism that couples the grip member to the push member. Suitably, the device is configured to be held transverse to the palm of the medication-administering hand, with a discharge port located by the outer, blade edge of the administering hand, when the device is being gripped to administer medication.

Abstract: The present invention discloses oxazolidinone compounds of Formula (I): (I) and pharmaceutically acceptable salts thereof, wherein A and E, are as defined herein. The present invention also relates to compositions which comprise at least one oxazolidinone compound of the invention. The invention also provides methods for inhibiting growth of mycobacterial cells as well as a method of treating mycobacterial infections by Mycobacterium tuberculosis comprising administering a therapeutically effective amount of an oxazolidinone of the invention and/or a pharmaceutically acceptable salt thereof, or a composition comprising such compound and/or salt.

Abstract: Described herein are compounds of Formula (I) or a pharmaceutically acceptable salt thereof. The compounds of Formula (I) act as arginase inhibitors and can be useful in preventing, treating or acting as a remedial agent for arginase-related diseases.

Abstract: An indexing system indexes data entries in a database and processes queries of the database. The indexing system generates a key database storing keys that each represent a vector of a relative attribute between two data entries. For instance, a temporal distance indicates a relative time between timestamps of events represented by the two data entries. In other embodiments, relative attributes may be based on physical proximity, altitude, semantics, etc. The indexing system may also generate a key space database to enable efficient lookup of events associated with a target entity for indexing new data entries. For example, the indexing system may perform one read operation using the key space database to lookup all events associated with the target entity. Furthermore, the indexing system may determine responses for queries to retrieve events that occurred within a target temporal distance before or after a target type of event.

Abstract: The invention provides expression vectors for expressing multi-chain recombinant proteins (e.g., biologics) in mammalian cells. Also provided are host cells comprising the expression vectors, methods of producing the multi-chain recombinant proteins, and methods of propagating the expression vectors.

Abstract: The present invention provides an efficient process for culturing viruses in the presence of an endonuclease and for producing vaccines, typically from live attenuated viruses, under conditions to reduce the presence of host cell DNA and eliminate the need for a post-harvest DNA digestion step.

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: The present disclosure is directed to tetrahydroquinazoline derivatives of Formula I and their use for selectively killing HIV infected GAG-POL expressing cells without concomitant cytotoxicity to HIV naïve cells, and for the treatment or prophylaxis of infection by HIV, or for the treatment, prophylaxis or delay in the onset or progression of AIDS or AIDS Related Complex (ARC).

Abstract: The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant.