Abstract: The present invention provides a compound of formula (I) or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising a compound of the invention, a method for manufacturing compounds of the invention and therapeutic uses thereof.

Abstract: The present invention relates to monoclonal antibodies that specifically bind to chemically-modified nucleic acid molecules, including pan-specific antibodies that bind to chemically-modified nucleic acid molecules independent of nucleotide sequence. The invention also relates to methods of generating monoclonal antibodies to chemically-modified nucleic acid molecules as well as methods of using such antibodies to detect nucleic acid molecules in biological samples. Various immunoassays incorporating the monoclonal antibodies of the invention are also disclosed.

Abstract: Provided herein are solid dispersions comprising AMG 397, methods of preparing the solid dispersion, and pharmaceutical formulations comprising AMG 397.

Abstract: A syringe de-capper including a base having a lower surface and an upper surface opposite the lower surface. The syringe de-capper also includes a de-capping member extending from the upper surface of the base, the de-capping feature including a proximal end adjacent to the base, a distal end spaced away from the base. The de-capping feature includes opposing first and second lateral surfaces defining a proximal thickness at the proximal end and a distal thickness at the distal end, the distal thickness is smaller than the proximal thickness. Also, the syringe de-capper includes a slot disposed in the de-capping member, the slot extending from the distal end of the de-capping member toward the proximal end of the de-capping member and configured to slidably receive a distal end of a syringe for removing a cap therefrom.

Abstract: The present invention provides processes for making 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid as well as intermediates and processes for making the intermediates. Also provided are crystalline forms of the compound and the intermediates.

Abstract: Provided herein are KRAS G12C inhibitors, 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: A robotic inspection platform comprises a robotic arm, an imager, and a controller. The controller causes the robotic arm to retrieve, using its end effector, a container, and to manipulate the container such that the container is sequentially placed in a plurality of orientations while in view of the imager. The controller also causes the imager to capture images, with each of the images being captured while the container is in a respective one of the orientations. The controller also determines one or more attributes of the container, and/or a sample within the container, by analyzing the images using a pattern recognition model and, based on the attribute(s), determines whether the container and/or sample satisfies one or more criteria. If the container and/or sample fails to satisfy the criteria, the controller causes the robotic arm to place the container in an area (e.g., bin) reserved for rejected containers and/or samples.

Abstract: A flexible plunger rod, drug delivery mechanism, drug delivery device, and methods are described that utilize the flexible plunger rod perform drug delivery operations. In embodiments, the flexible plunger rod can be stored in a curved configuration to thereby reduce a footprint of the drug delivery mechanism and device.

Abstract: The present invention provides stabilized activin IIB receptor polypeptides and proteins capable of binding and inhibiting the activities of activin A, myostatin, or GDF-11. The present invention also provides polynucleotides, vectors and host cells capable of producing the stabilized polypeptides and proteins. Compositions and methods for treating muscle-wasting diseases and metabolic disorders are also provided.

Abstract: A drug delivery device includes a housing defining a shell, a container, a drive mechanism, a needle assembly having first and second ends, a fluid flow connection, and a flow adapter, each of which is at least partially disposed within the housing. The container has first and second ends and an inner volume to contain a medicament to be administered to a user. The drive mechanism is adapted to exert a force to urge the medicament out the second end of the container. The fluid flow connection is coupled to the second end of the container and the first end of the needle assembly and is adapted to allow the medicament to flow from the container to the needle assembly. The flow adapter includes at least one protrusion for generating a minor head loss to the medicament flowing within the fluid flow connection and helps to reduce variations of injection rates due to variations in drug product viscosities.

Abstract: An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

Abstract: Described herein is a bispecific molecule containing an Fc polypeptide chain and immunoglobulin variable regions. Also provided are pharmaceutical formulations comprising such molecules, nucleic acids encoding such molecules, host cells containing such nucleic acids, methods of making such molecules, and methods of using such molecules.

Abstract: The present invention provides commercial processes for preparing 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid as well as intermediates thereof.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a housing and a container disposed therein. The container may include a reservoir containing a drug and a movable stopper. A first seal member may be connected to the container at a distal end of the reservoir. A first removable membrane may cover an exterior surface of the first seal member to maintain sterility of that surface prior to operation of the device. A fluid pathway assembly may be configured to establish fluid communication with the reservoir during operation of the device. A second seal member may be connected to a first end of the fluid pathway assembly. A second removable membrane may cover an exterior surface of the second seal member to maintain sterility of that surface prior to operation of the device.

Abstract: Provided herein is a synthesis for omecamtiv mecarbil dihydrochloride hydrate and various intermediates.

Abstract: The present invention relates to RNAi constructs for reducing expression of the HSD17B13 gene. Methods of using such RNAi constructs to treat or prevent liver disease, nonalcoholic fatty liver disease (NAFLD) are also described.

Abstract: A syringe is described with a plunger assembly that is adapted to have a dispensing stroke sized to dispense a fluid therapeutic product from the syringe without dispensing any air or headspace. The syringe includes a plunger rod having a stop feature that stops a dispensing stroke of the plunger rod at a distance corresponding to a level of air or headspace within the syringe avoiding additional air dispensing steps from a healthcare provider.

Abstract: Provided herein are compounds that are useful intermediates that may used to synthesize myeloid cell leukemia 1 protein (Mcl-1) inhibitors. Also provided are 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.