Abstract: Assays to analyze quality and quantity attributes of fixed dose combinations are provided. In particular, assays for fixed dose combinations of two anti-HER2 antibodies, and for subcutaneous formulations comprising pertuzumab and trastuzumab are described herein.

Abstract: The present invention relates to complement component 4 (C4) inhibitors for use in treatment of a neurological disease. The invention in particular relates to the use of C4 inhibitors for down-regulation of C4 expression. The invention also relates to nucleic acid molecules, which are complementary to C4A and/or C4B and capable of reducing the level of an C4A and/or C4B mRNA. Also comprised in the present invention is a pharmaceutical composition and its use in the treatment of a neurological disease.

Abstract: Provided are combination therapies comprising inavolisib (a.k.a. GDC-0077) and other HER2-targeted therapies (e.g., pertuzumab and trastuzumab) for the treatment of HER2-positive cancers; and methods of treating HER2 positive (HER2+) cancers in a patient (preferably a patient with a PIK3CA mutant breast cancer) comprising administering a therapeutically effective amount of inavolisib and a HER2-targeted therapy (e.g., trastuzumab, pertuzumab, or a combination of trastuzumab and pertuzumab).

Abstract: Processes for preparing biheteroaryl compounds are provided, including the biheteroaryl compound 3-(difluoromethoxy)-5-[2-(3,3-difluoropyrrolidin-1-yl)-6-[(1S,4S)-2-oxa-5-azabicyclo[2.2.1]heptan-5-yl]pyrimidin-4-yl]pyridin-2-amine. Among other advantages, the processes provide for: the use of solvents that are relatively non-toxic and inexpensive; reduced usage of expensive precious metal catalysts; reaction temperature reduction in certain steps; the use of relatively non-toxic oxidation agents; the use of inexpensive transition metal catalysts; a reduction of molar ratios of certain reactants thereby improving process efficiency while reducing cost and waste; significantly higher reactant concentrations in certain steps; elimination of the need for multiple chromatographic purification steps; elimination of the need for certain extraction steps using organic solvent; and provide for higher yield and improved purity.

Abstract: A syringe (18) has a longitudinal body (28) with an interior (228) in which a pharmaceutical substance is arranged, a needle connected to one longitudinal end of the body (228) and a rigid needle shield (38) encasing the needle. The rigid needle shield (38) is essentially water vapour tight. The syringe (18) according to the invention allows for preventing needle clogging and, thus, proper provision of pharmaceuticals, particularly by subcutaneous, intramuscular or ocular injection.

Abstract: The present disclosure relates to techniques for continuous integration and continuous deployment of source code on a digital health platform. Particularly, aspects are directed to receiving source code from a software development system (the source code being validated in accordance with a first QMS), generating a profile for the source code, classifying the source code into a class of code based on the profile, retrieving a second QMS associated with the class of code, validating the source code in accordance with the second QMS, upon validation of the source code, executing a build process to generate a executable program from the source code, encapsulating the executable program in a container, and deploying the container on one or more nodes of a software platform. The first QMS is adapted from the perspective of the software development system; whereas the second QMS is adapted from the perspective of the software platform.

Abstract: The invention provides anti-Notch2 antibodies and methods of using the same.

Abstract: The invention provides compositions and methods for treating cancers. The methods comprising administering a PD-1 axis binding antagonist and an anti-GPC3 antibody. The compositions comprising a pharmaceutical composition for treating cancer which comprises a PD-1 axis binding antagonist and an anti-GPC3 antibody. Also disclosed are a pharmaceutical composition to be used in combination with a PD-1 axis binding antagonist for treating cancer which comprises an anti-GPC3 antibody as the active ingredient; and a pharmaceutical composition to be used in combination with an anti-GPC3 antibody for treating cancer which comprises as the active ingredient a PD-1 axis binding antagonist.

Abstract: Disclosed are a phthalazinone compound, and a preparation method therefor and the medical use thereof. In particular, disclosed are a compound as represented by formula (I), and a pharmacodynamically acceptable salt, and the use of the compound as an androgen receptor (AR) for degradation.

Abstract: This present disclosure provides a process for concentrating proteins including an ultrafiltering, a diafiltering, and a second ultrafiltering sequence, at elevated temperatures, such as above about 30° C. The disclosure also includes a process of preparing highly concentrated antibody compositions. and highly concentrated antibody products.

Abstract: The present application relates to systems and methods for assaying presence of large molecule analytes, such as proteins, e.g., antibodies, antigens, receptors, and the like, using a targeted two-dimensional liquid chromatography, tandem mass spectrometry (2D-LC-MS/MS) system, optionally combined with affinity capture. In some aspects, the system is partially or fully automated. In some aspects, the system may allow detection of protein biomarkers (e.g., antibodies or antigens) from clinical or nonclinical biological tissue or fluid samples in the pg/mL to ng/mL range.

Abstract: Described herein are benzoxazepin oxazolidinone compounds with phosphoinositide-3 kinase (PI3K) modulation activity or function having the Formula I structure: or stereoisomers, tautomers, or pharmaceutically acceptable salts thereof, and with the substituents and structural features described herein. Also described are pharmaceutical compositions and medicaments that include the Formula I compounds, as well as methods of using such PI3K modulators, alone and in combination with other therapeutic agents, for treating diseases or conditions that are mediated or dependent upon PI3K dysregulation.

Abstract: The invention provides interleukin-33 (IL-33) antibodies and methods of making and using the same, e.g., for treatment of IL-33 mediated disorders (e.g., ocular disorders such as AMD (e.g., geographic atrophy (GA)).

Abstract: Provided are fused ring compounds of Formula (I), Formula (II), or Formula (III), as further detailed herein, which are used for the inhibition of Ras proteins, as well as compositions comprising these compounds and methods treatment by their administration.

Abstract: The present application relates to anti-PD-L1 antibodies, nucleic acid encoding the same, therapeutic compositions thereof, and their use enhance T-cell function to upregulate cell-mediated immune responses and for the treatment of T cell dysfunctional disorders, including infection (e.g., acute and chronic) and tumor immunity.

Abstract: This disclosure relates to methods of preparing re-usable and dry-able cartridges comprising matrices comprising a detection molecule such as an antibody, for detection or enrichment of an analyte in a sample, such as an antigen recognized by an antibody. In some embodiments, the cartridge comprises a tube or well that holds the matrix. In some embodiments, the matrix or associated cartridges may be stored wet or dry. The disclosure also relates to the cartridges and methods of their use.

Abstract: Disclosed herein are compositions and methods for the treatment of systemic lupus erythematosus using anti-CD20/anti-CD3 bispecific antibodies, such as mosunetuzumab.

Abstract: Anti-K63-linked polyubiquitin monoclonal antibodies, and methods for using the antibodies, are provided.

Abstract: The invention provides an effectorless immunoglobulin Fc protein, fusions of the effectorless Fc protein to a Flt3 ligand, and methods of using the same.

Abstract: Heteroaryl pyridone and aza-pyridone compounds are provided, including stereoisomers, tautomers, and pharmaceutically acceptable salts thereof, useful for inhibiting Btk kinase, and for treating immune disorders such as inflammation mediated by Btk kinase. Methods of using heteroaryl pyridone and aza-pyridone compounds for in vitro, in situ, and in vivo diagnosis, and treatment of such disorders in mammalian cells, or associated pathological conditions, are disclosed.