Janssen Pharmaceuticals, Inc.

Various exemplary methods, systems, and devices for vial holders are provided. The vial holders are assembled from housing components with a two-step snap closure, where a first step partially assembles the vial holders into a stable first configuration to form vial slots and shelf platforms for ease of receiving vials. The vial holders are advantageous for holding and labeling vials containing temperature sensitive therapeutic formulations that need to be handled under conditions limited by time and dexterity by permitting partial pre-assembly and labeling at a remote location and facilitating final assembly with minimal effort. In some embodiments, the vial holders incorporate tamper resistant structures that physically shield the two-step snap closure from external access.

Modified oligonucleotides comprising a GalNAc moiety of the present disclosure along with methods of making and use, e.g., against HBV are disclosed.

The invention provides analytical methods for identifying and quantifying complex glycoconjugate compositions, in particular for the analysis of a glycoconjugate in a sample comprising at least 4 glycoconjugates.

The present disclosure generally relates to viral-based expression systems suitable for the production of molecule of interests in recombinant host cells. The disclosure particularly relates to nucleic acid constructs, such as expression vectors, containing a modified arterivirus genome or replicon RNA in which at least some of its original viral sequence has been deleted. Also included in the disclosure are viral-based expression vectors including one or more expression cassettes encoding heterologous polypeptides. In some embodiments, the expression cassettes are configured and positioned at defined locations on the viral genome so as to enable expression of the heterologous polypeptides in a tunable manner.

The present invention provides methods of maintaining stable remission or stable response achieved by a patient with depression following administration of a therapeutically effective amount of esketamine during an initial administration phase, comprising continuing administration of a therapeutically effective amount of esketamine for at least five months during a subsequent administration phase. The present invention also provides methods for the long term treatment of depression in a patient, comprising administering to the patient in need of the treatment a clinically proven safe and clinically proven effective therapeutically effective amount of esketamine for at least six months. In some embodiments, the depression is major depressive disorder or treatment resistant depression.

Liposomes containing tau peptides, preferably phosphorylated tau peptides, and conjugates containing tau peptides, preferably phosphorylated tau peptides, conjugated to an immunogenic carrier are described. Pharmaceutical compositions and uses of the liposomes and/or conjugates for treating or preventing a neurodegenerative disease or disorder, such as Alzheimer's Disease, are also described.

The disclosure provides compositions containing pure aticaprant, solvates of aticaprant, and methods of treating major depressive disorder using aticaprant.

The disclosure provides crystalline and amorphous forms of aticaprant. Also provided by the disclosure are pharmaceutical compositions comprising the amorphous or crystalline forms, methods of treating major depressive disorder using the amorphous or crystalline forms of aticaprant, amorphous or crystalline forms of aticaprant for use in the treatment of major depressive disorder in a human patient having anhedonia, uses of the amorphous or crystalline forms of aticaprant in the manufacture of a medicament for the treatment of major depressive disorder, and packages or pharmaceutical products comprising (i) amorphous or crystalline forms of aticaprant and (ii) instructions for treating major depressive disorder. In some aspects, the human patient treated as described herein has anhedonia.

In general, interconnection of drug administration systems is provided. In an exemplary embodiment, a drug administration device and a remotely located server can establish a unique key for wireless communication between the device and the server. The drug administration device can be configured to sense information relating to at least one of the device and a drug and can be configured to anonymize data indicative of the sensed information using the key stored in memory of the device. The drug administration device can also be configured to use the key in decrypting data received from the server.

Polypeptides comprising a FimH lectin domain comprising an amino acid mutation that causes the FimH lectin domain to be in the low affinity conformation for mannose are described. Pharmaceutical compositions which comprise such polypeptides and methods of stimulating an immune response in a subject in need thereof by administration of the polypeptide are further described.