Janssen Pharmaceutica

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.

The present invention provides methods to promote the differentiation of pluripotent stem cells. In particular, the present invention provides methods to produce a population of cells, wherein greater than 10% of the cells in the population express markers characteristic of single hormonal pancreatic beta cells.

The present disclosure is directed to a method of operating a chromatography column in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNFα antibody SIMPONI^® (golimumab), and specific pharmaceutical compositions of the antibody. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is determined based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. The height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value. If during routine column monitoring, an adverse trend in HETP is observed or the control limits are exceeded, the eluate product quality, column process performance, and/or impurity removal data should be evaluated to ensure product quality for the identified batch. Should any of the product quality or column performance fail the criteria set, appropriate corrective action, such as conditioning, repacking or replacing the column, and qualification should be performed prior to release for further use.

Disclosed are methods of treating a subject having high-risk multiple myeloma, methods of achieving negative minimal residual disease status in a subject having multiple myeloma, and methods of predicting a likelihood of, or decreasing a risk of, relapse and/or disease progression in a subject having multiple myeloma.

Various exemplary drug delivery devices with reusable components and disposable components, drug products utilizing the same, and methods of using drug delivery devices with reusable components and disposable components are provided. In general, a nasal drug delivery device is configured to deliver a drug therefrom and includes one or more disposable components and one or more reusable components. The one or more disposable components are releasably coupled to the one or more reusable components. After the drug is delivered from the drug delivery device, the one or more disposable components can be detached from the one or more reusable components. Another one or more disposable components can then be releasably coupled to the one or more reusable components and the drug delivery device used to again deliver a drug therefrom.

Disclosed are methods of treating cancers and enhancing efficacy of T cell redirecting therapeutics.

Drug delivery devices having a drug-permeable component and methods of making and using the same are provided. Drug delivery devices include a housing having a first and second wall structures that are adjacent one another and together form a tube defining a drug reservoir lumen. The second wall structure, or both the first wall structure and the second wall structure, are permeable to water, and the first wall structure is impermeable to the drug while the second wall structure is permeable to the drug, such that the drug is releasable in vivo by diffusion through the second wall structure.

A method of treating Crohn's disease in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial intravenous dose and subsequence subcutaneous doses.

A method of treating psoriasis in a patient by administering an IL-23 specific antibody, e.g., guselkumab, in a safe and effective amount and the patient achieves PASI90, PASI100 or IGA 0 or 1 score as measured 16, 24, 32, 40 and 48 weeks after initial treatment.

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