Novartis

The present invention is directed to a method for the continuous flow preparation of oligonucleotide compounds using solid-phase flow chemistry implemented in two separated process chambers in continuous flow communication, wherein the first process chamber is an activation chamber (upstream chamber) for activating a nucleotide compound, and the second process chamber is a coupling chamber (downstream chamber) for coupling the activated nucleotide compound from the activation chamber to a solid-phase support (SPS)-bound mono-, di-, tri-, oligo- or polynucleotide compound, wherein both process chambers comprise a fluid-permeable divider for separating the activation chamber (a) from the coupling chamber (b) and its solid-phase bound mono-, di-, tri-, oligo- or polynucleotides. The present invention further relates to an alternative method for the continuous flow preparation of oligonucleotide compounds using solid-phase flow chemistry, wherein the 5'-hydroxy of a mono-, di-, tri-, oligo- or polynucleotide bound to a solid phase support (SPS) is activated and reacted with the 3'-hydroxy of a nucleotide to prepare a di-, tri, oligo- or polynucleotide compound in continuous flow preparation.

The present invention relates to compositions of anti-BAFF-R antibodies, such as ianalumab, that can exert potent therapeutic efficacy through BAFF-R binding and antibody-dependent cell-mediated cytotoxicity (ADCC), and method of producing the same and method of treatment using the compositions.

The present invention describes specific crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide. The present invention further relates to methods for preparing said crystalline forms, pharmaceutical compositions comprising said crystalline forms, and methods of using said crystalline forms and pharmaceutical compositions to treat disease.

The present disclosure relates to a pharmaceutical combination comprising (1) a first agent which is a CDK inhibitor or a pharmaceutically acceptable salt thereof and (2) a second agent which is an anti-hormonal agent or a pharmaceutically acceptable salt thereof. The present disclosure also relates to a pharmaceutical combination comprising (1) a first agent which is a CDK inhibitor or a pharmaceutically acceptable salt thereof, (2) a second agent which is an anti-hormonal agent or a pharmaceutically acceptable salt thereof, and (3) a third agent which is an agent that regulates the PI3K/Akt/mTOR pathway or a pharmaceutically acceptable salt thereof.

The invention relates to compounds of the formula (I) <img class="EMIRef" id="387e60f0-aacf-4316-b6d9-42265eac5e26-ia01" /> or a pharmaceutically acceptable salt thereof, wherein the substituents are as defined in the specification; to intermediates in the preparation of the compounds, to pharmaceutical compositions comprising the compounds and to use of the compounds in the treatment of disease.

The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).

Provided herein are compositions and methods for decreasing tau mRNA and protein expression. These compositions and methods are useful in treating tau-related diseases and disorders.

The present disclosure relates to methods for selectively reducing CysL97 in a preparation of IL-17 antibodies or antigen binding fragments thereof (e.g., a preparation of secukinumab antibodies) that have been recombinantly produced by mammalian cells. Also provided are purified preparations of IL-17 antibodies or antigen binding fragments thereof produced by such methods, e.g, purified preparations of secukinumab, wherein the level of intact IL-17 antibodies or antigen binding fragments thereof (e.g., secukinumab) in the preparation is high, e.g., at least about 90%, as measured by sodium dodecyl sulfate capillary electrophoresis (CE-SDS), and wherein the level of activity of IL-17 antibodies or antigen binding fragments thereof (e.g., secukinumab) in the preparation is high, e.g., at least about 92%, as measured by cation exchange chromatograph (CEX).

Anti-BAFFR antibodies are formulated as liquid formulation comprising a high concentration of the antibody active ingredient for delivery to a patient without high levels of antibody aggregation. The aqueous pharmaceutical composition may include one or more sugars, a buffering agent, a surfactant, and/or a free amino acid.

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