A probiotic composition and method for activating probiotic spores for consumption by a human to reduce inflammation in or treat inflammatory conditions in the gut. A probiotic composition comprises a nutrient-germinant composition, one or more species of Bacillus spores, and optionally a food or beverage product, which are mixed or pre-mixed in any combination. A nutrient-germinant composition comprises one or more L-amino acids, optionally a source of potassium ions, and optionally one or more buffers, if the source of potassium ions is not also a buffer. A method of activating the spores comprises heating the probiotic composition or food or beverage containing the probiotic composition to a temperature range of around 42° C.-100° C., more preferably 70° C.-85° C. prior to being administered to ingested. Dosing the probiotic composition at around 1 to 4 grams per day over a treatment cycle can reduce indicators of inflammation by at least 10-20% or more.

The present invention is directed to methods for filling a container wherein the filled container has no headspace. The present invention is further directed to methods for stabilizing an aqueous drug substance solution by filling a container with the aqueous drug substance solution wherein the filled container has no headspace. The present invention is further directed to methods for detecting headspace in a container.

Ligand-bound gold clusters and compositions comprising the ligand-bound gold clusters are used for treating liver cirrhosis and manufacturing a medicament for treatment of liver cirrhosis. Methods for treating liver cirrhosis.

The present invention relates to a pharmaceutical composition, particularly a pharmaceutical composition comprising an IgG:TGFβRII (such as an anti-PD-L1:TGFβ-inhibiting) fusion protein. The present invention also relates inter alia to a method of manufacturing the composition, to a kit including the composition, to a package including the composition, to a method of manufacturing the package, and to methods of treatment using the composition and/or package, especially cancer treatments.

Provided is a liquid preparation containing an anti-IL-17 antibody at a concentration of 20 mg/mL to 200 mg/mL, a citrate buffer at a concentration of 10 mM to 50 mM, a sucrose at a concentration of 20 mg/mL to 120 mg/mL or arginine at a concentration of 50 mM to 250 mM, and polysorbate 80 at a concentration of 0.1 mg/mL to 5 mg/mL. In addition, the liquid preparation has a pH of 6.0±0.5, wherein the anti-IL-17 antibody is an anti-IL-17A/F monoclonal antibody. The liquid preparation can be a stable subcutaneous injection preparation, and can be used to treat IL-17A and/or IL-17F related diseases, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease.

The present disclosure is directed to formulations and methods for treating or preventing head pain, including migraines, with dihydroergotamine mesylate.

This invention provides novel compositions comprising an anti-inflammatory agent and a mydriatic agent suitable for intraocular use, particularly ketorolac or pharmaceutically salts thereof and phenylephrine or pharmaceutically salts thereof, which are free of any buffering agent and yet, surprisingly, maintain stability for significant periods of time (e.g., at least about 3 months). The present invention also relates to a process of preparing such compositions and use thereof, e.g., in combination with intraocular ophthalmologic irrigation solutions.

The present invention relates to pharmaceutical formulations comprising the C1 esterase inhibitor (C1-INH), exhibiting a higher stability for prolonged storage and a reduced formation of aggregates of said esterase inhibitor (C1-INH) upon storage for ameliorated use in treating or preventing disorders related to kinin formation.

An object of the present invention is to provide a lyophilized formulation having improved storage stability of hepatic growth factor compared to conventional lyophilized formulations. The present invention provides a lyophilized formulation comprising (1) a hepatic growth factor, (2) trehalose and (3) one or more compounds selected from the group consisting of arginine, histidine, lysine, meglumine, glutamic acid, aspartic acid, proline, creatine, creatinine, tris(hydroxymethyl)aminomethane, and pharmaceutically acceptable salts thereof.

Provided are various aqueous formulations of the neonatal Fc receptor (FcRn) antagonist ARGX-113, including formulations useful as pharmaceutical compositions, methods for their preparation, devices comprising the various formulations, and uses thereof. In certain embodiments the formulations are suitable and useful for administration of ARGX-113 to a human subject. In certain embodiments the formulations are suitable and useful for subcutaneous administration of ARGX-113 to a human subject. The formulations can be used in the treatment of any condition that would benefit from inhibition of FcRn-mediated antibody recycling. Such conditions can include any one or more of various antibody-mediated autoimmune diseases, including, for example and without limitation, myasthenia gravis (MG) and immune thrombocytopenia (ITP).