Abstract: The present invention relates to crystalline avapritinib, polymorphs and hydrates thereof as well as to processes for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising crystalline avapritinib and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of patients with gastrointestinal stromal tumors (GIST) and advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL).

Abstract: Inhaler devices are disclosed (701), and in particular inhaler devices provided with medicament carriers containing individual pockets or blisters of powdered medicament covered by a lidding sheet such as a lidding foil. A common actuator (710) is provided for controlling movement of an indexing system (712,714) for advancing/indexing a dose and an opening system (790,791) for opening a dose such that progression of the opening system (790,791) is disproportional to progression of the indexing system (712,714) during movement of the common actuator (710).

Abstract: The present invention relates to an inhaler device for use with an elongate strip medicament carrier comprising a base with a plurality of medicament pockets or blisters and a peelable lidding sheet covering the blisters, the inhaler device comprising; an indexer movable in a first direction to advance a blister pocket into an inhalation position; an opening system for peeling the peelable lidding sheet from the base to expose medicament within each medicament pocket; the opening system comprising a peel management component movable in a first direction corresponding to said first direction of the indexer to delay the peeling action when the indexer is advanced, and in a second, opposite, direction to allow the lidding sheet to be peeled from the base; wherein the indexer and peel management component are separately driven in said first direction so that movement of the indexer does not dictate movement of the peel management component.

Abstract: The present invention refers to a process for preparing sucrose octasulfate octakistriethylammonium salt (TASOS) powder, comprising the steps of combining a TASOS solution with a polar organic solvent(s) and triethylamine, thereby obtaining a TASOS solution, the polar organic solvent(s), and triethylamine; concentrating said TASOS solution; combining it with 2-methyltetrahydrofuran and/or tetrahydrofuran and triethylamine, thereby obtaining a mixture; and stirring said mixture until a white TASOS powder is obtained. The present invention also refers to a sucrose octasulfate octakistriethylammonium salt (TASOS) powder having a purity of at least 96%, the use of the sucrose octasulfate octakistriethylammonium salt (TASOS) powder for preparing a pharmaceutical composition, and the use of tetrahydrofuran or 2-methyltetrahydrofuran as antisolvent for the preparation of TASOS powder.

Abstract: The present invention relates to solid-state forms of 2-(3-(4-(1H-indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide methane sulfonic acid (INN: belumosudil mesylate) and processes for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising a solid-state form of the present invention and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prophylaxis of autoimmune diseases such as graft-versus-host disease (GvHD) and systemic sclerosis.

Abstract: The present invention relates to a mandelate form of 1-(4-(((6-amino-5-(4-phenoxyphenyl) pyrimidin-4-yl)amino)methyl)piperidin-1-yl)prop-2-en-1-one (INN: evobrutinib) and a process of producing the same. Furthermore, the invention relates to a pharmaceutical composition comprising the mandelate form of evobrutinib and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prevention of multiple sclerosis.

Abstract: The present invention relates to a crystalline form of sotorasib and to a process for its preparation. Furthermore, the invention relates to a pharmaceutical composition comprising the crystalline form of sotorasib of the present invention and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of a cancer with a KRAS mutation.

Abstract: The present invention relates to co-crystals comprising levothyroxine and a dicarboxylic acid, preferably L-tartaric acid or oxalic acid, and processes for the preparation thereof. Furthermore, the invention relates to a pharmaceutical composition comprising a co-crystal of the present invention, preferably the co-crystal comprising levothyroxine and L-tartaric acid or oxalic acid, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of hypothyroidism.

Abstract: The present invention relates to crystalline compounds comprising vadadustat and L-proline and processes for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising one or more of the crystalline compounds of the present invention and at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment and/or prevention of anemia for example in patients with end-stage renal disease (ESRD) and/or chronic kidney disease (CKD).

Abstract: The present invention is directed to a parenteral pharmaceutical composition comprising cyclophosphamide and a mixture of specific liquids in specific amounts, respectively.

Abstract: The invention relates to acid addition salts of ridinilazole and processes for the preparation of ridinilazole using these acid addition salts. In addition, the present invention relates to processes for the preparation of ridinilazole in pure form using acid addition salts of ridinilazole as process intermediates.

Abstract: The present invention is in the field of recombinant biotechnology, in particular in the field of protein expression. The invention generally relates to a method of expressing a protein of interest (POI) from a host cell. The invention relates particularly to improving a host cell's capacity to express and/or secrete a protein of interest and use of the host cell for protein expression. The invention also relates to cell culture technology, and more specifically to culturing cells to produce desired molecules for medical purposes or food products.

Abstract: The present invention is related to a pharmaceutically acceptable aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein, wherein the concentration ratio between the biopharmaceutical protein and the neutral salt is in the range of ?0.7 and ?5.