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.

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: The invention relates to a parenteral pharmaceutical composition comprising azacitidine and dimethyl sulfoxide.

Abstract: A pharmaceutical formulation is disclosed which includes at least: (1) elagolix sodium, (2) magnesium oxide, and (3) at least one disintegrating agent, such as crospovidone, croscarmellose sodium, sodium starch glycolate, pregelatinized and mixtures thereof. A tablet is also disclosed which includes a tablet core formed from the pharmaceutical formulation. The elagolix sodium tablets of the present disclosure display improved dissolution rates when tested using for example the Tablet Sink Time test. The tablets also exhibit improved storage stability of the elagolix sodium, with a reduction in degradation products during storage.

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 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 forms of cabotegravir sodium and to methods for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising one of said crystalline forms of cabotegravir sodium, preferably in a predetermined and/or effective amount, and at last 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 viral infections such as HIV infections.

Abstract: The present invention relates to a process for preparing a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an active pharmaceutically ingredient (API). The tablet comprises a granulate comprising said at least freely soluble solid form of an active pharmaceutically ingredient in form of granules, and a tablet base, with the granules exhibiting a certain minimum size, and the tablet base comprising a disintegrant. The process comprises a step of mixing the API-containing granulate with the tablet base, followed by a step of compressing the mixture to form the tablet. The present invention also relates to a rapidly or very rapidly dissolving tablet comprising an at least freely soluble solid form of an API, wherein said tablet comprises a mixture of API-containing granulate comprising API-containing granules, and a disintegrant-containing tablet base, with the granules exhibiting a certain minimum size.

Abstract: The present invention relates to avibactam free acid, a method for preparing avibactam free acid and a method for preparing avibactam sodium by further reacting avibactam free acid. The invention further refers to a pharmaceutical composition comprising avibactam free acid, one or more alkaline sodium salt(s) and one or more beta-lactam antibiotic(s). The pharmaceutical composition of the present invention can be used as medicament, in particular for treatment and/or prevention of bacterial infections.

Abstract: The invention relates to crystalline eravacycline Ns-hydrochloride and to a process for its preparation. Furthermore, the invention relates to the use of crystalline eravacycline bis-hydrochloride for the preparation of pharmaceutical compositions. The invention further relates to pharmaceutical compositions comprising an effective amount of crystalline eravacycline bis-hydrochloride. The pharmaceutical compositions of the present invention can be used as medicaments, in particular for treatment and/or prevention of bacterial infections e.g. caused by Gram negative pathogens or Gram positive pathogens, in particular caused by multidrug resistant Gram negative pathogens. The pharmaceutical compositions of the present invention can thus be used as medicaments for e.g.

Abstract: The present invention relates to a co-crystal of baricitinib with lactic acid and to a process for its preparation. Furthermore, the invention relates to a pharmaceutical composition comprising said baricitinib lactic acid co-crystal, at least one pharmaceutically acceptable excipient. The pharmaceutical composition of the present invention can be used as a medicament, in particular 5 for the treatment and/or prevention of rheumatoid arthritis, atopic dermatitis, systemic lupus erythematosus (SLE), psoriatic arthritis and psoriasis.

Abstract: The present invention relates to an oral dosage form containing rifaximin in form beta, wherein the oral dosage form provides delayed release of the active pharmaceutical agent. Further, the invention relates to the preparation of an oral dosage form, preferably a tablet.

Abstract: The present invention relates to crystalline forms of cabotegravir sodium and to methods for their preparation. Furthermore, the invention relates to a pharmaceutical composition comprising one of said crystalline forms of cabotegravir sodium, preferably in a predetermined and/or effective amount, 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 viral infections such as HIV infections.

Abstract: The invention relates to crystalline eravacycline bis-hydrochloride and to a process for its preparation. Furthermore, the invention relates to the use of crystalline eravacycline bis-hydrochloride for the preparation of pharmaceutical compositions. The invention further relates to pharmaceutical compositions comprising an effective amount of crystalline eravacycline bis-hydrochloride. The pharmaceutical compositions of the present invention can be used as medicaments, in particular for treatment and/or prevention of bacterial infections e.g. caused by Gram negative pathogens or Gram positive pathogens, in particular caused by multidrug resistant Gram negative pathogens. The pharmaceutical compositions of the present invention can thus be used as medicaments for e.g. the treatment of complicated intra-abdominal and urinary tract infection.

Abstract: The invention relates to an amorphous solid dispersion comprising elagolix sodium and at least one silicon-based inorganic compound and to a process for preparing the same. Furthermore, it relates to a pharmaceutical composition comprising said solid dispersion and one or more additional pharmaceutical acceptable excipient(s), wherein the pharmaceutical composition can be used as a medicament, in particular for the treatment of endometriosis and uterine fibroids.

Abstract: The present invention relates to a crystalline form of darolutamide and to a process for its preparation. Furthermore, the invention relates to a pharmaceutical composition comprising said crystalline form of darolutamide, preferably in a predetermined and/or effective amount, and at least one pharmaceutically acceptable excipient. The present invention also relates to 5 pharmaceutical compositions comprising darolutamide at a high drug load. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of prostate cancer.