The present invention relates to pharmaceutical compositions for inhalation comprising a therapeutically effective dose of clofazimine wherein the clofazimine is provided in the form of dry powder, and processes for their preparation. Furthermore, the present invention provides pharmaceutical combinations comprising clofazimine in the form of an aerosol for pulmonary inhalation. The combinations and compositions provided by the present invention may be used in the treatment and/or prophylaxis of pulmonary infections caused by mycobacteria and other gram-positive bacteria, and of pulmonary fungal infections.

A fixed-dose combination drug product formulated for oral delivery comprises a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin. The fixed-dose combination drug product is sufficiently designed for use in treating pulmonary Mycobacterium avium Complex (MAC) disease in a subject in need thereof. A method for treating MAC disease in a human having MAC lung infection comprising orally administering, twice daily, about 475 mg of clarithromycin, about 40 mg of clofazimine and about 120 mg of rifabutin. A kit for treating pulmonary MAC disease in an individual having MAC lung infection comprises a supply of fixed-dose combination drug products, wherein each of the fixed-dose combination drug products comprise a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin; and instructions for use.

A fixed-dose combination drug product formulated for oral delivery comprises a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin. The fixed-dose combination drug product is sufficiently designed for use in treating pulmonary Mycobacterium avium Complex (MAC) disease in a subject in need thereof. A method for treating MAC disease in a human having MAC lung infection comprising orally administering, twice daily, about 475 mg of clarithromycin, about 40 mg of clofazimine and about 120 mg of rifabutin. A kit for treating pulmonary MAC disease in an individual having MAC lung infection comprises a supply of fixed-dose combination drug products, wherein each of the fixed-dose combination drug products comprise a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin; and instructions for use.

An improved microparticle or lyophilized or otherwise reconstitutable microparticle composition thereof for medical therapy, including ocular therapy.

An improved microparticle or lyophilized or otherwise reconstitutable microparticle composition thereof for medical therapy, including ocular therapy.

The present invention features methods, devices, and kits for detecting gene expression in a patient with a cancer or determining responsive of a patient with a cancer to a treatment, such as treatment with dovitinib or a pharmaceutically acceptable salt thereof. The invention further includes methods of treating a patient with a cancer by administering a treatment, e.g., treatment with dovitinib or a pharmaceutically acceptable salt thereof, in particular when the patient is determined to be responsive to the treatment based on the expression of the biomarkers described herein.

The present invention features methods, devices, and kits for detecting gene expression in a patient with a cancer or determining responsive of a patient with a cancer to a treatment, such as treatment with dovitinib or a pharmaceutically acceptable salt thereof. The invention further includes methods of treating a patient with a cancer by administering a treatment, e.g., treatment with dovitinib or a pharmaceutically acceptable salt thereof, in particular when the patient is determined to be responsive to the treatment based on the expression of the biomarkers described herein.

The present invention provides for compounds that inhibit the activity of an anti-apoptotic Bcl-2 family member Myeloid cell leukemia-1 (Mcl-1) protein. The present invention also provides for pharmaceutical compositions as well as methods for using compounds for treatment of diseases and conditions (e.g., cancer) characterized by the over-expression or dysregulation of Mcl-1 protein.

The present invention provides for compounds that inhibit the activity of an anti-apoptotic Bcl-2 family member Myeloid cell leukemia-1 (Mcl-1) protein. The present invention also provides for pharmaceutical compositions as well as methods for using compounds for treatment of diseases and conditions (e.g., cancer) characterized by the over-expression or dysregulation of Mcl-1 protein.

The present disclosure provides a compound of Formula (IT

##STR00001##

or a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof, wherein R.sub.a, R.sub.b, R.sub.x, R.sub.1, R.sub.2, X.sub.2, and q are as defined herein, and methods of making and using same.