Fulvestrant formulations suitable for intramuscular injection at concentration in excess of 40 mg/ml in the absence of castor oil and castor oil derivatives are disclosed.

The subject matter described herein is directed to methods of preparing certain antibody-drug conjugates (ADCs) wherein the antibody is linked to the drug through a linker, wherein the drug contains a heteroaryl group having a secondary nitrogen, and the linker is attached to the drug via the secondary nitrogen. The resulting conjugates are useful in treating various diseases and conditions.

Disclosed is a new indole compound, in particular, the compound as shown in formula (I), and a preparation method, pharmaceutical composition and use thereof as an estrogen receptor down-regulator in preparing drugs for treating estrogen receptor-positive breast cancer.

##STR00001##

Pharmaceutical compositions and methods for the treatment of DENND1A.V2 related disorders, such as PCOS, are provided. In particular, humanized and mouse monoclonal antibodies specific for DENND1A.V2 and methods for using the same are provided.

Described herein are compounds that are estrogen receptor modulators. Also described are pharmaceutical compositions and medicaments that include the compounds described herein, as well as methods of using such estrogen receptor modulators, alone and in combination with other compounds, for treating diseases or conditions that are mediated or dependent upon estrogen receptors.

Provided is a pharmaceutical composition which contains fulvestrant in an amount of 4.5% by mass to 10.0% by mass with respect to the entire mass of the pharmaceutical composition, at least one kind of polyhydric alcohol selected from propylene glycol or 1,3-butylene glycol in an amount of 8% by mass to 23% by mass with respect to the entire mass of the pharmaceutical composition, benzyl alcohol in an amount of 5% by mass to 24% by mass with respect to the entire mass of the pharmaceutical composition, benzyl benzoate in an amount of 8% by mass to 19% by mass with respect to the entire mass of the pharmaceutical composition, and castor oil, and in which a content of ethanol is less than 1% by mass with respect to the entire mass of the pharmaceutical composition, and a content of benzoic acid is less than 1% by mass with respect to the entire mass of the pharmaceutical composition.

Novel compounds of Formula I ##STR00001##
and their use in therapeutic treatments.

The present invention provides a solid preparation wherein variation in weight is suppressed, a solid preparation wherein the active ingredient is stabilized, and a stabilization method thereof. A solid preparation containing (1) an active ingredient, (2) D-mannitol and (3) an alkaline earth metal salt selected from magnesium aluminometasilicate and calcium silicate. A method of stabilizing the active ingredient, including adding an alkaline earth metal salt selected from magnesium aluminometasilicate and calcium silicate.

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.

An equol-producing lactic acid bacteria-containing composition comprises, as an essential component thereof, a lactic acid bacterial strain belonging to the genus Lactococcus having an ability to utilize at least one daidzein compound selected from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein to produce equol. Such a composition is effective for the prevention and alleviation of malaise inclusive of climacteric disturbance in middle-aged and elderly women for which no effective prophylactic method or alleviating means has heretofore been available.