Abstract: Pharmaceuticals compositions comprising the 2S, 4R, ketoconazole enantiomer or its pharmaceutically acceptable salts, hydrates, and solvates, that are substantially free of the 2R, 4S ketoconazole enantiomer are useful to reduce cortisol synthese and for the treatment of type 2 diabetes, hyperglycemia, obesity, insulin resistance, dyslipidemia, hyperlipidemia, hypertension, Metabolic Syndrome, and other diseases and conditions, including but not limited to Cushing's Syndrome, depression, and glaucoma.

Abstract: The present invention relates to therapeutic combinations comprising WNT inhibitors and methods for treating cancers using combination therapy.

Abstract: The present invention provides a preservative free ophthalmic formulation. In particular, the ophthalmic formulations of the invention are aqueous formulations comprising nanoemulsion of oil. The present invention also provides a method for treating an eye disorder. In one particular embodiment, the invention provides methods for treating dry eye syndrome using an preservative free formulation comprising a nanoemulsion of oil and alpha 2 adrenergic agonist, pharmaceutically acceptable salt thereof or a mixture thereof. In particular, the alpha 2 adrenergic agonist of the invention has a higher alpha 2A agonist activity compared to alpha 2B agonist activity. This invention also provides a preservative free ophthalmic composition comprising a nanoemulsion of oil, a therapeutically effective amount of an alpha 2 adrenergic agonist, a pharmaceutically acceptable salt thereof or a combination thereof as an active ingredient for treating a dry eye syndrome.

Abstract: Disclosed is a use of trimethazine in the preparation of drugs for preventing and treating liver diseases. Trimethazine is capable of inhibiting activation of resting T-cells to activated lymphocytes, reducing release of cytokines, and reducing hepatocyte injury caused by immune system; inhibiting fatty acid metabolism in hepatocytes, and optimizing the energy process in hepatocytes; and maintaining normal function of mitochondrial permeability transition pores, and reducing hepatocyte apoptosis. Trimethazine has the efficacy of maintaining the liver functions, and reducing transminase (comprising glutamic pyruvic transaminase, glutamic oxalacetic transaminase, etc.).

Abstract: Compounds for use in the treatment of human immunodeficiency virus (HIV) infection are disclosed. The compounds have the following Formula (I): including stereoisomers and pharmaceutically acceptable salts thereof, wherein R1, X, Y1, Y2, or L are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

Abstract: An Axl inhibitor and one or more immune checkpoint (activity) modulators and/or one or more oncolytic viruses, for use in the prevention, treatment or management of cancer, wherein the Axl inhibitor and the one or more immune checkpoint (activity) modulators and/or the one or more oncolytic viruses are administered concurrently, separately or sequentially; compositions containing such components in combination; and methods of treating cancer in a patient by administering such components in combination.

Abstract: Phthalazinediones that function as intracellular redox modulators in the redox therapy of certain stressed cells are provided. By buffering aberrant redox states, phthalazinediones enable cellular processes essential for survival and augment medical treatments. The phthalazinediones of the invention can modulate functions related to cell growth, differentiation, activity, or death, to correct aberrations and restore homeostasis, and can serve as adjunctive therapy in treating various disease conditions.

Abstract: The present disclosure provides pharmaceutical compositions comprising micronized Compound A and use thereof.

Abstract: The present invention describes novel pharmaceutical compositions and methods for treatment of diseases, disorders, or conditions characterized by recurrent seizures, particularly, epilepsy. According to the invention, compounds which inhibit the activity or expression of non-receptor Fyn tyrosine kinase can prevent activation epileptic pathophysiology and provide protection from and treatment of epilepsy. Particularly preferred is the class of small molecule Fyn kinase inhibitors such as sacaratinib and its prodrugs, derivatives, analogs and the like.

Abstract: The present disclosure describes a pharmaceutical combination of an anti-CD19 antibody and a Bruton's tyrosine kinase (BTK) inhibitor for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and/or acute lymphoblastic leukemia.

Abstract: A method comprising: (a) identifying a subject in need of treatment for cataract and/or nevus and/or tumor lesion; and (b) topically administering to the eye an amount of dipyridamole which is physiologically effective in treatment of cataract and/or nevus and/or melanoma.

Abstract: The present invention provides novel compounds of Formula (I), and pharmaceutically acceptable salts, solvates, hydrates, polymorphs, co-crystals, tautomers, stereoisomers, isotopically labeled derivatives, prodrugs, and compositions thereof. Also provided are methods and kits involving the inventive compounds or compositions for treating or preventing proliferative diseases (e.g., cancers (e.g., lung cancer, breast cancer, leukemia, lymphoma, melanoma, multiple myeloma, Ewing's sarcoma, osteosarcoma, brain cancer, neuroblastoma), benign neoplasms, angiogenesis, inflammatory diseases, autoinflammatory diseases, and autoimmune diseases) in a subject. Treatment of a subject with a proliferative disease using a compound or composition of the invention may inhibit the aberrant activity of a kinase (e.g. a protein kinase (e.g. a cyclin-dependent kinase (CDK) (e.g. CDK7, CDK12, or CDK13) or a lipid kinase such as a phosphatidylinositol-5-phosphate 4-kinase (PIP4K) (e.g.

Abstract: The present invention provides crystalline forms of Ibrutinib. Specific crystalline forms provided by the present invention include Ibrutinib Form APO-I, an anhydrous form; APO-II, a methyl benzoate solvate of Ibrutinib; and APO-IV, a methyl salicylate solvate of Ibrutinib.

Abstract: Disclosed are methods of treating fibrosis in a patient, comprising administering to a patient in need thereof a therapeutically effective amount of an ACK inhibitor (e.g., a BTK inhibitor, such as for example an irreversible BTK inhibitor, such as for example, ibrutinib).

Abstract: The present invention relates to a combination therapy comprising the use of riboflavin and oxaloacetate. Specifically, it is directed to new compositions, pharmaceutical compositions, kits of parts and methods for treating ischemic stroke and/or other excitotoxicity-associated diseases. It further relates to riboflavin for use in the therapeutic treatment of acute ischemic stroke by intravascular administration within the first twelve hours of symptom onset.

Abstract: Several compounds have been discovered that modulate signal transduction through the PD-1 receptor. In certain embodiments, the compounds promote or induce an activating signal through the PD-1 receptor that activates a T cell. The compounds can bind to PD-1 and inhibit or prevent ligands from binding to PD-1 and thereby suppress inhibitory signal transduction through the PD-1 receptor.

Abstract: Pharmaceutical compositions comprising the drug substance (R,E)-N-(7-chloro-1-(1-(4-(dimethylamino)but-2-enoyl)azepan-3-yl)-1H-benzo[d]imidazol-2-yl)-2-methylisonicotinamide and processes to prepare these compositions.

Abstract: This invention relates to compounds that are agonists of the muscarinic M1 receptor and which are useful in the treatment of muscarinic M1 receptor mediated diseases. Also provided are pharmaceutical compositions containing the compounds and the therapeutic uses of the compounds. Compounds provided are of formula I, where n is 1 or 2; p is 0, 1 or 2; q is 0, 1 or 2; and R1-R6 are as defined herein.

Abstract: The present invention relates to the seminal discovery of methods of using recombinant galectin proteins to reverse HIV latency. Specifically, the present invention relates to the use of recombinant galectin-9 (rGal-9) to reactivate latent HIV, wherein the HIV is hypermutated rendering the virus replication incompetent. Further, rGal-9 induces the expression of APOBEC3 cytidine deaminases and NFkB pathway components and decreases histone deacetylase (HDAC) expression.

Abstract: The invention provides methods for inducing, enhancing or increasing satellite cell proliferation, and an assay for screening for a candidate compound for inducing, enhancing or increasing satellite cell proliferation. Also provided are methods for repairing or regenerating a damaged muscle tissue of a subject.

Abstract: Biocompatible microparticles include an ophthalmically active cyclic lipid component and a biodegradable polymer that is effective, when placed into the subconjunctival space, in facilitating release of the cyclic lipid component into the anterior and posterior segments of an eye for an extended period of time. The cyclic lipid component can be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the cyclic lipid component can be encapsulated by the polymeric component. The present microparticles include oil-in-water emulsified microparticles. The subconjunctivally administered microparticles can be used to treat or to reduce at least one symptom of an ocular condition, such as glaucoma or age related macular degeneration.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.

Abstract: The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.

Abstract: Provided are compositions comprising a benzodiazepine and a neurosteroid, containing one or both of the benzodiazepine and the neurosteroid in a subtherapeutic dose, and administration of such compositions for mitigation of an epileptic seizure. Further provided are compositions comprising a benzodiazepine, a neurosteroid, and an NMDA blocker, and administration of such compositions for mitigation of an epileptic seizure.

Abstract: Methods of treating airway diseases in equines include administering to an equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition including ciclesonide or a pharmaceutically acceptable salt thereof.

Abstract: The invention disclosed herein provides a method for treating Community-Acquired Bacterial Pneumonia (CABP) using 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, in either oral or IV doses or a combination of both.

Abstract: The present invention provides a novel therapeutic combination comprising one or more anti-androgen agents and one or more antibiotic/anti-inflammatory agents or pharmaceutically acceptable salts or hydrates thereof, useful for the treatment of a dermatological disorder.

Abstract: Simultaneous inhibition of the aryl hydrocarbon receptor (AhR) and SRC abolishing androgen receptor (AR) signaling in prostate cancer cells is disclosed herein as an effective treatment for prostate cancer. Provided herein is a therapeutic composition that comprises an aryl hydrocarbon receptor (AhR) antagonist and an SRC inhibitor. In one embodiment, the therapeutic composition further comprises a pharmaceutical excipient. In one embodiment, the AhR antagonist is CH223191 and the SRC inhibitor is PP2 and the therapeutic composition further comprises a pharmaceutical excipient. Methods of using the therapeutic composition to treat prostate cancer or to inhibit prostate cancer cells are also disclosed.

Abstract: The present invention relates to a method of treating patients who undergo hematopoietic stem cell transplantation (HSCT) with peripheral blood mobilized stem cells for hematological malignancies and for whom the risk for severe acute graft versus host disease (GVHD) is considerable.

Abstract: The present disclosure provides prodrugs of biologically active 2,4-pyrimidinediamine compounds, salts and hydrates of the prodrugs, compositions comprising the prodrugs, intermediates and methods for synthesizing the prodrugs and methods of using the prodrugs in a variety of applications.

Abstract: The present invention relates to stable pharmaceutical compositions of fosaprepitant or a salt thereof in the form of ready-to-use or ready-to-dilute compositions suitable for parenteral administration.

Abstract: Disclosed herein are methods of treating or preventing pain. Typically, a pharmaceutical composition having a therapeutically effective amount of the zoledronic acid is administered to a mammal suffering from pain. The pharmaceutical composition may further comprise an enhancer, which can be a medium chain fatty acid salt, an ester, an ether, or a derivative of a medium chain fatty acid and can have a carbon chain length of from about 4 to about 20 carbon atoms.

Abstract: Provided herein are compositions and methods related to use of oligosaccharides, such as 2?-fucosyllactose, for increasing weight gain in a subject. In some aspects the compositions and methods are for use in infants, such as premature infants or infants having intestinal failure.

Abstract: The present disclosure provides pharmaceutical compositions comprising cytidine analogs for oral administration, wherein the compositions release the cytidine analog substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.

Abstract: Polymeric compositions are provided that include a poly(ethylene glycol), a viscoelastic polymer, and an antioxidant, where, in polymerized form, the compositions have a refractive index of about 1.30 to about 1.40. Methods of synthesizing the compositions are also provided and include the steps of heating an amount of water; adding a buffering agent to the water to form a buffer solution; mixing a poly(ethylene glycol) and a viscoelastic polymer into the buffer solution to form a reactive mixture; adding a plurality of antioxidant particles to the reactive mixture; and removing suspended gas bubbles from the reactive mixture. Methods of preventing oxidative damage to an eye lens of a subject are further provided and include administering the foregoing polymeric compositions to the eye lens of the subject.

Abstract: A system for treating or providing prophylaxus against a pulmonary infection is disclosed comprising: a) a pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition, and b) an inhalation delivery device. A method for providing prophylaxis against a pulmonary infection in a patient and a method of reducing the loss of antiinfective encapsulated in a lipid-based composition upon nebulization comprising administering an aerosolized pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition is also disclosed.

Abstract: The present disclosure relates to RNAi agents useful in methods of treating KRAS-related diseases such as a proliferative disease, including without limitation a solid or liquid cancer, adenocarcinoma, colorectal cancer, advanced and/or metastatic colorectal cancer, colon cancer, lung, non-small cell lung cancer and lung adenocarcinoma, acute myelogenous lung, bladder, brain, breast, cervical, endometrial, gastric, head and neck, kidney, leukemia, myelodysplastic syndrome, myeloid leukemia, liver, melanoma, ovarian, pancreatic, prostate, testicular, thyroid cancers, and cardio-facio-cutaneous (CFC) syndrome and Noonan syndrome, and similar and related diseases, using a therapeutically effective amount of a RNAi agent to KRAS.

Abstract: A unit structure consists of a single nucleic acid having a length of 10 to 30 bases, and a single block copolymer having a cationic polyamino acid segment and a hydrophilic polymer chain segment. In this unit structure: (i) a difference between a total of positive charges derived from cationic groups of the cationic polyamino acid segment and a total of negative charges derived from the nucleic acid in the unit structure falls within a range of ±10% of the total of the negative charges derived from the nucleic acid, (ii) the hydrophilic polymer chain segment comprises polyethylene glycol, (iii) the polyethylene glycol has a radius of inertia (Rg) equal to or longer than the length of the nucleic acid, and (iv) the cationic polyamino acid segment is bound to the nucleic acid via electrostatic bonds.

Abstract: The present disclosure is in the field of diagnostics and therapeutics for Alzheimer's Disease.

Abstract: This current invention provides methods and agents for preventing and treating autoimmune and lymphoproliferative disease by targeting pathogenic age-associated B cells as well as methods of detecting these pathogenic age-associated B cells as a method of diagnosing and predicting autoimmune disease and other lymphoproliferative and chronic inflammatory disorders. The current invention also provides targets for drug development and basic research for autoimmune diseases and other lymphoproliferative and chronic inflammatory disorders.

Abstract: The present invention relates to the field of prebiotics. Provided are uses for compositions comprising synergistically effective amounts of polyfructose and galactooligosaccharides (GOS).

Abstract: Methods and compositions for increasing the growth rate of a prey fish are described. A method includes contacting the prey fish with a water-soluble growth promoting factor in an amount effective to increase the growth rate of the prey fish. The water-soluble growth promoting factor can be released through fish skin from the urine and/or feces of a predator fish that has eaten a prey fish. An aquaculture growth supplement includes a carrier and a water-soluble growth promoting factor. Also included are methods of making aquaculture growth supplements.

Abstract: The present invention relates to methods of managing weight, and treating overweight or obesity and treating or preventing diabetes in a subject in need thereof. In one embodiment, the method comprises the steps of (a) orally administering to the subject from about 0.7 g to about 4 g of crosslinked carboxymethylcellulose; and (b) orally administering to the subject at least about 100 mL of water per gram of crosslinked carboxymethylcellulose. Steps (a) and (b) are conducted prior to or with at least one meal per day.

Abstract: Disclosed herein are fully synthetic polymer-based lung surfactant materials, for the first time, as next generation SRT. In vitro studies on these polymer lung surfactants show that the candidate materials effectively mimic the surface tension controlling properties of currently marketed natural lung surfactants. Further, the polymer lung surfactants have strong protein resistance, which makes this class of materials promising also for potential use in Acute Respiratory Distress Syndrome (ARDS) treatment.

Abstract: The subject matter of the invention relates to the method of administering the polypropyleneimine dendrimer of the fourth generation, coated with maltotriose, of a general formula I, wherein 25 to 45% of R substituents stand for a maltotriose residue and each of the remaining R substituents is H, to a human subject. The dendrimer of the formula I is designated in short as PPI-G4-OS-Mal-III, where PPI-G4 stands for the 4th generation of polypropyleneimine dendrimer, OS (Open Shell)—for open coat, Mal-III for maltotriose (trisaccharide made of 3 ?-glucose residues).

Abstract: Non-natural oligomers have recently shown promise as functional analogues of lung surfactant proteins B and C (SP-B and SP-C), two helical and amphiphilic proteins that are critical for normal respiration. The generation of non-natural mimics of SP-B and SP-C has previously been restricted to step-by-step, sequence-specific synthesis, which results in discrete oligomers that are intended to manifest specific structural attributes. Presented herein an alternative approach to SP-B mimicry that is based on sequence-random copolymers containing cationic and lipophilic subunits. These materials, members of the nylon-3 family, are prepared by ring-opening polymerization of ?-lactams. The best of the nylon-3 polymers display promising in vitro surfactant activities in a mixed lipid film. Pulsating bubble surfactometry data indicate that films containing the most surface-active polymers attain adsorptive and dynamic-cycling properties that surpass those of discrete peptides intended to mimic SP-B.

Abstract: A composition and method of providing nitric oxide and nitrite therapy to patients whereby a therapeutic amount is bioavailable within approximately 30 minutes of administration. In embodiments of the invention, nitric oxide is produced in the oral cavity.

Abstract: The present invention provides compositions comprising amorphous calcium carbonate (ACC), suitable to being administered by inhalation, and methods for their use in treating ACC-responsive diseases and conditions. Further provided are ACC compositions suitable for buccal or sublingual administration.

Abstract: The present invention relates to a combination comprising cabazitaxel and cisplatin. The present invention relates also to a pharmaceutical composition containing such a combination and to a pharmaceutical kit comprising: (i) a first galenic formulation comprising cabazitaxel; and (ii) a second galenic formulation comprising cisplatin. The invention relates also to the use of this combination and/or pharmaceutical composition and/or pharmaceutical kit in the treatment of neoplastic diseases, more particularly in the treatment of cancer.

Abstract: The present invention relates to a method for maintaining the increased intracellular p53 level, induced by a platinum-based anticancer drug, and an application thereof and, more specifically, to a method for maintaining the increased intracellular p53 level in cells by administering a platinum-based anticancer drug and siRNA to ubiquitin ligase for p53 to a subject in need thereof in combination and sequentially, and a composition for promoting cancer cell apoptosis using the same. According to the method of the present invention, the increased intracellular p53 expression level can be maintained for a long period of time in spite of the treatment with a low-concentration platinum-based anticancer drug, thereby effectively inducing the apoptosis of cancer cells and minimizing the drug side effect caused by the administration of the platinum-based anticancer drug, and thus the present invention can be favorably used in the prevention of cancer or the development of cancer medicines.