Abstract: The disclosure provides, in part, follistatin polypeptides that are suitable for use in local administration and methods for use.

Abstract: The present invention relates to microneedle vaccine formulations, as well as methods of use thereof to provide animals, including canines, protective immunity against infection and disease caused by rabies viruses. Once placed onto the skin of the animals, the microneedle formulations dissolve quickly into the surrounding skin, where the antigens then elicit in the animals high and protective levels of rabies virus neutralizing antibodies.

Abstract: Implantable compositions providing release of bioactive agents according to a predetermined release profile and methods for their use. Such compositions include at least one ceramic substrate; a bioactive substance loaded on a surface of the ceramic substrate forming a loaded surface zone operable to release said bioactive substance according to a release profile under physiological conditions; and a biodegradable polymer having an in vivo degradation period, forming a continuous or discontinuous coating on an area of the ceramic substrate.

Abstract: A method (and the resulting product) of making a medical implant device for releasing self-contained drugs on a controlled basis wherein the method utilizes, at least in part, computer-controlled 3-D printing equipment to deposit via nozzles portions of one or more layers of the medical implant product. The implant has an outer impervious coating, an inner matrix core, an opening and an optional bonding layer.

Abstract: A non-degradable topical ocular drug delivery device includes about 0.001% to about 10% w/w of at least one myopia-suppressing agent complexed with an immobile acid within a crosslinked polymer matrix. The cross-linked polymer matrix is configured to deliver the least one myopia-suppressing agent over an extended period of time at a concentration and rate that controls myopia progression while preserving pupillary function and accommodation.

Abstract: This invention provides compositions comprising a protein, an absorption enhancer, a protease inhibitor, method for treating diabetes mellitus, comprising administering same, and methods for oral administration of a protein with an enzymatic activity, comprising orally administering same.

Abstract: The present invention relates to compositions and methods for treatment of proliferative disease. In specific aspects, the present invention relates to compositions including celecoxib and plumbagin in combination; methods for treatment of a proliferative disease including administration of celecoxib and plumbagin in a subject in need thereof; and particularly methods for treatment of skin cancer including administration of celecoxib and plumbagin in a subject in need thereof.

Abstract: New liposomes are described, comprising: (i) phosphatidic acid and/or cardiolipin; (ii) apolipoprotein E (ApoE) or derivatives thereof. The so modified liposomes, administered systemically, obtain a dramatic in-vivo reduction of the amyloid plaque in the central nervous system, allowing an effective treatment of neurodegenerative diseases, in particular Alzheimer's disease.

Abstract: The invention relates to matrix and layer compositions comprising a first polymer. The matrix and layer compositions are useful in the delivery of bioactives. In particular, the matrices and layers may have advantageous properties including mechanical properties and protection of bioactives and may also provide for pH-dependent release of a bioactive.

Abstract: Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.

Abstract: 11-mercaptoundecyl trimethylammonium bromide gold nanorod (MTAB-GNR) coated with tannic acid (TA), useful for biological cellular imaging. A method of synthesizing tannic acid-coated 11-mercaptoundecyl trimethylammonium bromide gold nanorods (MTAB-TA GNRs) comprising presenting 11-mercaptoundecyl trimethylammonium bromide gold nanorods (MTAB-GNRs) in solution; functionalizing the MTAB-GNRs with tannic acid (TA) added to the MTAB-GNRs, the tannic acid configured to form a coating around the MTAB-GNRs forming MTAB-TA GNRs. The functionalizing step may further comprise adding a sodium chloride solution to the MTAB-TA GNR solution, and/or adding a MOPS buffer to the solution of tannic acid with MTAB-GNRs, and the tannic acid MTAB-GNR solution may be vortexed after each step.

Abstract: An apparatus for producing a controlled dosage of bioactive agent is disclosed.

Abstract: Described herein are oral pharmaceutical formulations comprising a core component and a coating composition applied on the core component. Also described is a process for producing said oral pharmaceutical formulations.

Abstract: A transdermal drug delivery system is provided that includes a drug-in-adhesive matrix layer and a backing layer. The matrix layer includes an active pharmaceutical ingredient, a cross-linked polyvinylpyrrolidone binder, a mesoporous silicon dioxide filler, and a pressure sensitive adhesive, while the backing layer forms an exterior facing-surface of the delivery system. The ratio of the mesoporous silicon dioxide filler to the cross-linked polyvinylpyrrolidone binder ranges from about 1:1 to about 1:8. As a result of the specific components of the matrix layer and the amounts in which they are utilized, the resulting delivery system, which can include a homogeneous dispersion of the active pharmaceutical ingredient in the formulation, is capable of delivering the active pharmaceutical ingredient over a period of up to about 7 days in a generally constant and controlled fashion. Further, the only layer that contemplates the use of an adhesive component is the drug-in-adhesive matrix layer.

Abstract: This invention relates to pharmaceutical composition and methods of using vitamin A and/or RAR? agonist for the treatment or prevention of diseases or conditions associated with high fat diet and/or vitamin deficiency.

Abstract: The present invention is directed to an aqueous pharmaceutical composition, particularly an aqueous ophthalmic composition, suitable as an injection, particularly an intravitreal injection. The composition includes a biologic therapeutic agent (e.g., an isolated monoclonal antibody that specifically binds to a C5 protein) that tends to raise the viscosity of the composition and a guanidine and/or guanidine derivative (e.g., L-arginine) that tends to lower the viscosity of the composition.

Abstract: Methods and compositions for reducing frequency of urination are disclosed. The methods comprise administering to a subject having a condition that resulting in undesired frequency of urination an effective amount of a pharmaceutical composition comprising one or more prostaglandin pathway inhibitors. The pharmaceutical compositions comprise one or more prostaglandin pathway inhibitors and a pharmaceutically acceptable carrier.

Abstract: The present invention relates to compositions and methods for the treatment of Parkinson's disease and related disorders. More specifically, the present invention relates to novel combinatorial therapies of Parkinson's disease and related disorders targeting the alpha-synuclein aggregation network. In particular, the invention relates to compounds which, alone or in combination(s), can effectively protect neuronal cells from alpha-synuclein aggregates. The invention also relates to methods of producing a drug or a drug combination for treating Parkinson's disease and to methods of treating Parkinson's disease or a related disorder.

Abstract: Here provided is a method for regulating retinal endothelial cell viability in a mammal by administering to the mammal a therapeutically effective amount of a quinic acid analog. The method may be applied to prevent, treat or cure pathological conditions of retinal endothelial cells associated with radiation retinopathy, diabetic retinopathy and chemotherapy for retinoblastoma.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: Prostacyclin compounds and compositions comprising the same are provided herein. Specifically, prostacyclin compounds comprising treprostinil covalently linked to a linear C5-C18 alkyl, branched C5-C18 alkyl, linear C2-C18 alkenyl, branched C3-C18 alkenyl, aryl, aryl-C1-C18 alkyl or an amino acid or a peptide (e.g., dipeptide, tripeptide, tetrapeptide) are described. The linkage, in one embodiment, is via a carbamate, amide or ester bond. Prostacyclin compounds provided herein can also include at least one hydrogen atom substituted with at least one deuterium atom. Methods for treating pulmonary hypertension (e.g., pulmonary arterial hypertension) and portopulmonary hypertension are also provided.

Abstract: Methods and compositions containing a phorbol ester or a derivative of a phorbol ester are provided for the treatment and prevention of stroke and the sequelae of stroke. Additional compositions and methods are provided which employ a phorbol ester or derivative compound in combination with at least one additional agent to yield more effective treatment tools to treat or prevent stroke and the long term effects of stroke in mammalian subjects.

Abstract: The present invention relates to a combined application of isothiocyanate compounds and anti-cancer drugs, in particular to a composition, comprising: (A) a therapeutically effective amount of a first active ingredient, the first active ingredient being an isothiocyanate compound or derivative thereof; (B) a therapeutically effective amount of a second active ingredient, the second active ingredient being anti-cancer drugs effecting or influencing DNA, kinase inhibitor anti-cancer drugs or endocrine therapy hormonal anti-cancer drugs, the mass ratio of the first active ingredient and the second active ingredient being from 1:10000 to 10000:1. Also disclosed are an active ingredient composition, kit, pharmaceutical composition and uses thereof in the preparation of anti-cancer drugs. The composition, active ingredient composition and kit have excellent effect of inhibiting the growth of cancer cells.

Abstract: This invention is directed to substituted acylanilide compounds and uses thereof in improving or preserving lung function and cardiac function in a subject suffering from Duchenne muscular dystrophy.

Abstract: The present invention relates to the use of a pharmaceutically effective amount of an short-acting calcium channel blocking compound to treat ischemic heart conditions, cardiac arrhythmias, hypertensive crisis in an emergency room setting, hypertension before, during, or after surgery, no-reflow phenomenon following reperfusion, and diseases associated with decreased skeletal muscle blood flow. The invention also relates to pharmaceutical compositions formulated for use in such methods and to kits for such methods.

Abstract: The present invention relates to the use of a pharmaceutically effective amount of an short-acting calcium channel blocking compound to treat ischemic heart conditions, cardiac arrhythmias, hypertensive crisis in an emergency room setting, hypertension before, during, or after surgery, no-reflow phenomenon following reperfusion, and diseases associated with decreased skeletal muscle blood flow. The invention also relates to pharmaceutical compositions formulated for use in such methods and to kits for such methods.

Abstract: The present invention relates to the use of a pharmaceutically effective amount of an short-acting calcium channel blocking compound to treat ischemic heart conditions, cardiac arrhythmias, hypertensive crisis in an emergency room setting, hypertension before, during, or after surgery, no-reflow phenomenon following reperfusion, and diseases associated with decreased skeletal muscle blood flow. The invention also relates to pharmaceutical compositions formulated for use in such methods and to kits for such methods.

Abstract: The present invention provides methods for determining the selectivity of an anesthetic for an anesthetic-sensitive receptor by determining the molar water solubility of the anesthetic. The invention further provides methods for modulating the selectivity of an anesthetic for an anesthetic-sensitive receptor by altering or modifying the anesthetic to have higher or lower water solubility. The invention further provides methods of inducing anesthesia in a subject by administering via the respiratory pathways (e.g., via inhalational or pulmonary delivery) an effective amount of an anesthetic compound identified according to the present methods.

Abstract: In certain embodiments, the disclosure relates to heterocyclic flavone derivatives, such as those described by formula provided herein, pharmaceutical compositions, and methods related thereto. In certain embodiments, the disclosure relates to methods of treating or preventing diseases or conditions related to BDNF and TrkB activity, such as depression, stroke, Rett syndrome, Parkinson's disease, and Alzheimer's disease by administering effective amounts of pharmaceutical compositions comprising compounds disclosed herein.

Abstract: The present invention is directed to active metabolite of 1-[(2-bromophenyl)sulfonyl]-5-methoxy-3-[(4-methyl-1-piperazinyl)methyl]-1H-indole dimesylate monohydrate of formula (I). The present invention is also directed to dimesylate dihydrate salt of formula (II). The compounds of formula (I) and formula (II) are useful in the treatment of various disorders that are related to 5-HT6 receptor antagonist.

Abstract: The present invention provides extended release pharmaceutical formulations of valsartan with controlled impurity levels. Particularly, the present invention provides extended release valsartan formulation which is substantially free of valsartan R-isomer impurity.

Abstract: The present disclosure relates to solid crystalline forms of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) and the diastereomers thereof, and to methods for preparing such crystalline forms. Compound (I) and the diastereomers thereof are potent androgen receptor (AR) modulators useful as a medicament.

Abstract: The present invention provides methods for treating and preventing the reoccurrence of C. diff infection by administering an immunoglobulin concentrate in conjunction with a low protein diet.

Abstract: The present technology provides compositions and methods for treating chronic kidney disease, end-stage renal disease, or diabetic nephropathy. The compositions comprise a nitrated lipid and an inhibitor of the renin-angiotensin-aldosterone system. The methods comprise administering a nitrated lipid in combination with an inhibitor of the renin-angiotensin-aldosterone system to a subject in need thereof, in an amount effective to treat diabetic nephropathy, chronic kidney disease, and/or end-stage renal disease. The use of a nitrated lipid with an inhibitor of the renin-angiotensin-aldosterone system exhibits a synergistic effect in treating chronic kidney disease and diabetic nephropathy.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: Certain embodiments are directed to a GMC1 co-solvent formulation. The GMC1 co-solvent formulation described herein can be used for the treatment of prostate cancer, benign prostatic hypertrophy, and other hormone-related conditions involving androgen, glucocorticoid, and progesterone receptors.

Abstract: Iron overload is associated with pathological conditions such as oxidative stress, transfusional iron overload, thalassemia, primary hemochromatosis, secondary hemochromatosis, diabetes, liver disease, heart disease, cancer, radiation injury, neurological or neurodegenerative disorder, Friedreich's ataxia (FRDA), macular degeneration, closed head injury, irritable bowel disease, and reperfusion injury. The present invention provides methods and pharmaceutical compositions using desferrithiocin analogs of Formulae (A) and (J) for treating and/or preventing these pathological conditions, metal (e.g., iron, aluminum, a lanthanide, or an actinide (e.g., uranium)) overload conditions, and infectious diseases (e.g., malaria).

Abstract: Disclosed are methods of modulating a stress activated protein kinase (SAPK) system with an active compound, wherein the active compound exhibits low potency for inhibition of at least one p38 MAPK; and wherein the contacting is conducted at a SAPK-modulating concentration that is at a low percentage inhibitory concentration for inhibition of the at least one p38 MAPK by the compound. Also disclosed are derivatives of pirfenidone. These derivatives can modulate a stress activated protein kinase (SAPK) system.

Abstract: Pharmaceutical formulations comprising clevidipine and an antimicrobial agent exhibit a reduced propensity for microbial growth and provide increased convenience to health care workers administering clevidipine-containing formulations to patients.

Abstract: This invention is directed to compounds and salts that are generally useful as agents to treat an infection with Dirofilaria immitis. This invention also is directed to treatments comprising the administration of the compounds and salts to animals in need of the treatments.

Abstract: The present invention is directed to pyrazole, triazole and tetrazole compounds which are antagonists of orexin receptors. Such compounds are of the general structural formula I: The present invention is also directed to uses of the compounds described herein in the potential treatment or prevention of neurological and psychiatric disorders and diseases in which orexin receptors are involved. The present invention is also directed to pharmaceutical compositions comprising these compounds. The present invention is also directed to uses of these pharmaceutical compositions in the prevention or treatment of such diseases in which orexin receptors are involved.

Abstract: The present invention provides an aminopyridine compound, or a pharmaceutically acceptable salt thereof, that inhibits Aurora A and, therefore may be useful in treating cancer.

Abstract: Compositions and methods are provided for modulating the physiological activation of tissue transglutaminase (TG2); which methods can include inhibiting the activity of TG2 associated with inflammatory disorders, which disorders may include, without limitation, sepsis, ischemic reperfusion injury, renal fibrosis, and the like.

Abstract: A novel compound, (E)-1-(pyridyn-4-yl)-3-(7-(trifluoromethyl)quinolin-2-yl)-prop-2-en-1-one, is provided herein. (E)-1-(pyridyn-4-yl)-3-(7-(trifluoromethyl)quinolin-2-yl)-prop-2-en-1-one is an inhibitor of 6-phosphofructo-2-kinase/fructose-2,6-biphosphatase 3 (PFKFB3) with surprisingly superior efficacy and pharmacodynamic properties in vitro and in vivo. Also provided are pharmaceutical compositions including the compound and methods of use of the compound in treating cancer and tumors in vivo, as well as inhibiting glycolytic flux and PFKFB3 enzymatic activity in cells.

Abstract: The disclosure generally relates to tamper-resistant transdermal dosage forms. The dosage forms can comprise an active agent and more than one antagonist reservoir.

Abstract: The present invention relates to modified or polymer conjugated MetAP2 inhibitors. The present invention also relates to methods of preventing, inducing, causing or increasing weight loss, treating obesity and/or treating metabolic syndrome utilizing the modified or polymer conjugated MetAP2 inhibitors. The present invention also relates to methods of improving insulin sensitivity and glycemic control, reducing insulin levels and/or improving leptin sensitivity utilizing the modified or polymer conjugated MetAP2 inhibitors.

Abstract: Embodiments of the present disclosure provide for compositions including an antibiotic containing a N-thiolated beta-lactam moiety, pharmaceutical compositions including the antibiotic, methods of treatment of a condition (e.g., bacterial infection), methods of treatment using compositions or pharmaceutical compositions, and the like.

Abstract: Methods are provided herein for selectively killing senescent cells and for treating senescence-associated diseases and disorders by administering a senolytic agent. Senescence-associated diseases and disorders treatable by the methods using the senolytic agents described herein include cardiovascular diseases and disorders associated with or caused by arteriosclerosis, such as atherosclerosis; idiopathic pulmonary fibrosis; chronic obstructive pulmonary disease; osteoarthritis; senescence-associated ophthalmic diseases and disorders; and senescence-associated dermatological diseases and disorders.

Abstract: This invention relates to compounds that inhibit or modulate the activity of Chk-1 kinase. Also provided are pharmaceutical compositions containing the compounds and the therapeutic uses of the compounds.

Abstract: The present invention provides 2,4-disubstituted pyrimidine compounds useful as kinase inhibitors, pharmaceutically acceptable compositions thereof, and methods of using the same.