Abstract: The present invention provides dry powder formulations for inhalation having improved moisture resistance such that the powders maintain a high fine particle dosage or fine particle fraction following storage under relatively extreme temperature and humidity conditions.

Abstract: The invention described herein relates to pharmaceutical compositions that are capable of delivering active pharmaceutical ingredients, such as estrogens, to the vagina and vagina-associated tissues and related methods of making and using such compositions (e.g., in the treatment of disease). Compositions of the invention are capable of being absorbed by the vagina or vagina-associated tissues such that subjects receiving treatment with the compositions may resume ambulatory activity immediately after receiving the treatment, the frequency or amount of discharge associated with the composition is low or negligible, there is little or no systemic absorption associated with the administration of the active pharmaceutical composition, or results in a combination of any or all thereof.

Abstract: Provided is a pharmaceutical composition which contains fulvestrant in an amount of equal to or greater than 8% by mass with respect to the entire mass of the pharmaceutical composition, an aqueous solvent satisfying (1) to (4), and a pharmaceutically acceptable nonaqueous carrier satisfying (A) and (B). (1) Ethanol is contained in an amount of equal to or greater than 8% by mass with respect to the entire mass of the pharmaceutical composition. (2) At least one kind of polyhydric alcohol selected from propylene glycol or 1,3-butylene glycol is contained in an amount of equal to or greater than 3% by mass with respect to the entire mass of the pharmaceutical composition. (3) A content of benzyl alcohol is less than 5% by mass with respect to the entire mass of the pharmaceutical composition. (4) A content of the aqueous solvent is 15% to 50% by mass with respect to the entire mass of the pharmaceutical composition.

Abstract: A method for contraception includes administering to a female daily, in a fourphasic dosing regimen during a time period of 24 successive days, an oral combination drug formulation of norethindrone acetate and ethinyl estradiol (EE), wherein doses in the second, third and fourth phases of the regimen increase by a predefined dose increment as compared to the corresponding doses administered during the previous phase, wherein the norethindrone acetate dose in the first phase is 1000 mcg, in the second phase is 1125 mcg, in the third phase is 1250 mcg, and in the fourth phase is 1375 mcg, wherein the EE dose in the first phase is 20 mcg, in the second phase is 22.5 mcg, in the third phase is 25 mcg, and in the fourth phase is 27.5 mcg, and wherein the fourphasic dosing regimen is followed by 4 days without norethindrone acetate and EE administration.

Abstract: Capsaicinoid formulations and methods of treatment are disclosed herein which can be utilized to treat/attenuate pain in mammals. Typically, administration is via injection at a discrete site to provide pain relief for an extended period of time. The formulations are administered in a pharmaceutically acceptable vehicle. The formulations include an analgesic agent in an amount sufficient to attenuate the burning and hyperalgesic effects of capsaicinoid administration. The invention also includes a method of treating pain by administering a corticosteroid followed by administration of a capsaicinoid.

Abstract: [Problem] To provide a therapeutic agent for estrogen-dependent gynecological diseases such as endometriosis, uterine fibroids, and uterus adenomyosis. [Solution] To use an estrogen receptor ?-inhibiting ? partial agonist represented by the formula (a), a pharmaceutically-acceptable salt thereof, or a hydrate of either of the afore-mentioned, as an active ingredient.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: The disclosure is directed to methods of treating subjects infected with HIV, once daily, with single unit dosage forms that include darunavir (or a hydrate or solvate thereof), cobicistat, emtricitabine, and a tenofovir prodrug, or salt thereof.

Abstract: The present invention relates methods and compositions for reducing body weight and increasing gut motility using D-ribose or an analog or derivative thereof.

Abstract: The present invention is directed to 4?-substituted nucleoside derivatives of Formula (I) and their use in the inhibition of HIV reverse transcriptase, the prophylaxis of infection by HIV, the treatment of infection by HIV, and the prophylaxis, treatment, and delay in the onset or progression of AIDS and/or ARC. The present invention also provides processes for the preparation of 4?-substituted nucleoside derivatives of Formula (I) and derivatives thereof.

Abstract: This disclosure relates to N4-hydroxycytidine derivatives, compositions, and methods related thereto. In certain embodiments, the disclosure relates to the treatment and prophylaxis of viral infections.

Abstract: This invention relates to a combination of gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate (chemical name: 2?-Deoxy-2?,2?-difluoro-D-cytidine-5?-O-[phenyl (benzoxy-L-alaninyl)] phosphate) (NUC-1031) and a platinum-based anticancer agent selected from cisplatin, picoplatin, lipoplatin and triplatin. The combinations are useful in the treatment of cancer, particularly biliary tract and bladder cancer.

Abstract: This invention relates to pharmaceutical formulations of gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate, a monophosphate derivative of the well-known oncology drug gemcitabine. In particular, the invention relates to formulations which comprise a polar aprotic solvent, preferably dimethyl acetamide (DMA). Formulations comprising this solvent provide therapeutically effective treatments of gemcitabine-[phenyl-(benzoxy-L-alaninyl)]-phosphate. The invention also relates to methods of using said formulations and kits comprising said formulations.

Abstract: Provided herein are compositions and formulations comprising S-adenosyl-L-methionine (“SAM-e” or “SAMe”) and one or more gallic acid esters. Also provided herein are methods for improving the delivery of SAMe. Compositions and formulations provided herein increase SAMe plasma concentrations and area under the curve (AUC) values. Also provided herein are methods of treating a disease or disorder in a subject by administering compositions or formulations comprising exogenous SAMe and one or more gallic acid esters.

Abstract: The present invention provides an application of triacetyl-3-hydroxyphenyladenosine represented by formula (I) in preventing or treating non-alcoholic fatty liver disease. The triacetyl-3-hydroxyphenyladenosine can significantly reduce the levels of serum AST, ALT and TG, significantly improve liver functions, and alleviate liver steatosis. The invention provides significant curative effects for preventing or treating non-alcoholic fatty liver and has limited toxic side effects.

Abstract: Various embodiments disclosed herein include methods of modulating the function of Zinc Activated Cation Channel (ZACN) in a subject comprising: administering to the subject a pharmaceutically effective dosage of ATP, a purinergic compound, red or blue dye, heparin or heparin analog, desipramine, reboxetine, and/or tomoxetine; and modulating the function of ZACN in the subject. Various embodiments disclosed herein also include methods of treating a disease in a subject comprising: administering to the subject a pharmaceutically effective dosage of a compound capable of modulating the function of the Zinc Activated Cation Channel (ZACN), and treating the disease.

Abstract: The present invention relates to the field of medicine. It relates more particularly to the use of compounds for preventing and/or treating, in a subject, myopathy, typically muscular dystrophy or cardiomyopathy, or muscular trauma. The invention also relates to the compositions, in particular pharmaceutical compositions comprising such compounds, as well as their uses for preventing and/or treating muscular myopathy or trauma. The compounds and compositions according to the invention may typically be advantageously used to prevent and/or treat muscular dystrophy, cardiomyopathy or muscular trauma, preferably Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD) and/or a characteristic symptom or anomaly of DMD or BMD.

Abstract: Described are compositions and methods for inhibition of Hepatitis B virus gene expression. RNA interference (RNAi) triggers and RNAi trigger conjugates for inhibiting the expression of Hepatitis B virus gene are described. Pharmaceutical compositions comprising one or more HBV RNAi triggers optionally with one or more additional therapeutics are also described. Delivery of the described HBV RNAi triggers to infected liver in vivo provides for inhibition of HBV gene expression and treatment.

Abstract: This disclosure relates to RNA interference (RNAi) reagents for treatment of hepatitis B virus (HBV) infection, compositions comprising same, and use thereof to treat individuals infected with HBV.

Abstract: Methods and compositions for increasing the suppressive function of regulatory T-cells (Tregs) are provided.

Abstract: The present invention relates to an antiviral drug comprising as an active ingredient a substance capable of suppressing an expression of a target gene or an activity of a protein encoded by said target gene, wherein said target gene is one or more genes having an action of retaining virus-derived nucleic acid in a host cell and selected from the group consisting of DOCK11 gene, LIPG gene, DENND2A gene, and HECW2 gene. The present invention also relates to a screening method for the antiviral drug.

Abstract: The invention is related to LncHIFCAR (long noncoding HIF-1? co-activating RNA)/MIR31HG and its applications in cancer diagnosis, cancer therapy, prognosis predication of a cancer and determination of therapeutic regimen of a cancer. The present invention identifies a hypoxia-inducible lncRNA, LncHIFCAR (long noncoding HIF-1? co-activating RNA)/MIR31HG, and describes its oncogenic role as a HIF-1? co-activator that regulates the HIF-1 transcriptional network, crucial for cancer development.

Abstract: Provided herein are compounds, compositions and methods for balancing a T-helper cell profile and in particular Th1, Th2, Th17 and Treg cell profiles, and related methods and compositions for treating or preventing an inflammatory condition associated with an imbalance of a T-helper cell profile.

Abstract: This disclosure relates to soluble ?-glucan immunotherapies that affect the tumor microenvironment. The soluble ?-glucan immunotherapies promote an immunostimulatory environment, which enhances the effectiveness of the combination of anti-angiogenics and checkpoint inhibitors.

Abstract: An injectable monophase hydrogel is provided that is made of a reaction mixture of hyaluronic acids having different molecular weights.

Abstract: The present invention relates to pharmaceutical formulations comprising at least one acid-labile proton pump inhibiting agent and at least one antacid, which have improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties. The present invention is directed to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a gastrointestinal disorder or disease, or the symptoms associated with, or related to, a gastrointestinal disorder or disease in a subject in need thereof.

Abstract: A method of treating a patient having a lung condition that includes identifying a target haemoglobin-carbon monoxide level in the blood of the patient. The method also includes administering, to the patient, carbon monoxide at a first concentration for an initial time period, and measuring the haemoglobin-carbon monoxide level in the blood of the patient. The method also includes calculating, based on the measured haemoglobin-carbon monoxide level and the target haemoglobin-carbon monoxide level, a dose of carbon monoxide required to attain the target haemoglobin-carbon monoxide level within a determined time period. The method also includes administering, to the patient, the calculated dose of carbon monoxide for the determined time period to attain the target haemoglobin-carbon monoxide level in the blood of the patient.

Abstract: Provided are methods for treating calcium malabsorption and conditions associated with calcium malabsorption, employing the administration of a composition containing stable amorphous calcium carbonate. Further provided are methods for increasing bone mineral density in a bone metabolism associated disorders, diseases or conditions, employing the administration of said composition in combination with a bone resorption inhibitor.

Abstract: Methods and compositions for treating various indications by lessening oxidative stress in a patient are provided. A pharmaceutical composition comprises between about 0.001% to about 10.0%, or more specifically between about 0.015% to about 5%, sodium iodide or catalase by weight. The iodine ion or the catalase dissociates hydrogen peroxide into water and molecular oxygen to interrupt biological events that result in negative side effects. The pharmaceutical composition further comprises in some cases a reducing agent or various carrier materials. The pharmaceutical composition is in some cases formulated for a variety of delivery methods.

Abstract: The present disclosure relates to compositions for the treatment of chitin-containing microorganism infection or colonization of an animal. The methods, systems and kits provided herein facilitate termination and/or inhibition of proliferation of chitin-containing microorganisms (e.g., Saprolegnia and sea lice).

Abstract: Sterile micron-sized gold particles contained in capped vials, a kit of part including the vial and a liquid capable of suspending the particles, as well as their preparation, medical devices or medicaments prepared by their preparation as well as uses thereof in treating inflammation. Also, gold coated implants preferably for use in combination with the medical devices.

Abstract: Composition for strengthening the immune system and method of preparation of the same are disclosed herein. The disclosed herbal composition includes gold particles and honey which facilitate in boosting the immune system and overall health. It is believed to improve the physical and mental health of an individual. The disclosed composition is instrumental as immune stimulating and memory boosting agent.

Abstract: The present invention generally relates to iron-polysaccharide (polydextrose) complexes and methods for the preparation thereof. In particular, the present invention relates to iron-polydextrose complexes and methods for the preparation thereof. The inventive complexes are suitable for use in various compositions, including particulate compositions that may be incorporated in various forms of administration, including tablets, capsules, and intravenous formulations. The complexes and compositions of the present invention are suitable for use in the treatment of iron deficient anemia. Advantageously, in addition to providing iron supplementation the complexes and compositions of the present invention provide certain advantages based on the presence of polydextrose (e.g., its low glycemic index and high fiber content).

Abstract: The present invention relates to the use of pharmaceutically acceptable zinc salts, preferably water soluble zinc salts alone or optionally, in combination with one or more of a protein pump inhibitor (PPI), H2 blocker, anti-H. pylori antibiotic/antimicrobial, cytoprotective agent or a combination agent as otherwise described herein for providing fast action with optional long duration effect in reducing gastric acid secretion, raising the pH of the stomach during resting phase as well as decreasing the duration of stomach acid release during a secretagogue phase and for treating conditions including gastroesophageal reflux disease (GERD), non-erosive reflux disease (NERD), Zollinger-Ellison syndrome (ZE disease), ulcer disease, and gastric cancer, as well as preventing or reducing the likelihood of ulcer disease.

Abstract: The present invention relates to a composition for the synthesis of ATP as an energy supplementation. The composition comprises a plant extract or a plant fraction suitable to produce ATP upon exposure to light. The present invention also relates to the isolation of such plant extract and to its use in energy drinks.

Abstract: Nanosecond pulsed electric field (nsPEF) treatments of a tumor are adjusted based on a size and type of the tumor to stimulate an immune response against the tumor and other tumors in the subject. Calreticulin expression on tumor cells can be detected to confirm treatment. An immune response biomarker can be measured, and further nsPEF treatments can be performed if needed to stimulate or further stimulate the immune response. Cancers that have metastasized may be treated by directly treating a tumor that is most accessible. The treatment can be combined with CD47-blocking antibodies, doxorubicin, CTLA-4-blocking antibodies, and/or PD-1-blocking antibodies. Electrical characteristics of nsPEF treatments can be based on the size, type, and/or strength of tumors and/or a quantity of tumors in the subject.

Abstract: Provided herein are methods for treating an individual for a disease (e.g., an autoimmune disease or a cancer) using an active agent which affects metabolism of ?-ketoglutarate (?-KG) and/or 2-hydroxyglutarate (2-HG) in differentiating T cells. In some embodiments, a Got1 inhibitor is used to generate a population of T cells enriched in peripheral regulatory T (iTreg) cells, which population enriched in iTreg cells may find use in treating an autoimmune disease. In some embodiments, a TCA cycle-associated metabolite, or a derivative thereof, is used to generate a population of T cells in enriched in IL-17- and IL-17F-producing CD4 T (TH17) cells, which population enriched in TH17 cells may find use in treating a cancer.

Abstract: The present application is directed to compositions and methods for treating a subject with cancer and/or increasing migration of a mesenchymal stromal cells (MSCs) stimulated with a recombinant autocrine motility factor (rAMF) to a tumor or a tumor cell, e.g. hepatocellular carcinoma (HCC). In addition, methods for increasing adhesion of MSCs to endothelial cells with rAMF are disclosed. In some embodiments, the MSCs comprise a therapeutic agent, e.g., an anti-tumor agent.

Abstract: The present invention relates to a composition and a method for inducing CD4+ T cells to differentiate into regulatory T cells and proliferate through an induced T cell co-stimulator ligand (ICOSL) or an ICOSL-overexpressing mesenchymal stem cell and for preventing or treating regulatory T cell-mediated diseases. The induced T cell co-stimulator ligand (ICOSL) or ICOSL-overexpressing mesenchymal stem cell according to the present invention effectively suppresses the proliferation of PBMCs, induces the expression of an ICOS in regulatory T cells, thereby inducing the differentiation and proliferation of the regulatory T cells through a PI3K-Akt mechanism, and thus can effectively prevent, treat, or enhance regulatory T cell-mediated diseases.

Abstract: The present disclosure concerns at least methods and compositions for repairing and/or regenerating a disc of an individual in need thereof. In certain embodiments, an individual that is known to have or suspected to have or at risk for having a degenerated disc is provided a therapeutically effective amount of nucleus pulposus cells, one or more components from the nucleus pulposus, conditioned medium generated from nucleus pulposus cells, and additionally may also be provided fibroblasts, platelet rich plasma (PRP), SOX9 (protein or nucleic acid), and/or Tie2+ cells, for example.

Abstract: Disclosed herewith is a method for inducing angiogenesis using modified placental tissue or an extract thereof to treat conditions other than cardiovascular conditions.

Abstract: Disclosed are compositions of matter, therapeutic protocols, and cellular reprogramming means to inhibit glioma or other brain neoplasia. In one embodiment the invention provides administration of amniotic fluid derived stem cells at concentrations of 1 million to 200 million administered in a manner to provide a differentiation stimulation, resulting in reduction of malignant potential. In other embodiments, an unexpected synergy of cancer inhibitory soluble factor production is disclosed by combined cultures between amniotic fluid stem cells and monocytes. In all embodiments cells may be autologous or allogeneic. The invention provides means of augmenting efficacy of immunotherapy, chemotherapy, and radiotherapy.

Abstract: The present invention relates to a composition for preventing or treating ischemic enteritis containing a DNA fragment mixture isolated from sperm or testis of fish. The composition of the present invention was verified to have excellent effects in the prevention or treatment of ischemic enteritis. In addition, the composition for preventing or treating ischemic enteritis of the present invention was verified to be safe and have few side effects even when administered for a long period of time. Therefore, a medicine for ischemic enteritis, which is safe without side effects and has an excellent treatment effect, is developed by using the composition for preventing or treating ischemic enteritis of the present invention, and thus the composition of the present invention is expected to be a great help in the treatment of ischemic enteritis.

Abstract: The present invention is directed to a medicated oil composition comprising propolis, about 1-40% by weight, a carrier, about 30-90% by weight, an analgesic, about 0.1-10% by weight, a surfactant, about 0.25-20% by weight, and a diluent, about 5-50% by weight.

Abstract: Medicated honey and method of preparing the same are disclosed herein. The disclosed honey is obtained by feeding honeybees with bee-feed obtained from medicinal plants. The medicated honey disclosed herein is such that it has anti-oxidant and anti-cancer properties. The embodiments disclosed herein may be instrumental in strengthening the immune system, as an anti-cancer agent and as an anti-oxidant.

Abstract: A method and system for the treatment of honey bees (Apis mellifera), bats, and butterflies protects them from various life threatening conditions, including Colony Collapse Disorder, white nose syndrome, etc. and in particular, provides honey bees, bats and butterflies with the ability to assimilate and degrade neonicotinoids.

Abstract: A method of determining tolerance to an agent in a healthy subject is disclosed. The method comprises: (a) determining a signature of a microbiome in a sample of the healthy subject who has been subjected to the agent or condition; and (b) comparing the signature of the microbiome of the healthy subject to at least one reference signature of a pathological microbiome, wherein when the signature of the microbiome of the healthy subject is statistically significantly similar to the reference signature of the pathological microbiome, it is indicative that the healthy subject is intolerant to the agent.

Abstract: The present invention provides a stable liquid syrup composition compositions comprising probiotic bacteria, retaining their cellular viability at ambient storage conditions for at least two years.

Abstract: Provided herein are compositions and methods for the treatment of type 1 diabetes (T1D) in mammalian subjects. The compositions include lactic acid fermenting bacteria (LAB) expressing an IL-2 gene and a T1D-specific self-antigen (e.g., proinsulin (PINS)) gene. Exemplary methods include: orally administering to a mammalian subject, a therapeutically effective amount of the composition. The composition can be administered to the subject mucosally, resulting in delivery of the LAB into the gastrointestinal tract, where the LAB is released. Bioactive polypeptides expressed by the LAB are thus administered via mucosal delivery. The LAB may be selected to deliver a low-dose of IL-2 to the subject. The methods may not require concomitant systemic anti-CD3 antibody treatment. The methods may be suited for subjects possessing residual beta-cell function, e.g., those with recent-onset T1D.

Abstract: Provided are engineered phages populations, which are homogeneous in length, as well as methods of making and methods of using such phages. Also provided are engineered chlorotoxin -phages as well as their methods of making and using. The disclosed homogeneous phage populations and chlorotoxin-phages may be used, for example, for treating and/or imaging tumors, such as central nervous system tumors.