Abstract: The present invention provides novel biomaterial compositions and methods having a technology to improve retention of hyaluronic acid (HA). The biomaterial compositions utilize small HA binding peptides and extracellular matrix binding (ECM) peptides that are tethered to synthetic biocompatible polymers. When tethered to the polymers, the peptide region allows the polymers to bind to HA and to tissues such as cartilage. The novel biomaterial compositions can be used to coat or chemically modify cartilage or tissues with a biologically compatible polymer having HA binding peptides, which allow HA to bind to the surface of the cartilage or tissues. Methods of using same are also provided.

Abstract: Delivery systems and compositions comprised of a biodegradable polyorthoester polymer, an organic acid excipient, and a basic drug are described, along with related methods.

Abstract: A trans-mucosal testosterone delivery composition for humans or animals having from about 50 to 99 wt. % humectant, from about 1 to 50 wt. % water, from about 0.001 to 25.00 wt. % testosterone, from about 0 to 25 wt. % oil, and from about 25 to 1 wt. % surfactant, wherein the composition is hydrophobic and has release properties.

Abstract: The present invention discloses the use of paricalcitol, a synthetic Vitamin D analogue, in the treatment of inflammatory anaemia, preferably in combination with erythropoeisis-stimulating agents. The use of paricalcitol in the treatment of said pathology is associated with a reduced requirement for erythropoeisis-stimulating agents, with optimised iron absorption and with an increase in plasma erythropoietin levels in said patients. The present invention also discloses pharmaceutical compositions that comprise paricalcitol in combination with erythropoeisis-stimulating agents and pharmaceutically acceptable excipients, in addition to the use thereof as drugs in the treatment of inflammatory anaemia.

Abstract: Provided herein are, inter alia, methods and compositions for treating cancer in a subject in need thereof comprising a therapeutically effective amount of a stilbenoid compound and a progestin.

Abstract: Novel multi-component formulations, procedures and methods for use in treating neuropathology and neurodegeneration incident to trauma are provided. Multi-component formulations of the invention comprise biologically active forms of any two, any three, or all four of at least one neurosteroid or neuroactive steroid, such as progesterone or synthetic progestin, at least one anti-epileptic or anticonvulsant, such as gabapentin, pregabalin or valproic acid, at least one NK-1 receptor antagonist, such as aprepitant, casopitant or vestipitant, at least one lithium-containing or lithium-related drug. The provided formulations are configured or adapted to prevent or reduce the incidence and severity of neurological damage caused by trauma, or the risk of such damage.

Abstract: The present invention relates to SHIP inhibitor compounds and methods for using these compounds. In particular, the present invention discloses the following methods: (i) a method of treating graft versus host disease in a subject; (ii) a method of inhibiting a SHIP1 protein in a cell; (iii) a method of selectively inhibiting a SHIP1 protein in a cell; (iv) a method for treating or preventing graft-versus-host disease (GVHD) in a recipient of an organ or tissue transplant; (v) a method of modulating SHIP activity in a cell expressing SHIP1 or SHIP2; (vi) a method of ex vivo or in vitro treatment of transplants; (vii) a method of inhibiting tumor growth and metastasis in a subject; (viii) a method of treating a hematologic malignancy in a subject; (ix) a method of inducing apoptosis of multiple myeloma cells; (x) a method of treating multiple myeloma in a subject; (xi) a method of inhibiting the proliferation of a human breast cancer cell; and (xii) a method of treating breast cancer in a subject.

Abstract: Provided herein is a method for reducing resistance in an individual having a drug resistant cancer, for example, a BRAF inhibitor resistant cancer. A Hippo signaling pathway inhibitor such as a Yes-associated protein 1 (YAP1) inhibitor, a Transcriptional Coactivator with PDZ-binding motif (TAZ) inhibitor, a Transcription enhancer domain (TEAD) inhibitor or a combination of these is administered. Also provided is a method of treating BRAF inhibitor resistance in an individual with a BRAF inhibitor resistant cancer, for example, malignant melanoma, with a Hippo signaling pathway inhibitor, such as Verteporfin, and a BRAF inhibitor.

Abstract: The present invention relates to the sialyltransferase ST3GAL6 for use as a biomarker for multiple myeloma, and especially as a marker for myelomas with inferior survival rates. The inventors have shown that glycosylation gene expression is dysregulated in Multiple Myeloma and that overexpression of the sialyltransferase ST3GAL6 is associated with inferior survival rates in patients.

Abstract: Pharmaceutical compositions having enhanced active component permeation properties are described.

Abstract: The present invention provides solid formulations of hyaluronic acid (HA) that are resistant to degradation into low molecular weight species of HA and yet can be readily dissolved in water. The compositions comprise sodium hyaluronate, cyclo-dextrin, sodium benzoate, and potassium sorbate, wherein said composition is in powder form.

Abstract: Pharmaceutical compositions having enhanced active component permeation properties are described.

Abstract: Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.

Abstract: The present application discloses 17? hydroxy steroid dehydrogenase (17? HSD) type 1, 3, 10 inhibitors and use thereof (alone and in combination) in the treatment of cancer and other afflictions. 17? HSD1 inhibitors include estradiol derivatives with a nieta-carbamoylbenzyl substituent at C 16. 17? HSD3/HSD10 inhibitors include androsterone derivatives substituted at the C3 position with a sulfonamide piperazine. Also disclosed are compounds that are inhibitors of both 17? HSD1 and 17? HSD3 that have a spiro-morpholine substituent at C20.

Abstract: This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurosteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.

Abstract: The present invention provides an externally applied composition capable of enhancing a stimulatory effect of an essential oil on IGF-1 secretion, the composition including (A) essential oil; and (B) at least one member selected from the group consisting of purine substances and salts thereof. Further, the present invention provides an externally applied composition capable of increasing the stratum corneum water content of the skin and maintaining transepidermal water loss at an appropriate level.

Abstract: The present disclosure relates to biomarkers of preterm birth, biomarkers of term birth, and methods of use thereof. In particular, the present disclosure provides methods of determining whether a pregnant woman is at an increased risk for premature delivery. The present disclosure further provides methods for decreasing a pregnant woman's risk for premature delivery.

Abstract: The disclosure relates to compounds and compositions for forming bone and methods related thereto. In one embodiment, the disclosure relates to a composition comprising a compound disclosed herein, such as 2,4-diamino-1,3,5-triazine derivatives or salts thereof, for use in bone growth processes. In a typical embodiment, a bone graft composition is implanted in a subject at a site of desired bone growth or enhancement.

Abstract: Methods of preventing and/or treating ischemia, organ dysfunction and/or organ failure, including multiple organ dysfunction syndrome (MODS), and necrosis and apoptosis associated with organ dysfunction/failure, are provided. For instance, the methods involve contacting organ(s) with an oxygenated cholesterol sulfate (OCS), e.g. 5-cholesten-3,25-diol, 3-sulfate (25H-C3S). The organ(s) may be in vivo (e.g. in a patient that is treated with the OCS) or ex vivo (e.g. an organ that has been harvested from a donor and is to be transplanted).

Abstract: This disclosure concerns novel demethylpenclomedine analogs. Also disclosed are pharmaceutical compositions and methods for using such compositions to treat hyperproliferative disorders.

Abstract: The invention relates to compounds of formula (I), to the pharmaceutical compositions comprising same, and to the use thereof in the treatment of bacterial, fungal, viral and parasitic infections or in the treatment of cancer in humans or animals. In formula (I), R1 and R2 are as defined in claim 1.

Abstract: The present invention relates to compositions, methods and kits for the treatment of respiratory disease. In particular, the compositions, methods and kits are particularly useful, but not limited to, the treatment or prevention of exacerbations of asthma and chronic obstructive pulmonary disease. The present invention provides a method of treating or preventing a respiratory disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of an inhibitor of casein kinase 1, thereby treating or preventing a respiratory disease in a subject. The present invention also provides a method of treating or preventing a respiratory disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of an inhibitor of ALK5, thereby treating or preventing a respiratory disease in a subject, wherein the inhibitor is administered directly to the airway and/or lungs.

Abstract: The present invention provides compounds of Formula (I), and pharmaceutically acceptable salts thereof, as well as pharmaceutical compositions comprising these compounds and methods of using these compounds to prevent or treat FXR-mediated or TGR5-mediated diseases or conditions.

Abstract: Disclosed are methods of treating or reducing the occurrence of a steatohepatitis disorder. The disorder may include, for example, NASH, parenteral nutrition associated liver disease (PNALD), or genetic forms of liver disease. The method may comprise the step of administering a composition comprising obeticholic acid to an individual in need thereof.

Abstract: A pharmaceutical two-phase admixture for topical application, transdermal or transmucosal, characterized by components in two phases, a liquid and a solid, adapted for topical application, transdermal or transmucosal, to various skin and/or mucosal surface areas of the body is disclosed. The solid phase is comprised of one or more bio-identical hormones and the liquid phase is comprised of one or more excipient carrier oils. The bio-identical hormone component is comprised of one or more of Bi-Est, testosterone, progesterone, and dehydroepiandrosterone. The excipient carrier oil component is comprised of one or more of jojoba oil, evening primrose oil, and borage seed oil. The pharmaceutical admixture is especially useful in a regime of hormone replacement therapy.

Abstract: The present patent application relates to a method of treating allergic rhinitis in a subject (preferably a human) by administering a combination of mometasone or its salt and olopatadine or its salt.

Abstract: The disclosure provides a method of treating a patient having postpartum depression, premenstrual dysphoric disorder, menopausal depression, or delirium tremens comprising administering an effective amount of an injectable neurosteroid formulation to the patient. In certain embodiments the injectable neurosteroid formulation is an injectable ganaxolone formulation. Two types of injectable neurosteroid formulations may be used in the disclosed methods. The first such formulation is an injectable formulation containing ganaxolone and sulfobutyl ether ?-cyclodextrin in a 1:1 inclusion complex. The second such formulation is an injectable neurosteroid formulation comprising a neurosteroid, preferably ganaxolone, but which may be a neurosteroid selected from allopregnanolone, ganaxolone, alphaxalone, alphadolone, hydroxydione, minaxolone, pregnanolone, tetrahydrocorticosterone, and combinations of the foregoing; a surface stabilizer selected from hydroxyl ethyl starch, dextran, and povidone; and a surfactant.

Abstract: Novel methods for prevention, reduction or elimination of the incidence of male androgen deficiency symptoms or diseases including male hypogonadism-associated symptoms and diseases associated with low serum testosterone and/or low DHEA or low total androgens in susceptible warm-blooded animals including humans involving administration of an amount of a sex steroid precursor, particularly dehydroepiandrosterone (DHEA) and a selective estrogen receptor modulator (SERM) (particularly acolbifene), an antiestrogen or a prodrug of the two.

Abstract: The invention provides a method for alleviating discogenic pain by administering a therapeutic agent that disrupts neuronal and/or vascular elements in the disc, which is typically a degenerated disc. Disruption of neuronal elements in the disk includes destroying nerve endings without substantially affecting the central body of the nerve, suppressing activation of the nerve endings, and inhibiting the growth of nerve endings into the disk. Disruption of vascular elements includes causing the vascular extensions to retract from the disk, or suppressing the formation of such extensions. The therapeutic agent may be administered locally via an interbody pump, a bolus or a depot, or may be administered systemically.

Abstract: Some embodiments of the present disclosure include a therapeutic extract for selectively treating skin disorders, such as acne and rosacea. The therapeutic extract may include glycerin; water, such as reverse osmosis water; blackcurrant; pine; gluconolactone; citric acid; and sodium benzoate. In embodiments, the blackcurrant may be organic ribes nigrum and may be derived from fruit of a blackcurrant plant. Moreover, the pine may be pinus spp and may be derived from a needle of a pine plant.

Abstract: The present invention is directed to a method of treating cervical intraepithelial neoplasia by administering a composition containing poly-gamma-glutamic acid. According to the present invention, cervical intraepithelial neoplasia in unmarried women, pre-childbirth women, or women who do not want infertility, can be treated without concern about infertility.

Abstract: Supplement formulations of estrogen blocker, glycogen manager, and muscle recovery solutions and sublingual therapies for increasing absorption rates thereof. The sublingual delivery systems allow the body to absorb up to 94.9% of each dose directly into the bloodstream, completely bypassing the digestion process. Sublingual delivery (under the tongue) results in potencies 4 to 5 times greater than most capsules and powders. An estrogen blocker solution includes purified water, vegetable glycerin, polypropylene glycol, potassium benzoate, citric acid, calcium D glucarate, 7 keto DHEA, IO3, DIM, nettle root extract, Agaricus biporus extract, narigin extract, and quercetin dehydrate. Formulas for glycogen manager, and muscle recovery are also disclosed.

Abstract: The present invention relates to the use of a combination of a PDE5-inhibitor and testosterone for the preparation of a medicament for the treatment of Female Sexual Dysfunction.

Abstract: Compounds having drug and bio-affecting properties, their pharmaceutical compositions and methods of use are set forth. In particular, betulinic acid derivatives that possess unique antiviral activity are provided as HIV maturation inhibitors, as represented by compounds of Formula I: These compounds are useful for the treatment of HIV and AIDS.

Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I): and pharmaceutically acceptable salts thereof; wherein , R1, R2, R3a, R3b, R4a, R4b, R5, R6, and R7 are as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, convulsive disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus.

Abstract: Disclosed are methods and compositions for treating or preventing a disease or disorder responsive to a decrease in baseline mitochondrial iron in a subject in need thereof. The methods typically include administering a pharmaceutical composition comprising a mitochondrial permeable iron chelator to the subject.

Abstract: Novel multi-component formulations, procedures and methods for use in treating neuropathology and neurodegeneration incident to trauma are provided. Multi-component formulations of the invention comprise biologically active forms of any two, any three, or all four of at least one neurosteroid or neuroactive steroid, such as progesterone or synthetic progestin, at least one anti-epileptic or anticonvulsant, such as gabapentin, pregabalin or valproic acid, at least one NK-1 receptor antagonist, such as aprepitant, casopitant or vestipitant, at least one lithium-containing or lithium-related drug. The provided formulations are configured or adapted to prevent or reduce the incidence and severity of neurological damage caused by trauma, or the risk of such damage.

Abstract: The present invention relates to a method of treating or preventing estrogen-sensitive tumours in a mammal, said method comprising the administration of a therapeutically effective amount of an estrogenic component to said mammal, wherein the estrogenic component is selected from the group consisting of: substances represented by the following formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and/or precursors. The estrogenic component according to the invention does not have undesirable proliferative effects on breast and/or endometrial tissue and displays sufficient estrogenicity to prevent that its administration will lead to hypoestrogenism and/or climacteric complaints.

Abstract: The invention relates to the use of a steroid-3-carboxylic acid ester, a steroid-4 carboxylic acid ester or a steroid-17 carboxylic acid ester of a steroid, selected from the group of androstanones, androst-4-ene-diones, androst-5-ene-diones, dehydroepiandrosterones, androstenetriones or testosterones, with an acyl group of the carboxylic acid ester where R is selected from alkyl with at least two carbon atoms or cycloalkyl, or with the use of a compound containing these steroid carboxylic acid esters for local topical application for cosmetic or dermatological purposes. Moreover, this invention also relates to steroid carboxylic acid esters and their compounds used for local topical application.

Abstract: This invention is directed to methods of preparing AQX-1125 having the formula: This invention is also directed to intermediates utilized in the methods of preparing AQX-1125.

Abstract: Personal lubricants containing royal jelly, a glow powder or xylitol are provided.

Abstract: Disclosed is a pharmaceutical composition for antifungal use, comprising: 1) one or more compounds selected from compounds represented by the general formula (1) below and physiologically acceptable salts thereof; 2) one or more compounds selected from polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol; and 3) one or more compounds selected from glucono-?-lactone, propylene glycol, glycerin, and lactic acid. General formula (1) (In the formula, X represents a halogen or hydrogen). wherein X represents a halogen or hydrogen.

Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Cationic steroidal antimicrobials (“CSAs” or “ceragenins”) and methods of making and using the same. Particularly advantageous uses include treating infections in patient and sub-patient populations, especially those having a bone disease, a broken bone, a bone infection, or a bone implant.

Abstract: This disclosure concerns novel demethylpenclomedine analogs. Also disclosed are pharmaceutical compositions and methods for using such compositions to treat hyperproliferative disorders.

Abstract: The invention relates to a pharmaceutical tablet for oral administration comprising ulipristal acetate together with the following excipients: at least one diluent in an amount of 50 to 98.5 wt %, at least one binding agent in an amount of 0 to 10 wt %, at least one disintegrating agent in an amount of 0.5 to 10 wt %, and at least one lubricant in an amount of 0 to 10 wt %.

Abstract: The invention relates to the use of ulipristal acetate, or any of its metabolites, in preventing or treating a breast tumor in a patient, preferably a patient that carries a mutation in BRCA1 gene.

Abstract: The invention relates to the field of female sexual dysfunction. It specifically relates to the influence of the combination of testosterone or an analog thereof and tadalafil on sexual health in female subjects with Female Sexual Dysfunction (such as Female Sexual Arousal Disorder (FSAD) or Female Sexual Desire Disorder (FSDD)). It further relates to the influence of the combination of testosterone or an analog thereof and a compound capable of at least in part inhibiting smooth muscle constriction, for example a compound capable of at least in part inhibiting the adrenergic tone. The invention further discloses other combinatorial therapies in the treatment of Female Sexual Dysfunction.