Abstract: The invention provides a method for treatment of primary progesterone receptor-negative (PR?) endometrial cancer comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a progesterone receptor (PR) agonist. The invention further provides a method for treatment of a primary estrogen receptor-negative (ER?) breast cancer, comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a selective estrogen receptor modulator (SERM) or a selective estrogen receptor down-regulator (SERD). Also provided are compositions related to the above methods.

Abstract: The present invention addresses methods and uses of quinoline derivatives in the treatment of tumours and pharmaceutical compositions for treatment of same. Specifically, the present invention involves a method and applications for the use of the quinoline derivative 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropylamine in the treatment of soft tissue sarcomas and pharmaceutical compositions for treatment of same.

Abstract: Methods of selectively inhibiting Akt3 are provided. It has been discovered that 4-[(6-nitroquinolin-4-yl)amino]-N-[4-(pyridin-4-ylamino)phenyl]benzamide selectively inhibits Akt3. Because Akt3 modulates the suppressive function of natural Tregs and the polarization of induced Tregs, 4-[(6-nitroquinolin-4-yl)amino]-N-[4-(pyridin-4-ylamino)phenyl]benzamide can be used for modulating immune responses.

Abstract: The present invention relates to a transdermal patch comprising oxymorphone. The present invention also relates to processes for the preparation of the transdermal patches defined herein, as well as to the use of these patches for the treatment of pain.

Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product.

Abstract: Presented herein are methods for preventing or treating tumor growth, tumor metastasis and/or abnormal proliferation of tumor cells in a subject, wherein the methods involve administration of a pharmaceutical composition comprising methylnaltrexone. Also presented herein are methods for inhibiting or slowing the growth of a tumor in a subject, wherein the methods include selecting a subject who is a suitable candidate for treatment with methylnaltrexone, and administering a composition comprising methylnaltrexone to the subject.

Abstract: Provided are an oral formulation capable of improving easy administrability and showing good preservation stability, and a substrate for oral formulation. An oral formulation containing a medicament; sugar alcohol; one or more kinds of hydrophilic polysaccharides selected from the group consisting of acacia, pullulan and maltodextrin; a gelling agent; and water, and a substrate for oral formulation, which contains sugar alcohol; the above-mentioned hydrophilic polysaccharides; a gelling agent; and water.

Abstract: This application discloses a composition comprising an amiloride and/or an amiloride analog which can be used for reducing nerve injury or nervous system injury in a subject. The formulation of such composition is also disclosed. The application further directs to methods for treating nerve injury or nervous system injury by administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising amiloride, an amiloride analog or a pharmaceutically acceptable salt thereof.

Abstract: Osmolyte-containing preparations are provided for the local treatment of dry mucous membranes by enhancing mucus production. Included are the use of osmolytes for the production of a medicament, medical product or cosmetic product for the prevention, therapy and/or care of dry mucous membranes. Topical preparations based on osmolytes to which sodium chloride and/or moisturizers can optionally be added. The group of osmolytes embraces various low-molecular substances, in particular ectoine, homoectoine, hydroxyectoine, di-myo-inositol phosphate (DIP), cyclic 2,3-diphosphoglycerate (cDPG), 1,1-di-glycerol phosphate (DGP), ?-mannosylglycerate (Firoin), ?-mannosylglyceramide (Firoin-A), di-mannosyl di-inositol phosphate (DMIP), glucosylglycerol and/or a derivative, e.g., an acid, salt or ester, of these compounds.

Abstract: The present invention is directed to benzamide-containing compounds of formula I or pharmaceutically acceptable salts thereof which inhibit the P2X7 receptor, and their use in the treatment of epilepsy.

Abstract: This invention relates to solid oral pharmaceutical formulations or(S)-methyl ((4(4-(3-(5-chtoro-2-fluoro-3-(methyl-sutfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.

Abstract: This invention relates to an immunomodulator comprising, as an active ingredient, (S)—N-(4-amino-5-(quinolin-3-yl)-6,7,8,9-tetrahydropyrimido[5,4-b]indolizin-8-yl)acrylamide represented by Formula (I) or a salt thereof and a pharmaceutical composition for the prevention or treatment of a disease that can be ameliorated via immunomodulation.

Abstract: There is provided a hemihydrate form of the sodium salt of pemirolast.

Abstract: A liposome-encapsulated formulation of irinotecan can be used for the treatment of pancreatic cancer in combination with 5-fluorouracil and leucovorin, including treatment of patients diagnosed with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine.

Abstract: The present invention relates to the compound of formula (I) and to compositions comprising the same and to the use of the compound and to compositions of the compound in treatment, for example in the treatment of inflammatory diseases, in particular respiratory inflammatory disease. The invention also extends to methods of making the said compound.

Abstract: The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of debrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).

Abstract: The present invention relates to a pediatric powder for reconstitution as suspension for oral administration comprising a therapeutically effective amount of an antiviral agent or pharmaceutical acceptable salt or derivative thereof, in particular Valaciclovir in complex with an ion exchange resin in a specific ratio in order to obtain a palatable and child-friendly product. It also relates to a process for the preparation thereof.

Abstract: The present invention relates to a pediatric chewable tablet comprising a therapeutically effective amount of an anti-viral agent or pharmaceutical acceptable salt or derivative thereof, in particular Valaciclovir in complex with an ion exchange resin in a specific ratio in order to obtain a palatable and child-friendly product. It also relates to a process for the preparation thereof.

Abstract: Provided is a prophylactic or therapeutic agent for a posterior ocular disease, which comprises a compound represented by formula (1) below: its enantiomer or diastereomer, or a pharmaceutically acceptable salt thereof as an active ingredient.

Abstract: Provided herein are compounds according to Formula I and pharmaceutically acceptable salts thereof, and compositions comprising the same, for use in various methods, including treating cancers such as colon, ovarian, pancreatic, breast, liver, prostate and hematologic cancers:

Abstract: The present invention is directed to methods of treating a tumor, in particular human tumors, including administering an effective amount of a MER tyrosine kinase inhibitor (MER TKI) to inhibit TKI signaling in a tumor. The use of a MER TKI in combination with a chemotherapeutic agent, wherein the MER TKI can be administered to a host with a cancer prior to, during, or after administration with a chemotherapeutic agent, provides for increased anti-tumor effects without an increase in the standard of care dosage of the chemotherapeutic agent.

Abstract: A novel nanoparticle drug composition and method of use thereof is presented herein. The nanoparticle drug composition is comprised of at least one nanoparticle carrier, formed from the conjugation of PLGA and. PEG, which encapsulates a drug such as afobazole and its derivatives, in a pharmaceutically acceptable carrier. The nanoparticle drug composition may be used to treat various diseases of the central nervous system involving excessive neuronal activity and inflammation such as stroke, Alzheimer's disease and anxiety.

Abstract: The invention relates to 1,2,4-thiadiazole derivatives and their use to treat parasites.

Abstract: Provided herein are ophthalmic pharmaceutical formulations comprising a rifamycin compound. Also provided herein are methods of treating ocular diseases or disorders by administering such ophthalmic formulations. This invention relates generally to pharmaceutical compositions or formulations suitable for administration to an eye. In some aspects, this invention relates to ophthalmic pharmaceutical compositions or formulations comprising one or more rifamycin compounds selected from the group consisting of rifampicin, rifabutin, rifapentine. In one aspect, the invention relates to methods of treating an ocular disease, disorder or condition comprising administering to a patient in need thereof an ophthalmic composition comprising an effective amount of a rifamycin compound selected from the group consisting of rifampicin, rifabutin, rifapentine, and rifaximin.

Abstract: Compounds of formula (I): wherein A1, A2, Ra, Rb, Rc, Rd, R3, R4, R5 and T are as defined in the description. Medicinal products containing the same which are useful in treating pathologies involving a deficit in apoptosis, such as cancer, auto-immune diseases, and diseases of the immune system.

Abstract: Described herein is a novel dosage regimen, and related uses and methods, for a prostaglandin FP receptor agonist (PFPRA) compound topically administered to the skin. The dosage regimen is useful for reduction of subcutaneous fat, for example, in patients who suffer from local excesses of subcutaneous fat. A particular advantage of the dosage regimen is the ability to reduce composition exposure and thereby promote convenience and comfort, while maintaining the desired exposure and therapeutic effect in subcutaneous fat. Further provided are kits according to the novel dosage regimen, comprising a PFPRA composition and instruction for use.

Abstract: A method of decreasing intraocular pressure (IOP) in an eye of a patient in need thereof includes implanting a first lacrimal implant through a firsts punctum and into a first lacrimal canaliculus of the eye of the patient. The method may further comprise implanting a second lacrimal implant through a second punctum and into a second lacrimal canaliculus of the eye of the patient, and releasing, on a sustained basis a therapeutically effective amount of an intraocular pressure-reducing therapeutic agent.

Abstract: The invention provides a method for treatment of primary progesterone receptor-negative (PR?) endometrial cancer comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a progesterone receptor (PR) agonist. The invention further provides a method for treatment of a primary estrogen receptor-negative (ER?) breast cancer, comprising administering (i) cridanimod or a salt or an ester thereof and (ii) a selective estrogen receptor modulator (SERM) or a selective estrogen receptor down-regulator (SERD). Also provided are compositions related to the above methods.

Abstract: In certain embodiments, the invention is directed to composition comprising stable particles comprising ganaxolone, wherein the volume weighted median diameter (D50) of the particles is from about 50 nm to about 500 nm.

Abstract: The disclosure relates to the treatment of adrenal insufficiency with particular but not limiting application to paediatric treatment regimens, the treatment of the elderly and non-human animals.

Abstract: The invention relates to 17-hydroxy-17-pentafluoroethyl-estra-4,9(10)-dien-11-aryl derivatives of Formula I with progesterone antagonizing action and method of production thereof, use thereof for the treatment and/or prophylaxis of diseases and use thereof for the production of medicinal products for the treatment and/or prophylaxis of diseases, in particular of fibroids of the uterus (myomas, uterine leiomyoma), endometriosis, heavy menstrual bleeds, meningiomas, hormone-dependent breast cancers and complaints associated with the menopause or for fertility control and emergency contraception.

Abstract: This invention provides a combination product comprising an inhalable long-acting muscarinic antagonist (LAMA) composition for use in the long-term treatment of COPD combined with an inhalable fixed-dose composition comprising budesonide and formoterol or a pharmaceutically acceptable salt thereof for administration pro re nata (prn) as a rescue medication for the treatment of acute exacerbations of COPD.

Abstract: This invention relates to a low cost rapid response diagnostic system to determine cortisol levels in patients selected as potential candidates for GCR (glucocorticoid receptor) antagonist therapy utilizing a GCR antagonist, such as ORG 34517. The rapid, sensitive, and inexpensive test can be used to determine patients who have non-normal cortisol production or disordered circadian rhythms as a method for selecting subjects for GCR antagonist therapy for whom it is likely to have beneficial and/or therapeutic effects, and can also be used to monitor changes in cortisol levels in response to treatment.

Abstract: The invention is directed to compositions of vitamin D having enhanced bioavailability and enhanced stability. Methods of making and using the compositions of the invention are contemplated and disclosed.

Abstract: Device and method for improving the effectiveness of osteopathic pain therapy by monitoring one or more pharmacokinetic parameters of the subject with a point-of-care device after pain drug administration. In one embodiment, the pain drug is celecoxib and the pharmacokinetic parameter is AUC.

Abstract: There is disclosed herein a composition for treating extracellular parasitic infections, the composition comprising one or more of the following combinations: at least one quinolone or fluoroquinolone together with at least one tetracycline, iodoquinol, an azole or imidazole; or at least two agents selected from the group consisting of iodoquinol, thiazolidones, tetracycline, nitroimidazoles, cotrimoxazole and diloxanide furoate.

Abstract: The present invention relates to pharmaceutical compositions comprising a phosphonic acid compound, such as a natural product. Such compounds can include, such as an antibiotic or compound with other activity, derived from an Actinobacteria strain having a gene encoding pepM (phosphoenolpyruvate phosphomutase) or a pepM-dependent biosynthetic pathway. The present invention also relates to methods for treating or preventing or reducing the risk of a bacterial infection by administering a therapeutically effective or prophylactically effective amount of a phosphonic acid antibiotic, or a pharmaceutical composition containing such an antibiotic, to a patient or subject in need thereof. The present invention further relates to methods for isolating, purfying, and identifying such phosphonic acid compounds from Actinobacteria strains.

Abstract: Disclosed herein are nutrient delivery systems comprising a pod and a nutritional powder comprising a human milk oligosaccharide or a precursor thereof.

Abstract: Disclosed are pharmaceutical compositions having an effective amount of substantially amorphous ledipasvir and an effective amount of substantially crystalline sofosbuvir.

Abstract: Disclosed is a method of promoting wound healing or wound closure. The method comprises administration of a miR-198 inhibitor and/or a follistatin-like-1 (FSTL1) polypeptide. Also disclosed are method of treating chronic cutaneous wounds, method of identifying a non-healing wound, use and a pharmaceutical composition comprising a miR-198 inhibitor and/or a follistatin-like-1 (FSTL1) polypeptide.

Abstract: The presently disclosed subject matter relates to methods of inhibiting cancer stem cells and growth of aggressive and/or poorly differentiated metastatic tumors comprising the cancer stem cells with HMGA1 inhibitors. The presently disclosed subject matter also provides methods of selecting and treating a subject with aggressive and/or poorly differentiated metastatic cancer using HMGA1 inhibitors.

Abstract: The present invention relates to compositions that may be swallowable, chewable or dissolvable, comprising various vitamins and minerals, and in a specific embodiment comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D3, vitamin E, iron, magnesium and zinc, and methods for using these compositions for nutritional supplementation in subjects undergoing physiologically stressful events, such as, for example and without limitation, pregnancy, lactation or any disease state.

Abstract: The application describes compositions that include maltosyl-isomalto-oligosaccharides with a desirable mass average molecular weight distribution. In some cases, the compositions can contain at least 3% mannitol.

Abstract: Aspects of the invention provide compositions for use in the treatment galectin-dependent diseases. In particular, compositions comprising a selectively depolymerized, branched galactoarabino-rhamnogalacturonate whose backbone is predominantly comprised of 1,4-linked galacturonic acid (GalA) moieties, with a lesser backbone composition of alternating 1,4-linked GalA and 1,2-linked rhamnose (Rha), which in-turn is linked to any number of side chains, including predominantly 1,4-b-D-galactose (Gal) and 1,5-a-L-arabinose (Ara) residues.

Abstract: Provided are a temperature sensitive adhesion prevention composition and a method for producing the same, the composition comprising a polyethylene oxide (PEO) containing copolymer, a carboxy polysaccharide, and a monovalent cation.

Abstract: The present invention provides a tablet core which comprises at least about 95% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 95% by weight of an aliphatic amine polymer resin The method comprises the step of compressing the aliphatic amine polymer to form the tablet core. The tablet core can further include one or more excipients. In this embodiment, the method of producing the tablet core comprises the steps of: (1) hydrating the aliphatic amine polymer to the desired moisture level; (2) blending the aliphatic amine polymer with the excipients in amounts such that the polymer comprises at least about 95% by weight of the resulting blend; and (3) compressing the blend to form the tablet core. The present invention further relates to a coated tablet comprising an aliphatic amine polymer core wherein the coating is a water based coating.

Abstract: Systems and methods are disclosed for generating a gas at therapeutic levels to a subject by providing a pellet dispenser that delivers a predetermined amount of thermally labile compound to a furnace; controlling a rate of compound addition to allow controlled continuous evolution of the gas; and maintaining a predetermined concentration of the gas using temperature and dilution with an inert gas.

Abstract: Multivalent scaffolds configured to facilitate drug release upon exposure to a stimulus, such as heat, or light, are described herein. The multivalent scaffolds are covalently bound to a moiety that is susceptible to decomposition upon exposure to stimulus. The moiety releases HNO upon decomposition. In some embodiments, the moiety is in turn linked to an agent to be delivered, such as a therapeutic agent, which is released from the multivalent scaffolds when the moiety decomposes. In some embodiments, the moiety is a 1,2-oxazine moiety. In some embodiments, the multivalent scaffold is a polymer. A plurality of 1,2-oxazine moieties can be covalently bound as side chains to the backbone of the polymer.

Abstract: The present invention provides, among other things, compositions and methods suitable for the treatment of hyperphosphatemia based on phosphate-binding magnesium salts. In some embodiments, the present invention provides compositions and methods suitable for the treatment of hyperphosphatemia based on the combination of phosphate-binding magnesium and calcium salts.

Abstract: Aqueous anti-microbial and cosmetic compositions are provided that comprise chlorine dioxide, wherein the chlorine dioxide is stabilized by two quaternary ammonium cations (“quats”). These quat-stabilized chlorine dioxide compositions can also comprise a dye, a surfactant or surfactant blend, a thickener, a foam booster and/or a fragrance. The quat-stabilized chlorine dioxide compositions can be used for sanitizing and conditioning the skin of humans and animals.