Abstract: A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a disintegrant, a surfactant, a binder, and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Processes of preparing pharmaceutical compositions comprising Compound 1 are also disclosed.

Abstract: An oral solid dosage form comprising a mixture of compound of formula I and a fusible polymeric carrier; and optionally pharmaceutically acceptable excipients, wherein the mixture is an amorphous dispersion.

Abstract: The present invention relates generally to abuse-deterrent formulations containing dextroamphetamine sulfate.

Abstract: The invention relates to microparticles comprising a crosslinked gel and methods for making and using same.

Abstract: The present invention relates to a pharmaceutical composition comprising Levetiracetam, Brivaracetam or Seletracetam as active ingredient, the invention relates specifically to a prolonged release formulation.

Abstract: A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, glycolide polymer or a lactide-glycolide copolymer hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam and a method of preparing said sterile pharmaceutical dosage form.

Abstract: Non-liposome, non-micelle particles formed of a lipid, an additional adjuvant such as a TLR4 agonist, a sterol, and a saponin are provided. The particles are porous, cage-like nanoparticles, also referred to as nanocages, and are typically between about 30 nm and about 60 nm. In some embodiments, the nanocages include or are administered in combination with an antigen. The particles can increase immune responses and are particularly useful as adjuvants in vaccine applications and related methods of treatment. Preferred lipids, additional adjuvants including TLR4 agonists, sterols, and saponins, methods of making the nanocages, and method of using them are also provided.

Abstract: Provided herein are nanoalum particles comprising an aluminum salt and a sizing agent, wherein the size of the particle N ranges from about 1 nm to 450 nm. Such nanoalum particles are stable and are amenable to a terminal sterilization step prior to vialing. Compositions comprising the nanoalum particles, and the making and using of the nanoalum particles are also provided.

Abstract: Nanoparticulate pharmaceutical formulations and methods for co-delivery of two or more species of nucleic acids for simultaneous suppression and expression of target genes in a cell, are provided. The nanoparticles encapsulate two or more nucleic acid species. The first nucleic acid suppresses expression of a gene or product thereof, e.g., inhibitory nucleic acid, such as antisense, siRNA, miRNA, Dicer siRNA, piRNA, etc. The second nucleic acid increases expression of, or encodes, an endogenous or exogenous protein or polypeptide, e.g., an mRNA. The first and second nucleic acid species simultaneously target or affect the same or different cellular processes within a cell including communication, senescence, DNA repair, gene expression, metabolism, necrosis, and apoptosis.

Abstract: The present invention relates to a transdermal therapeutic system (TTS) for the transdermal administration of asenapine comprising a self-adhesive layer structure comprising a therapeutically effective amount of asenapine, said self-adhesive layer structure comprising: A) a backing layer; B) an asenapine-containing layer comprising: 1. asenapine in the form of the free base; and 2. a polymer selected from the group consisting of polysiloxanes and polyisobutylenes in an amount of more than 50% by weight based on the total weight of the asenapine-containing layer; and C) optionally an additional skin contact layer.

Abstract: A transdermal patch including: a) a membrane of a flexible polymeric material acting as a support layer, forming the outer cover of the patch, to which the following element is adhered using a copolymer adhesive; b) a layer of non-woven fabric (or TNT) including: i) Aminoacids L-Leucine, L-Isoleucine and L-Valine, and vitamins B1 and B5 as active ingredients; or their chemically acceptable salts or byproducts; ii) excipients selected from modulators for the release of active ingredients, optimisers for the absorption of active agents, solvents, surfactants and emulsifiers; and c) a transparent removable plastic film covering the above elements and the adhesive cord from environmental conditions. The film must be removed by the athlete before adhering the patch to his skin.

Abstract: Technologies are described for delivery of compounds to aid in weight management. A transdermal microdispenser based system may deliver weight management compounds through the time and dose specific administration of appetite suppression, metabolic enhancers, and satiation compounds. The transdermal delivery system may be controlled based on data associated with subject such as calorie intake, physical activity, satiation, and hunger. The system may be integrated with medical monitoring or fitness tracking systems. Delivery of the compounds may be distributed over the course of a day at selected or adjusted doses to be safe and effective for their specific modality. For example, appetite suppressants may be delivered during periods of the day when cravings occur, satiation compounds may be delivered to coincide with meals, and metabolic stimulators may be delivered at times to optimally increase metabolism based on caloric balance. Control factors may also be predictive to prevent the onset of hunger.

Abstract: A nutritional composition including no greater than about 7 g/100 kcal of a fat or lipid source; no greater than about 7 g/100 kcal of a protein or protein equivalent source; at least about 5 g/100 kcal of a carbohydrate; and at least about 9 mg/100 kcal of inositol, wherein the inositol comprises exogenous inositol and inherent inositol, and wherein the ratio of exogenous inositol to inherent inositol is at least 75:25.

Abstract: Described herein, inter alia, are compositions, formulations, methods, and systems for reducing regional fat deposits and treating fat-related conditions.

Abstract: In some aspects, the disclosure relates to RNAi constructs with improved tissue and cellular uptake characteristics and methods of use of these compounds in dermal applications.

Abstract: The present disclosure provides methods of mimicking epinephrine plasma pharmacokinetic parameters/plasma epinephrine levels of an at least one l-epinephrine injection in humans with an at least one dosage of an intranasal and/or sublingual l-epinephrine formulation. Methods of maintaining constant elevated plasma epinephrine level(s) by the consecutive dosing of intranasal and/or sublingual l-epinephrine are also provided. These methods may be helpful when l-epinephrine injection is not available or not possible. The present disclosure allows formulations for intranasal administration of l-epinephrine and/or small, l-epinephrine sublingual tablets to be conveniently carried by soldiers and others, such as in a remote location or battlefield, and such as when emergency medical services are not readily available or accessible. The methods may be able to sustain life and restore proper blood perfusion when someone is having cardiopulmonary difficulty until medical help or transport can arrive.

Abstract: The invention is directed to methods and compositions of stabilizing phenylephrine formations. The composition has good time-dependent stability at low temperature and has no change in its outward appearance even after having been stored at least 6 months.

Abstract: Methods for inhibiting transepithelial ion transport, inhibiting hydrocephalic development, and for treating hydrocephalus are disclosed herein. The methods include administering a potassium channel inhibitor to the individual. In one particular embodiment, the individual is administered the calcium-activated potassium channel inhibitor, fluoxetine.

Abstract: This invention provides: 1) a method of treating androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 2) a method of preventing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 3) a method of suppressing or inhibiting androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/ or hot flashes in a male subject suffering from prostate cancer; and 4) a method of reducing the risk of developing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/ or hot flashes in a male subject suffering from prostate cancer, by administering to the subject a pharmaceutical composition comprising cis-clomiphene or a pharmaceutically acceptable salt thereof.

Abstract: The present invention relates to pharmaceutical compositions comprising safinamide, and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles and a process for preparing them.

Abstract: The present disclosure provides an external preparation comprising lactic acid salt of lidocaine and diclofenac or a salt thereof, wherein lactic acid salt of lidocaine is contained in an amount of 2-5 moles per mole of diclofenac or a salt thereof, which exhibits the improved transdermal absorbability of lidocaine and diclofenac which are active ingredients as well as the skin permeability suitable for clinical use.

Abstract: This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.

Abstract: The present disclosure relates to a method of preventing and/or treating non-alcoholic steatohepatitis in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a compound of Formula (II): wherein R1, R2, R3, X and Y are as defined in the specification; or a pharmaceutically acceptable salt, solvate, or solvate of such a salt. More particularly, the present disclosure relates to a method of preventing and/or treating non-alcoholic steatohepatitis in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a compound of Formula (I): wherein R2, R3, and X, are as defined in the specification; or a pharmaceutically acceptable salt, solvate, or solvate of such a salt.

Abstract: The present patent application relates to novel polyunsaturated fatty acid salt (PUFA salts) solid formulations.

Abstract: Compositions of a polyunsaturated omega-3 fatty acid such as (5Z,8Z,11Z,14Z,17Z)-eicosa-5,8,11,14,17-pentaenoic acid (EPA) and (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid (DHA) for preventing and/or treating cachexia in a subject are disclosed. The compositions contain a certain amount of the fatty acids as monoacylglycerides. Further, a method of preventing and/or treating cachexia in a subject is disclosed, including administering a composition of EPA and DHA to the subject, wherein at least a part of the fatty acids are provided in monoacylglyceride form.

Abstract: The present application relates to pharmaceutical compositions comprising retinoic acid or its derivatives such as isotretinoin and processes for preparing thereof. It also provides methods for treating acne by administering such pharmaceutical composition to a patient in need thereof.

Abstract: Provided herein are methods of preventing or treating cardiovascular disease (CVD), methods of supporting cardiovascular health, or supporting inflammatory health in a subject by reducing C-reactive protein (CRP). In exemplary aspects, the method comprises administering astaxanthin to the subject at a therapeutically effective amount. In some aspects, the subject also receives a standard of care for CVD or risk management thereof. The present disclosure also provides methods of reducing CRP levels in a subject comprising administering an amount of astaxanthin to the subject, as described herein, wherein the subject is at risk for or suffers from CVD. Additional related methods of altering levels of one or more of: TNF-?, IL-1?, IL-6, INF-?, oxidized LDL, total cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides, FOXO3 activation, and HDL cholesterol, comprising administering astaxanthin to the subject are further provided herein.

Abstract: The present patent application relates to solid particles comprising vitamin A and/or its derivatives, which are more stable when compressed into tablets.

Abstract: Provided is an agent for promoting degradation and clearance of amyloid-?, the agent allowing continuous ingestion with high safety. The agent for promoting degradation and clearance of amyloid-? comprises a chlorogenic acid or a salt thereof as an active ingredient.

Abstract: The present invention provides compounds for use in the treatment of respiratory diseases of animals, especially Bovine or Swine Respiratory disease (BRD and SRD).

Abstract: The present invention provides a pharmaceutical composition for oral administration, consisting essentially of (a) 4 to 40% by weight of a taxane, (b) 10 to 40% by weight of polyoxyl glyceryl fatty acid ester, (c) 30 to 70% by weight of monooleoyl glycerol or 30 to 70% by weight of an oleoyl glycerol complex having 30 to 65% by weight of monooleoyl glycerol contents; 15 to 50% by weight of dioleoyl glycerol contents; and 2 to 20% by weight of trioleoyl glycerol contents, and (d) 5 to 30% by weight of a surfactant and a process for preparing the same.

Abstract: The present invention relates to methods for treating brain metastasis by inhibiting gap junction functionality. It is based, at least in part, on the discovery that cancer cells expressing Protocadherin 7 and Connexin 43 form gap junctions with astrocytes that promote the growth of brain metastases, and that inhibition of Protocadherin 7 and/or Connexin 43 expression in cancer cells reduce progression of brain metastases. It is further based on the discovery that treatment with gap junction inhibitors tonabersat and meclofenamate inhibited progression of brain metastatic lesions and enhanced the anti-cancer activity of the conventional chemotherapeutic agent, carboplatin.

Abstract: Disclosed herein are methods and compounds of augmenting and enhancing the production of type I IFNs in vivo. In some embodiments, also disclosed herein include methods of activating and enhancing the cGAS-STING response and use of an immunogenic cell death inducer with an inhibitor of a phosphodiesterase for the treatment of cancer.

Abstract: A pharmaceutical composition intended for use in the prevention and/or treatment of leukaemia in a subject, the composition includes palytoxin (PLTX) and a pharmaceutically acceptable carrier. The application also relates to other medical uses of palytoxin and a method for its extraction from Palythoa clavata polyps. A method for isolating the symbiodinium dinoflagellate from Palythoa clavata is also described.

Abstract: The invention provides a method for treating fibrosis, nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) in an animal, comprising administering to the animal, a compound of formula I: or a pharmaceutically acceptable salt thereof.

Abstract: Aspects of the present disclosure include antibacterial aromatic sulfonyl fluoride agents. The subject aromatic sulfonyl fluoride agents have a pharmacophore that can provide for potent antibacterial activity. The subject agents are compounds including an aromatic group substituted with a sulfonyl fluoride warhead group and an electron withdrawing group. The subject agents find use in a variety of antibiotic applications. In some cases, the subject agents find use in methods of treating bacterial infections in a subject. Also provided are pharmaceutical compositions and kits that find use in practicing the subject methods.

Abstract: Provided herein are compounds of formula (I)-(VI): wherein the variables are defined herein, processes of making them, and methods of treating cancer comprising administering such compounds.

Abstract: An object of the present invention is to provide an excellent drug for preventing or treating spinocerebellar ataxia. 1-(3-(2-(1-benzothiophen-5-yl)ethoxy)propyl)azetidin-3-ol or a salt thereof has an effect of suppressing brain atrophy, especially cerebellar atrophy, and is useful as an agent for preventing or treating spinocerebellar ataxia. Cerebellar atrophy observed in spinocerebellar ataxia can be prevented or treated by administering 1-(3-(2-(1-benzothiophen-5-yl)ethoxy)propyl)azetidin-3-ol or a salt thereof.

Abstract: There is provided a new dosage regimen for Compound A which maximizes anti-tumor activity while maintaining acceptable toxicity levels.

Abstract: The present disclosure is related to dosage strategies for the treatment of CNS cancers with proteasome inhibitors (e.g., marizomib). For instance, the disclosure is related to strategies in which a proteasome inhibitor (e.g., marizomib) is administered at the same or higher dosage even after a subject has experienced a CNS-related adverse event.

Abstract: The present invention relates to combinations and methods for the treatment of neurological disorders related to glutamate excitotoxicity and Amyloid ? toxicity. More specifically, the present invention relates to novel combinatorial therapies of Alzheimer's disease, Alzheimer's disease related disorders, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Huntington's disease, neuropathic pain, alcoholic neuropathy, alcoholism or alcohol withdrawal, or spinal cord injury, based on baclofen and acamprosate combination.

Abstract: The present invention covers [(phenylsulfonyl)octahydro-epiminoisoindol-yl](1H-1,2,3-triazol-5-yl)methanone compounds of general formula (I), in which Q, R1, R2, R3, R4 and R5 are as defined herein, methods of preparing said compounds, intermediate compounds useful for preparing said compounds, pharmaceutical compositions and combinations comprising said compounds and the use of said compounds for manufacturing pharmaceutical compositions for the treatment or prophylaxis of disorders, in particular of gynecological disorders, hyperproliferative disorders, metabolic disorders, or inflammatory disorders as a sole agent or in combination with other active ingredients.

Abstract: Formulations comprising cycloserine compounds and one or more enteric materials in a solid dosage form, and uses thereof for treating and/or reducing the risk of a neuropsychiatric disorder or tuberculosis.

Abstract: The present disclosure relates to bifunctional compounds, which find utility as modulators of ?-synuclein (target protein). In particular, the present disclosure is directed to bifunctional compounds, which contain on one end a Von Hippel-Lindau, cereblon. Inhibitors of Apotosis Proteins or mouse double-minute homolog 2 ligand which binds to the respective E3 ubiquitin ligase and on the other end a moiety which binds the target protein, such that the target protein is placed in proximity to the ubiquitin ligase to effect degradation (and inhibition) of target protein. The present disclosure exhibits a broad range of pharmacological activities associated with degradation/inhibition of target protein. Diseases or disorders that result from aggregation or accumulation of the target protein are treated or prevented with compounds and compositions of the present disclosure.

Abstract: Pharmaceutical compositions of the invention include substituted riluzole prodrugs useful for the treatment of cancers including melanoma, breast cancer, brain cancer, and prostate cancer through the release of riluzole. Prodrugs of riluzole have enhanced stability to hepatic metabolism and are delivered into systemic circulation by oral administration, and then cleaved to release riluzole in the plasma via either an enzymatic or general biophysical release process.

Abstract: Methods of treating conditions for which S1P-mediated neuroprotection is medically indicated, comprising administering to a subject in need thereof an agonist of the sphingosine 1-phosphate receptor (S1P receptor); such as a compound having the following structure (See Formula 1): or a pharmaceutically acceptable salt, stereoisomer, homolog, hydrate or solvate thereof.

Abstract: This disclosure relates to methods of treating or preventing cystic fibrosis transmembrane conductance regulator (CFTR) mediated diseases such as cystic fibrosis, chronic obstructive pulmonary disease, chronic pancreatitis, chronic bronchitis, asthma, mucus formation, comprising administering an effective amount of a 3-(phenyl)-N-(4-phenoxybenzyl)-1,2,4-oxadiazole-5-carboxamide compound, salt, or derivative thereof to a subject in need thereof. In certain embodiments, the 2-amino-N?-benzylidene-acetohydrazide compound is 3-(3,5-dibromo-4-hydroxyphenyl)-N-(4-phenoxybenzyl)-1,2,4-oxadiazole-5-carboxamide.

Abstract: The present disclosure provides compositions and methods for reactivating latent immunodeficiency virus using a glycogen synthase kinase 3? inhibitor, such as a glycogen synthase kinase 3? (GSK-3?) or a glycogen synthase kinase 3? (GSK-3?) inhibitor. In some embodiments, the glycogen synthase kinase 3 inhibitor is a glycogen synthase kinase antagonist, e.g., Tideglusib (4-benzyl-2-(naphthalen-1-yl)-1,2,4-thiadiazolidine-3,5-dione), or a pharmaceutically acceptable salt or derivative thereof. In other embodiments, the glycogen synthase kinase 3 inhibitor is a maleimide-based glycogen synthase kinase 3 inhibitor, e.g., SB-216763 (3-(2,4-Dichlorophenyl)-4-(1-methyl-1H-indol-3-yl)-1H-pyrrole-2,5-dione) or a pharmaceutically acceptable salt or derivative thereof.

Abstract: This disclosure provides compounds and compositions for activating pyruvate kinase R (PKR) and related methods of manufacturing and using these compounds and compositions.

Abstract: The present invention relates to agents enhancing HuR/ELAV levels for use in the treatment of BRAF-mutated cancers and uses thereof. In particular, the invention relates to the use of agents enhancing HuR/ELAV levels in combination with BRAF inhibitors for the treatment of BRAF-mutated cancers, in particular melanoma and to methods for identifying agents useful for potentiating the effects of BRAF inhibitors, when used in combination.