Abstract: The disclosure provides methods of treating solid tumors with a combination of tucatinib, or salt or solvent thereof, and an anti-PD-1 antibody, or an antigen-binding fragment thereof. The disclosure also provides methods of treating solid tumors with a combination of tucatinib, or salt or solvent thereof, and an anti-PD-L1 antibody, or an antigen-binding fragment thereof.

Abstract: The present disclosure provides methods of administering belumosudil mesylate salt to patients with chronic graft-versus-host disease (cGVHD), wherein the methods include identifying adverse reactions in the patients and modifying the administration based on the results of such identification.

Abstract: The present disclosure relates to the co-administration of Belumosudil with CYP3A Inducers and/or Proton Pump Inhibitors for use in the treatment of subjects with chronic graft-versus-host disease (cGVHD).

Abstract: The present disclosure provides methods of administering belumosudil mesylate salt to certain subpopulations of patients with cGVHD.

Abstract: A combination includes 4-[(S)-2-Azetidin-1-yl-1-(4-chloro-3-trifluoromethyl-phenyl)-ethylamino]-quinazoline-8-carboxylic acid amide and/or its physiologically acceptable salts and solvates, an inhibitor of MEK kinase, and as an optional third inhibitor, an inhibitor of EGFR. The combination is useful for the treatment of cancer. Another combination includes 4-[(S)-2-Azetidin-1-yl-1-(4-chloro-3-trifloromethyl-phenyl)-ethylamino]-quinazoline-8-carboxylic acid amide and/or its physiologically acceptable salts and solvates, and an inhibitor of EGFR.

Abstract: This disclosure relates to using compounds disclosed herein to treat or prevent cocaine use disorder, cocaine toxicity, or other drug related disorders. In certain embodiments, this disclosure relates to methods of treating drug addiction or to help prevent relapse. In certain embodiments, this disclosure relates to methods of treating or preventing cocaine use disorder, cocaine toxicity, or other use disorders comprising administering an effective amount of a compound disclosed herein, such as ibrutinib, [(R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one], derivative, or salt thereof to a subject in need thereof. In certain embodiments, the compound is a Bruton's tyrosine kinase (BTK) inhibitor.

Abstract: The disclosure relates generally to alpha polyglutamated pralatrexate, formulations containing liposomes filled with alpha polyglutamated pralatrexate, methods of making the alpha polyglutamated pralatrexate and liposome containing formulations, and methods of using polyglutamated alpha polyglutamated pralatrexate and liposome containing formulations to treat hyperproliferative disorders (e.g., cancer) and disorders of the immune system (e.g., an autoimmune disease such as rheumatoid arthritis).

Abstract: A liquid pharmaceutical composition comprises methotrexate free acid and a buffer, wherein the pH of the composition is in the range of 6.5 to 8.2. Processes for preparation of the liquid pharmaceutical composition are also described. The liquid pharmaceutical composition is useful in therapy.

Abstract: This disclosure relates to ruxolitinib, or a pharmaceutically acceptable salt thereof, and its use in treating prurigo nodularis.

Abstract: Treatments for human subjects exposed to, potentially exposed to, infected by, or potentially infected by a coronavirus, such as SARS-CoV-2, its variants and sub variants are described, which are based on an administration of combination drug products having two or three active ingredients formulated with one or more pharmaceutically acceptable carriers. These patients (children, adults and the elderly) suffer from symptoms of COVID-19, and some may continue to suffer from its aftereffects many weeks or months after an infection, like long COVID, including neurological aymptoms such as brain fog and confusion. Physiological ailments may consist of symptoms such as fatigue, shortness of breath, difficulty breathing, joint and muscle aches, and the like. The two-component combination drug product comprises effective amounts of ANTABUSE (disulfiram) and PURINETHOL (mercaptopurine, 6-mercaptopurine, or 6-MP) or its prodrug IMURAN (azathioprine) or hydrates of these compounds.

Abstract: Provided are methods related to treating congenital adrenal hyperplasia in a subject in need thereof comprising administering to the subject a compound of Formula (I), or a pharmaceutically acceptable salt thereof.

Abstract: The present disclosure relates to pharmaceutical compositions comprising inhibitor(s) of human histone methyltransferase EZH2, and methods of cancer therapy using the EZH2 inhibitor(s).

Abstract: Provided are compositions and methods related to the use of apilimod alone or in combination with glutamatergic agents or other agents for treating neurological diseases and disorders, and for the treatment of cancer.

Abstract: Methods to activate or enhance phosphorylation of focal adhesion kinase (FAK) are provided herein. Methods to treat epithelial disorders in mammals, namely diseases of the gut, comprising the administration of one or more small molecules having FAK activation properties are also provided.

Abstract: The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.

Abstract: The invention relates to methods for the treatment or prevention of anaemia of inflammation comprising administering to a subject in need thereof a therapeutically effective amount of a compound selected from the group consisting of an inhibitor of the Ca2+-activated potassium channel (Gardos channel), an inhibitor of interaction of one or more chemokines with Duffy antigen receptor for chemokines (DARC), and a compound that inhibits activation of adhesion molecules expressed on erythrocytes.

Abstract: A method for modulating tolerance to an opioid analgesic in a patient undergoing opioid analgesic therapy, the method comprising interrupting or administering concurrently with said opioid analgesic therapy an amount of ibogaine, ibogaine derivative, or pharmaceutically acceptable salt and/or solvate thereof.

Abstract: The present invention provides pharmaceutical compositions and methods of treating Covid-19 infectious disease. The present invention also provides pharmaceutical compositions and methods of prophylaxis or prophylactic treatment of Covid-19 infectious disease. The said methods involve administering compositions comprising therapeutically effective amount of Cannabidiol thereby causing enhancement/augmentation of innate immunity of the patient/mammal/human due to at least one of the following effects, i) infected patient cells undergo apoptosis early after infection; ii) induction of interferon transcription in the patient; iii) induction of interferon-induced antiviral effectors in the patient.

Abstract: The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.

Abstract: Alleviation of vascular disorder such as vasculitis or angialgia is required in the use of a water-soluble drug causing vascular disorder. According to the present invention, a composition containing a water-soluble drug causing vascular disorder; a solution for use in preparation of an administration solution containing a water-soluble drug causing vascular disorder; and a kit including a water-soluble drug preparation causing vascular disorder and the aforementioned solution, each of which contains a nonionic surfactant in an amount necessary for alleviation of vascular disorder, are provided.

Abstract: As described below, the present disclosure features compositions containing a cannabidiol (CBD) and/or psilocybin, optionally in combination with a mushroom blend. The present disclosure also features methods for treating or preventing migraine, or symptoms thereof, with a cannabidiol and/or psilocybin, optionally in combination with a mushroom blend. The present disclosure also features compositions and methods of using psilocybin in combination with a neurotransmitter activity modulator for the treatment of neurological conditions (e.g., migraine), or symptoms thereof (e.g., anxiety or depression).

Abstract: The present disclosure provides pharmaceutical formulations of the compound of Formula I, Formula Ia, or Formula Ib, or a pharmaceutically acceptable salt thereof, and an aqueous vehicle. The pharmaceutical formulations of the disclosure are useful in treatment and prevention of viral infections in subjects in need thereof and are for administration by inhalation.

Abstract: Use of lenvatinib, or a pharmaceutically acceptable salt thereof in combination with a compound of the formula MIV-818: or pharmaceutically acceptable salt thereof, in the treatment of liver cancer or liver metastases. The respective dosage regimes of the compounds can be delivered concurrently or alternately.

Abstract: The present invention relates to fucosylated human milk oligosaccharides for improving sleep maturation, for example improving trouble sleeping, in a non-infant.

Abstract: The present invention relates to methods for the treatment of metastatic cancer. Methods of treating metastatic cancer by administration of a set of drugs overcome multiple mechanisms of melphalan resistance and hypersensitize cancer cells to melphalan are described. The methods involve the administration of drug(s) that induce oxidative stress in cancer cells, in conjunction with melphalan on a defined schedule.

Abstract: Methods of reconstituting lyophilized Annamycin and methods of treating patients are described.

Abstract: CD73 (also known as ecto-5?-nucleotidase) inhibitor compounds are provided, as well as compositions and uses thereof for treating or preventing CD73-associated or related diseases, disorders and conditions, including cancer- and immune-related disorders. CD73 inhibitor compounds include compounds having the structure set forth in Formula I? and pharmaceutically acceptable esters or salts thereof.

Abstract: Prodrugs of 6-mercaptopurine (6-MP) and methods of their use for treating cancers and autoimmune diseases are disclosed.

Abstract: Provided herein are compositions and formulations for alleviating problems associated with unregulated intraocular pressure (IOP) in an eye comprising the administration of Trabodenoson. Administration of Trabodenoson results in reversing or blocking disease progression of glaucoma and other related disorders. Trabodenoson also restores functionality of the pressure sensor in an eye.

Abstract: The present invention provides novel compounds that target thrombocyte activity or aggregation capacity through cellular components for the treatment of diseases associated with Non-Alcoholic Fatty Liver Disease (NAFLD). The invention provides these compounds for treating non-alcoholic steatohepatitis (NASH), a progressed stage of NAFL (non-alcoholic fatty liver), in order to avoid the development of liver cirrhosis and Hepatocellular Carcinoma (HCC). Further provided are pharmaceutical compositions, comprising the compounds of the invention, and methods for screening new NASH therapeuticals.

Abstract: Disclosed is an anticancer composition containing auranofin and a mercapto compound and the use thereof. The composition contains auranofin and the mercapto compound. By the combined use of auranofin and the mercapto compound, the problem that auranofin cannot effectively inhibit the proliferation of cancer cells under normal physiological condition is solved. When combined with the mercapto compound, auranofin can inhibit tumor growth well, indicating that the combination of auranofin and the mercapto compound can be used as an anticancer drug composition. Moreover, the uptake of auranofin in tumor tissues also can be adjusted by regulating the type of mercapto compound, and thus, providing better selectivity in vivo anti-cancer.

Abstract: A topical composition that destroys an external hyperplastic tissue, while preserving a basic architecture of the external hyperplastic tissue rather than dissolution of hydrolysis of protein peptide bonds of the external hyperplastic tissue, thereby providing a timely regeneration of healthy skin tissue after the external hyperplastic tissue has been treated with the topical composition, and thereby contributing to less damage to surrounding healthy skin tissue, as a result of, destructive potential of the topical composition being effectively neutralized and penetration of the topical composition into the surrounding healthy tissue being effectively blocked. The topical composition includes a caustic portion and a detoxifying and cleansing portion. The caustic portion has a caustic effect on the external hyperplastic tissue.

Abstract: Disclosed are topical mucoadhesive compositions comprising hyaluronic acid or a salt thereof, choline alfoscerate, an ascorbic acid ester at a concentration ranging between 0.050% w/w and 0.0004% w/w, and at least one pharmaceutically acceptable excipient or carrier.

Abstract: The present invention relates to methods for attenuating aging, of health maintenance, and/or treating, or delaying the onset of, an age-related condition or disorder, in a subject comprising administering to the subject an effective amount of (a) one or more compounds that sustain pharmacological activation of xenobiotic metabolism or induce fermentation by gut bacteria to produce substances that activate xenobiotic metabolism enzymes and/or stimulate xenobiotic excretion and (b) one or more chelators. A further aspect of the invention is a composition comprising (a) and (b).

Abstract: Provided is a method of contacting a subject, cell, or tissue with an amphiphilic block copolymer to treat a viral infection. The resulting effect can be treating a disease caused by a virus, inhibiting viral replication, inhibiting an unfolded protein response of a virus, preventing death of tissue infected by a virus, or promoting cell repair and recovery to increase survival of cells infected by a virus. The hydrophobic block of the amphiphilic block copolymer binds to an exposed hydrophobic domain of the virus. Further provided is an amphiphilic block copolymer comprising three or more hydrophobic substituents or an alkylene spacer on a hydrophobic block of the copolymer.

Abstract: The present invention is directed to an orally disintegrable multi-layered particle comprising a hydrophobic core containing simethicone, a hydrophilic surfactant layer, and a hydrophilic disintegrant layer; wherein said hydrophilic surfactant layer is located between the hydrophobic core and the hydrophilic disintegrant layer; and orally disintegrable solid dosage forms comprising said multi-layered particle, and related processes.

Abstract: The invention relates to method of treating chronic inflammatory diseases in subjects in need thereof by administering calcium lactate as an active agent. The calcium lactate can be provided in a pharmaceutical, food, or nutrient composition.

Abstract: A method of preparing an iron hydroxide product is provided. The method includes the steps of: adding a first base solution to a solution of a ferric salt to obtain Mixture A having a pH value of 2.7-2.8, adding a second base solution to Mixture A to prepare a crude iron hydroxide suspension having a pH value of 2.8-3.8, and adding a third base solution to adjust the pH of the crude iron hydroxide suspension to 5-9, followed by purification and concentration, thereby obtaining a purified polynuclear iron hydroxide suspension containing polynuclear iron hydroxide. Also provided are nano iron complexes, e.g., iron hydroxide carbohydrate complex and their preparation methods.

Abstract: The present invention provides methods of improve efficiency, growth, and performance in an animal by orally administering to the animal an effective amount of a therapeutic clay. The methods can reduce embryonic loss, increase litter size, increase the number of live births, improve the immune status of the maternal animal, reduce the concentration of maternal fecal amino acids, reduce the concentration of maternal fecal short-chained amino acid, increasing litter birth weight in the maternal animal, increase the amount of young animal colostrum intake, reduce young animal pre-weaning mortality, reduce the number of young animals lost due to low viability, reduce the number of weaned young animals, improve the immune status of young animals at weaning, reduce the number of lightweight young animals from nursery to market, increase the number of young animals marketed per sow, and increase calculated litter weight gain.

Abstract: A CD19-OR-CD20 chimeric antigen receptor (CAR) protein construct is provided. Also provided are nucleic acids encoding the CD19-OR-CD20 CAR; and methods of use, e.g. in the treatment of B cell malignancies. The CD19-OR-CD20 CAR of the invention is a bispecific CAR that can trigger T-cell activation upon detection of either CD19 or CD20 (or both). It is a single molecule that confers two-input recognition capability upon human T cells engineered to stably express this CAR.

Abstract: The invention provides methods of making immune effector cells (e.g., T cells, NK cells) that can be engineered to express a chimeric antigen receptor (CAR), and compositions and reaction mixtures comprising the same.

Abstract: The disclosed invention provides a method of treating a central nervous system (CNS) disease or disorder comprising administering to a subject diagnosed with the CNS disease or disorder a composition comprising a population of genetically modified, programmed cell death-1 receptor ligand (PD-L1)+-expressing hematopoietic stem cells (HSCs), wherein the CNS disease or disorder involves inflammation of the CNS. In one embodiment, the CNS disease or disorder is Multiple Sclerosis (MS). In certain aspects, the hematopoietic stem cells (HSCs) are obtained from a subject having a CNS disease or disorder prior to modification.

Abstract: Compositions and methods are provided for the achievement of organ and tissue transplantation and autoimmune tolerance using the infusion of living and/or deceased donor hematopoietic cells. The methods provided herein provide for conditioning with a plurality of doses of total lymphoid irradiation (TLI), and a single, very low dose of TBI (svldTBI), referred to herein as “TLI-svldTBI-ATG” or “TLI-svldTBI” depending on whether ATG is included. The combination of svldTBI and TLI specifically targets non-lymphoid-tissue resident memory immune cells. An in vitro manipulated donor cell composition is provided for use with the conditioning regimen, in which specific ratios of CD34+ and other hematopoietic stem cell and precursor cell populations are combined with defined doses of CD3+ T cells, and/or purified regulatory T cells (Treg) cells, invariant natural killer (iNK-T) cells, and/or CD8+ memory T cells.

Abstract: Methods and compositions are provided to treat limb ischemia such as Beurger's Disease through the use of bone marrow stem cells that are administered prior to, concurrently with, and subsequently to administration of agents that modify the microenvironment of the ischemic limb(s). In one embodiment, said agents are antioxidants, more specifically antioxidants capable of diffusing across ischemic areas and preserving regenerative activity of administered stem cells. In another embodiment, the invention provides hormonal modifications to overcome deficiencies associated with ischemia predisposing pathologies.

Abstract: A composition for tendon and ligament regeneration includes a biologically compatible hydrogel suspension having spherical droplets. The spherical droplets have a diameter of about 100 ?m to about 300 ?m and a plurality of cells. The cells include marrow-derived mesenchymal stem cells (MSCs) with an average viability of about 90% or greater and cells that retain their stemness. A method for tendon and ligament regeneration includes forming the composition, purifying the composition, retrieving the composition, and administering the composition via injection into an injury site of injured tissue.

Abstract: Disclosed are methods, means, and compositions of matter useful for enhancing regenerative activity of bone marrow mononuclear cells/aspirate by coadministration with oxytocin. In one embodiment the invention teaches the treatment of peripheral artery disease by intramuscular administration of oxytoxin and bone marrow mononuclear cells/aspirate in proximity. The invention provides therapeutic doses, kits, and adjuvants useful in enhancing regenerative activity of bone marrow mononuclear cells/aspirate.

Abstract: The present disclosure provides methods of treating or preventing respiratory condition and/or for treating an IgE-mediated allergy and/or for reducing an allergic response to an allergen and/or for inducing anergy to an allergen in a subject and/or improving lung function in a subject suffering from an allergy comprising administering to a subject a population of cells enriched for STRO-1+ cells and/or progeny thereof and/or soluble factors derived therefrom.

Abstract: Disclosed is a method for effectively preparing mesenchymal-like stem cells, the method including: preparing human pluripotent stem cells cultured to passage 70 or lower after establishment of cell lines; inducing differentiation of the human pluripotent stem cells to produce embryoid bodies and selecting cystic embryoid bodies therefrom; loading the cystic embryoid bodies on a cell-permeable three-dimensional (3D) culture unit to isolate mesenchymal-like stem cells therefrom; isolating only monolayer-shaped cell clusters from the mesenchymal-like stem cells passing through the cell-permeable 3D culture unit; and uniformizing sizes of the monolayer-shaped cell clusters, in which the mesenchymal-like stem cells have anti-inflammatory efficacy and immunosuppression.

Abstract: As described below, the present invention features compositions and methods for neuroprotection and/or neuroregeneration of damaged or degenerating neurons. In various embodiments, the compositions and methods of the present disclosure are used to treat a neurodegenerative disease and/or nervous system injury. The methods in various embodiments include reducing or eliminating activity or expression of a target gene(s) and/or a polypeptide(s) expressed by a target gene(s) in a neuron.

Abstract: Provided herein is method of treating a skin condition in a subject, comprising isolating cells comprising primary dermal fibroblasts from a skin sample obtained from the subject, and administering the freshly-isolated cells to skin of the subject. Also provided are freshly isolated cell preparations comprising primary dermal fibroblasts and uses thereof.