Abstract: The present invention relates to pharmaceutical composition comprising pemetrexed, a ready to use injection comprising pemetrexed. Liquid composition of pemetrexed comprises head space oxygen less than 5%, dissolved oxygen less than 2 ppm and individual impurity level less than 0.2%.

Abstract: Provided are methods and compositions for treating cancers in patients carrying an IDH2 mutation using a combination of an inhibitor of a mutant IDH2 enzyme and a DNA demethylating agent.

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: The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and/or a salt thereof, and optionally, a hostile biophysical environment and/or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and/or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

Abstract: Described herein are methods of treating narcolepsy with cataplexy, comprising administering reboxetine (including esreboxetine) to a human being in need thereof. Reboxetine (including esreboxetine) may also be used in the manufacture of a medicament for the treatment of narcolepsy with cataplexy. Also disclosed herein are kits comprising a pharmaceutical composition comprising reboxetine (including esreboxetine) and instructions to use the pharmaceutical composition to treat narcolepsy with cataplexy in a human being.

Abstract: Described herein are methods of treating narcolepsy with cataplexy, comprising administering reboxetine (including esreboxetine) to a human being in need thereof. Reboxetine (including esreboxetine) may also be used in the manufacture of a medicament for the treatment of narcolepsy with cataplexy. Also disclosed herein are kits comprising a pharmaceutical composition comprising reboxetine (including esreboxetine) and instructions to use the pharmaceutical composition to treat narcolepsy with cataplexy in a human being.

Abstract: The present disclosure relates to methods of a malignant rhabdoid tumor (MRT), a rhabdoid tumor of the kidney (RTK), an atypical teratoid/rhabdoid tumor (AT/RT), an epithelioid malignant peripheral nerve sheath tumor, a myoepithelial carcinoma, and/or a renal medullary carcinoma by using an EZH2 inhibitor in combination with one or more additional treatment modalities.

Abstract: The present disclosure relates to meloxicam bolus formulations and methods of administering the same intravenously, for treatment of pain, which can provide fast onset of pain relief suitable for management of acute moderate to severe pain.

Abstract: Methods for the treatment of EGFR mutated cancer. For example, treatment of non-small cell lung cancer (NSCLC) with activating EGFR mutations (e.g., L858R and ex19del), the acquired or resistant “gatekeeper” T790M mutation, or any combination of these mutations.

Abstract: The present invention provides methods for treating cancer using combinations of bromodomain and extra-terminal (BET) protein inhibitors and certain chemotherapeutic drugs.

Abstract: A compound for use in the treatment of itch is provided, wherein the compound comprises the general formula (1a), general formula (1b) or general formula (1c). The compounds of the invention are positive allosteric ?2 and/or ?3 GABAA receptor modulators.

Abstract: The present invention relates to methods of treating hypogonadism in a male subject through administering intranasally to the male subject an intranasal testosterone bio-adhesive gel formulation to deliver a therapeutically effective amount of testosterone. In particular, the testosterone therapy of the invention remains effective if an allergic rhinitis event occurs in the male during the treatment or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.

Abstract: Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.

Abstract: The present invention relates to methods of preventing, inhibiting, delaying, and/or mitigating seizures by administration of a steroid, e.g., a neurosteroid, e.g., allopregnanolone.

Abstract: Phase-inverted capsules of a prodrug of budenoside are provided for treatment of bowel diseases

Abstract: Disclosed is a storage-stable pharmaceutical formulation for rectal administration, containing budesonide or a pharmaceutically compatible salt or derivative thereof, and at least 80 wt % of a solid fat or a mixture of different solid fats, based on the total weight of the formulation, as well as at least one anti-oxidation agent that is compatible therewith.

Abstract: The present invention relates to a S1PR4-targeting composition for preventing or treating non-alcoholic steatohepatitis and, more particularly, to a pharmaceutical composition and a health functional food composition, both comprising a sphingolipid compound which serves as a functional inhibitor against S1PR4, showing prophylaxis and therapy of non-alcoholic steatohepatitis. The sphingolipid compound of the present invention is expected to be applied as a leading material effective for the prevention or treatment of non-alcoholic steatohepatitis (NASH) as it has the effect of reducing the infiltration of inflammatory cells into hepatic tissues and suppressing fibrosis and decreases a level of liver injury (ALT), inflammation in hepatic tissues, the expression of a fibrosis-related gene.

Abstract: This present invention relates to a stable lyophilized composition of Cyclophosphamide. The said stable lyophilized composition of Cyclophosphamide provides an improved moisture content than the lyophilized Cyclophosphamide compositions obtained by the conventional lyophilization method. Further, the invention relates to a process for preparation of the said stable lyophilized composition of Cyclophosphamide, wherein the said process comprises controlled lyophilization with freezing and annealing at a temperature above 0° C.

Abstract: The invention relates to a synthetic composition comprising human milk oligosaccharides for use in at least partially restoring the commensal gastrointestinal microbiota and preventing or mitigating antibiotic associated diarrhoea.

Abstract: Use of ginsenoside M1 for manufacturing a medicament for treating Huntington's disease (HD) in a subject in need; and a pharmaceutical composition for use in treating HD comprising ginsenoside M1 and a pharmaceutically acceptable carrier.

Abstract: The present invention relates to the field of viral disorders, and in particular to the use of natural compounds to inhibit viruses and viral infection. Compositions comprising NGNA are provided for treating or preventing viral infections, such as those causing the common cold.

Abstract: Disclosed is NUC-1031 (gemcitabine[phenyl-benzoxy-L-alaninyl)]-phosphate), a ProTide derivative of gemcitabine, for use in targeting cancer stem cells. This targeting of cancer stem cells may be employed in the prevention or treatment of cancer. NUC-1031 may be used in treatment of relapsed or refractory cancer in a human patient. Without wishing to be bound by any hypothesis, it is believed that the ability of NUC-1031 to target cancer stem cells contributes to its utility in the treatment of relapsed or refractory cancers.

Abstract: Compositions and methods are presently disclosed that provide improved efficiacy for the treatment of cancer. In particular, 3-O-ribose monoester derivatives of adenosine triphosphate are observed to have vastly superior efficiacy over a previously reported compound, 3,5 benzoylbenzoyl adenosine triphosphate. These novel compounds have been shown to increase calcium channel activation mediated by the P2X7 receptor thereby resulting in increase apoptosis of cancer cells, either malignant or benign.

Abstract: The present disclosure generally pertains to methods of treating myocardial infarct involving administering a platelet anti-aggregate, a cysteine-aspartic protease inhibitor, and reperfusion therapy. In certain embodiments, the platelet anti-aggregate is at least one P2Y12 receptor antagonist or Glycoprotein IIb/IIIa inhibitor, the cysteine-aspartic protease inhibitor is selected from the group consisting of Caspase-1, 4, 5, 11 and 12 inhibitors, and reperfusion therapy is percutaneous coronary intervention. In certain embodiments, the at least one P2Y12 receptor antagonist is selected from the group consisting of cangrelor, ticagrelor, clopidogrel and prasugrel. The disclosed methods provide an improved cardioprotective effect against infarction when compared with the current standard of care.

Abstract: Provided herein are methods for the treatment of Alport syndrome, using a modified oligonucleotide targeted to miR-21. In certain embodiments, the modified oligonucleotide targeted to miR-21 improves kidney function and/or reduces fibrosis in subjects having Alport syndrome. In certain embodiments, administration of the modified oligonucleotide targeted to miR-21 delays the onset of end-stage renal disease in a subject having Alport syndrome. In certain embodiments, the modified oligonucleotide targeted to miR-21 delays the need for dialysis or kidney transplant in a subject having Alport syndrome.

Abstract: Described are compositions and methods for inhibition of Hepatitis B virus gene expression. RNA interference (RNAi) agents for inhibiting the expression of Hepatitis B virus gene are described. The HBV RNAi agents disclosed herein may be targeted to cells, such as hepatocytes, for example, by using conjugated targeting ligands. Pharmaceutical compositions comprising one or more HBV RNAi agents optionally with one or more additional therapeutics are also described. Delivery of the described HBV RNAi agents to infected liver in vivo provides for inhibition of HBV gene expression and treatment of diseases and conditions associated with HBV infection.

Abstract: Disclosed is a preparation method of a starch-based hemostatic powder, comprising the following steps: (1) starch modification; (2) emulsification and crosslinking; (3) separation, purification, drying and sterilization. Provided is a starch-based hemostatic powder, which has a simple preparation process and a controllable cost. After being modified, raw material medical potato starch has a high degree of emulsification and crosslinking and a good and uniform spherical shape, and has a porous structure. Moreover, the product has good biocompatibility, low biological cytotoxicity, and obvious antibacterial effect; the product has a high liquid absorption ratio, and quickly forms a gel to cover the wound surface after liquid absorption, thus achieving a good hemostatic effect. The starch-based hemostatic powder is an excellent biomedical product, and can be used for clinical wound treatment, surgery to prevent organ adhesion, and bleeding from various wounds.

Abstract: The gut microbiota has emerged as a central factor affecting human health and disease, and inflammatory diseases are no exception. The potential role of the gut in the pathophysiology of inflammatory diseases has recently begun to attract increased attention. The inventors show in the murine model of DSS-induced colitis that the prebiotic, polydextrose (PDX), ameliorate survival, increases colon-length and weight gain after settlement of colitis and thus demonstrate that the fibre provides anti-inflammatory properties. Thus PDX would be suitable for the treatment of inflammatory diseases.

Abstract: Described herein are compositions and methods of use thereof for treatment of musculoskeletal disorders by way of administering at least one galectin inhibitor to a subject, such as galactoarabino-rhamnogalacturonan (GR) and derivatives thereof, and galactomannan (GM) and derivatives thereof. In particular embodiments the described compounds are administered in combination with hyaluronic acid or Chitosan.

Abstract: Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.

Abstract: The disclosure pertains to a blood pH modulator for use in improving colostrum intake in offspring of an animal, in improving colostrum production by an animal, and in improving postnatal survival of offspring of an animal. This disclosure also pertains to compositions comprising a blood pH modulator in combination with a calcium binder to supplement a diet of an animal, in particular, a pregnant animal.

Abstract: Methods for enhancing the activity of an ion transporter in a cell and/or treating a channelopathy in a subject based on the administration or use of an effective amount of a fenretinide compound (fenretinide, a fenretinide analog, or a pharmaceutically acceptable salt thereof) and/or zinc are described. The methods are useful for restoring or increasing the cell surface expression of an ion transporter such as the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) that is mutated or defective. The fenretinide compound and/or zinc may be used in combination with ion transporter modulators, e.g., CFTR modulators, to further enhance the cell surface expression and activity of the ion transporter.

Abstract: The present invention pertains to the use of the calcium-sensing receptor (CaSR)-activating nutrients (designated as “CaSR-based nutrients”) for the prevention and/or treatment of diarrheal diseases and inflammation in the gastrointestinal tract. In one embodiment, the current invention is formulated for oral administration. The anti-diarrheal composition of the present invention is useful for treating diarrheal and gastrointestinal inflammatory conditions in infants and young children.

Abstract: Provided herein are macrophages engineered for treating fibrosis and ameliorating the effects of fibrotic lesions in various organs and tissues. Certain embodiments are directed to genetically-engineered macrophages capable of treating fibrosis or reducing fibrotic lesions. In certain aspects macrophages can be genetically-engineered to (1) target extracelluar matrix (ECM) or components thereof, (2) enhance degradation of ECM, or (3) target ECM and enhance degradation of ECM. Further provided is a cellular therapy product comprising a genetically-engineered macrophage comprising at least one of a recombinant targeting protein and a recombinant catalytic enzyme. Further provided is a method of treating an individual for fibrosis comprising administering the cellular therapy product.

Abstract: In certain embodiments internalizing anti-CD146 antibodies and conjugates thereof are provided. It was discovered that anti-CD146 antibodies are capable of targeting both epithelioid and sarcamatous subtypes of mesothelioma cells. In certain embodiments methods of detecting and/or treating mesothelioma are provided.

Abstract: The present invention relates to new CD22 Chimeric Antigen Receptors (CD22 CAR), an engineered immune cell endowed with said new CD22 CAR and comprising at least inactivated TRAC gene for use in therapy. The engineered immune cells endowed with such CARs are particularly suited for treating relapsed refractory CD22 expressing cancers.

Abstract: The present disclosure relates to the field of biotechnology, and more specifically, to single-chain and multi-chain chimeric polypeptides having a linker domain positioned between two target-binding domains that are useful for a variety of applications including, without limitation, stimulating an immune cell, inducing or increasing proliferation of an immune cell, inducing differentiation of an immune cell, or treating a subject in need thereof (e.g., a subject having cancer or an aging-related disease or condition).

Abstract: The present disclosure relates to compositions and methods for enhancing T cell response and/or CAR cell expansion and/or maintenance in vivo and/or in vitro. For example, in a method of in vivo cell expansion, the method comprises administering an effective amount of cells comprising an antigen binding molecule to a subject; and administering an effective amount of presenting cells expressing a solid tumor antigen that the binding molecule binds.

Abstract: The present invention provides improved and/or shortened methods for expanding TILs and producing therapeutic populations of TILs, including novel methods for expanding TIL populations in a closed system that lead to improved efficacy, improved phenotype, and increased metabolic health of the TILs in a shorter time period, while allowing for reduced microbial contamination as well as decreased costs. Such TILs find use in therapeutic treatment regimens.

Abstract: The present invention provides improved and/or shortened methods for expanding TILs and producing therapeutic populations of TILs, including novel methods for expanding TIL populations in a closed system that lead to improved efficacy, improved phenotype, and increased metabolic health of the TILs in a shorter time period, while allowing for reduced microbial contamination as well as decreased costs. Such TILs find use in therapeutic treatment regimens.

Abstract: Disclosed herein are methods for treating cancer comprising administering CAR-modified immune cells and at least one Retinoic Acid Receptor agonist.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use inv immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: Provided herein in some embodiments is a method of treating a disease or condition such as an antibiotic resistant bacterial infection, a gram negative bacterial infection, a gram positive bacterial infection, a fungal infection, protozoa, a hemorrhagic virus, such as Ebola or Dengue, or a non-hemorrhagic virus, such as a coronavirus, in a subject, comprising administering to the subject in need thereof an effective amount of a composition comprising platelets or platelet derivatives, such as freeze-dried platelets; and an incubating agent comprising one or more salts, a buffer, optionally a cryoprotectant, and optionally an organic solvent.

Abstract: Disclosed are new, useful and non-obvious methodologies and compositions of matter for the treatment of chronic traumatic encephalopathy (CTE) using stem cells and cells possessing stem cell-like activity. The treatment of CTE is accomplished by utilizing stem cells to: a) reduce oxidative stress; b) suppress inflammation; c) enhance neurogenesis; and d) stimulate axonal regrowth. In one embodiment said stem cells are mesenchymal stem cells derived from umbilical cord and other perinatal tissues. In another embodiment, said stem cells are bone marrow derived. In yet another embodiment said stem cells are adipose derived. In one embodiment, products derived from said regenerative cells are comprised of cellular lysate, apoptotic bodies, exosomes, and other microvesicles. In one embodiment, said regenerative cells and/or said products derived from said regenerative cells are administered subsequent to one ore multiple head injuries.

Abstract: The disclosure is directed to methods for mobilizing hematopoietic stem cells (HSCs) and/or hematopoietic progenitor cells (HPCs) in a subject using sildenafil citrate and AMD3100.

Abstract: Using lung tissues as a source, mammalian lung progenitor cells lung spheroids and lung spheroid cells (LSCs) were prepared. In one embodiment mammalian LSCs were prepared by (i) culturing mammalian lung tissue explant cells under adherent culture conditions to form a first lung cell outgrowth culture; (ii) culturing the first lung cell outgrowth culture under low-adherence conditions to form lung spheroids; and (iii) culturing the lung spheroids under adherent culture conditions so as to form LSCs. The low-adherence conditions may be a cell culture or suspension. The lung spheroids or LSCs may be formulated into pharmaceutical compositions. Uses such as treatment of lung diseases or diagnostics are also provided. Lung spheroids and LSCs represents a simple and highly reproducible method to generate therapeutic lung cells.

Abstract: A method for Inhibiting or Delaying the Growth of Enterococcus spp. in Animals using at least one Bacillus-based component is disclosed herein.

Abstract: A Bacillus bacterium that induces the production of interleukin-22 is provided. The Bacillus bacterium that induces the production of interleukin-22.

Abstract: Novel Bifidobacterium bacteria having an opioid peptide decomposition action and a noncollagenous glycoprotein decomposition action are provided. The present invention relates to one or more kinds of Bifidobacterium bacteria selected from the group consisting of Bifidobacterium bifidum MCC1092 (NITE BP-02429), Bifidobacterium bifidum MCC1319 (NITE BP-02431), Bifidobacterium bifidum MCC1868 (NITE BP-02432), Bifidobacterium bifidum MCC1870 (NITE BP-02433), and Bifidobacterium longum subsp. longum MCC1110 (NITE BP-02430), as well as a composition for decomposing an opioid peptide and composition for decomposing a noncollagenous glycoprotein containing the Bifidobacterium bacteria as an active ingredient.

Abstract: An object of the present invention is to provide an agent for decomposing an opioid peptide or composition for decomposing an opioid peptide that does not restrict dietary habits, does not provide side reactions, even if it is daily used, and thus can be continuously used without any worries. The object is achieved by an agent for decomposing an opioid peptide or composition for decomposing an opioid peptide, pharmaceutical composition for decomposing an opioid peptide, or food or drink composition for decomposing an opioid peptide containing a Bifidobacterium bacterium, a culture of the bacterium, and/or a processed cell product of the bacterium as an active ingredient.