Abstract: The present invention concerns the use of aprotic polar solvents, water, and an ionization stabilizing agent to prepare device compatible stable therapeutic formulations by dissolving a therapeutic agent (active ingredient) in an aprotic polar solvent system that can then be used with various devices (e.g., pumps, infusion sets) for administration of the formulation. In certain embodiments, the invention is directed to formulations comprising one or more therapeutic agents, as well as methods of making such formulations, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system, such as a DMSO/water admixture, comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

Abstract: Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.

Abstract: Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.

Abstract: Disclosed are methods of treating pain in a mammal, which may include the step of administering human growth hormone to a mammal in need thereof The pain treated by the disclosed methods may be of a type caused by inflammation induced mechanical and/or thermal hypersensitivity, and may include, for example, a pain type resulting from one or more conditions selected from peripheral injury pain, post-operative pain, cutaneous inflammation, cutaneous incision, muscle incision, or chronic pain. Disease states in which the disclosed methods may be used include fibromyalgia, sickle cell anemia, epidermolysis bullosa, erythromelalgia, complex regional pain syndrome, or generalized muscle pain.

Abstract: A method for treating or reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in neonates utilizes a relative high dose of nasally administered insulin. In one aspect, the method includes intranasally administering, to a neonate in need thereof, an effective dose of insulin comprising between 350 U to 2000 U insulin.

Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.

Abstract: The present invention relates to PTH prodrugs, pharmaceutical compositions comprising such PTH prodrugs and their uses.

Abstract: This invention generally relates to pharmaceutical compositions for use in the treatment of pain and inflammation, the prevention and improvement of symptoms of musculoskeletal distress degeneration, including temporary loss of range of motion, temporary inflammation, temporary muscle soreness, and combinations thereof, to assist recovery following exercise and recovery of muscles and joints therefrom, and to provide relief of such symptoms in a mammalian organism, said compositions comprising: (i) an analgesically and anti-inflammatory effective amount of a undenatured cartilage including an isolated native Type II collagen; and (ii) an analgesically and antitussively effective amount of at least one non-steroidal anti-inflammatory agent including aspirin, celecoxib, diclofenac, ibuprofen, indomethacin, naproxen, oxaprozin and piroxicam, or a therapeutically active stereoisomer thereof substantially free of its other stereoisomers; and optionally (iii) a pharmaceutically acceptable amount of at least one exc

Abstract: The present invention is directed to a method of replacing collagen broken down during physical activity using a novel dietary supplement. The supplement composition of the present invention comprises collagen, glutamine, taurine, and, optionally, the nine essential amino acids. The uptake of collagen is enhanced using this combination of components to levels substantially near the pre-workout levels.

Abstract: Provided are fragments of human p97 (melanotransferrin) polypeptides having blood-brain barrier (BBB) transport activity, including variants and combinations thereof, conjugates comprising the p97 fragments, and related methods of use thereof, for instance, to facilitate the delivery of therapeutic or diagnostic agents across the BBB and into the central nervous system.

Abstract: The present invention, provides a method of treating cognitive impairment of Hunter syndrome.

Abstract: A wide-spectrum antibacterial pharmaceutical formulation comprising lysozyme and methods of treatment to prevent or cure diseases of bacterial etiology. Excipients provided in the pharmaceutical formulation comprising lysozyme enhance the stability and efficacy of lysozyme for treating bacterial infections in a mammal. The pharmaceutical formulation comprising lysozyme does not produce harmful secondary effects on tissues or organs during prolonged treatment. The formulation can be used to treat bacterial infections of the skin, mucosal regions, and administered into the blood stream of a patient, including respiratory infections. The formulation is useful in treating bacterial infections, including those that occur along with viral infections, particularly viral infections with a respiratory component, including COVID-19.

Abstract: A targeted therapeutic including a lysosomal enzyme and a lysosomal targeting moiety that is a peptide containing at least one N-linked glycosylation site. Methods of producing the targeted therapeutic may include nucleotide acids encoding the same and host cells co-expressing GNPT. Pharmaceutical compositions comprising the targeted therapeutic and methods of using the same to treat a lysosomal storage disease.

Abstract: The present disclosure provides methods and compositions useful for the prophylactic and therapeutic amelioration and treatment of infections caused by Gram-negative bacteria, including Pseudomonas aeruginosa. The disclosure further provides compositions and methods of incorporating and utilizing lysin polypeptides of the present disclosure for augmenting the efficacy of antibiotics generally suitable for the treatment of Gram-negative bacterial infection.

Abstract: The disclosure provides a pharmaceutical composition for fistula treatment in children. The pharmaceutical composition includes a fibrinogen, a thrombin and a coagulation factor XIII. Wherein a dose of the fibrinogen is between 20 mg/mL and 200 mg/mL. A dose of the thrombin is between 1 IU/mL and 20 IU/mL. A dose of the coagulation factor XIII is less than or equal to 10 IU/mL. The fistula in children is anal fistula or urethra fistula. The disclosure further provides a use and a method of the pharmaceutical composition for fistula treatment in children. The application of the pharmaceutical composition, the use and the method of the present invention are advantageous for fistula treatment in children.

Abstract: The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.

Abstract: The present invention provides compositions, methods, and systems for treating inflammatory conditions (e.g., by inhibiting reactive oxygen species) in or on a subject with maspin, maspin derivatives, or maspin mimetics. In some embodiments, such agents are applied to the skin of a subject (e.g., to reduce skin aging).

Abstract: Disclosed herein are methods of vaccination against cancer by providing a sample of a photo-inactivated Leishmania optionally transgenically modified to express a cancer antigen such as alpha-enolase; optionally providing an effective amount of an alpha-enolase; and delivering an effective amount of the sample and/or the alpha-enolase to a patient in need thereof.

Abstract: A therapeutic vaccine and a method of cancer treatment by inducing humoral and cellular immune responses against malignant cells is provided. The vaccine comprises a delivery system that incorporates at least one peptide whose sequence encompasses a genetic mutation associated with a malignancy (neoantigen), at least one immunostimulant, and at least one type of lipid molecule.

Abstract: The invention relates to therapeutic nanobiologic compositions and methods of treating patients who have had an organ transplant, or who suffer from atherosclerosis, arthritis, inflammatory bowel disease including Crohn's, autoimmune diseases including diabetes, and/or autoinflammatory conditions, or after a cardiovascular events, including stroke and myocardial infarction, by inhibiting trained immunity, which is the long-term increased responsiveness, the result of metabolic and epigenetic re-wiring of myeloid cells and their stem cells and progenitors in the bone marrow and spleen and blood induced by a primary insult, and characterized by increased cytokine excretion after re-stimulation with one or multiple secondary stimuli.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in 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: Described herein are anti-CD277 antibodies which: activates or inhibit the cytolytic function of V?9/V?2 T cells, and/or costimulates T cells together with CD3-TCR, and/or costimulates T cells in addition to CD28-B7 costimulation, and/or increases the activity and/or survival of monocytes and dendritic cells. The use of said antibodies in therapy is also described.

Abstract: A vaccine containing an epitope of a heat shock protein 90 and uses thereof are disclosed. The epitope(s) of heat shock protein 90 has the amino acid sequence of SEQ ID NO: 1 and/or 2. A multi-epitope vaccine containing the epitope(s) and a method for treating or preventing cancer using the same are disclosed.

Abstract: The present invention provides a combination vaccine comprising one or more antigens of Mycoplasmahyopneumoniae, one or more antigens of Porcine circovirus, and pharmaceutically acceptable excipients and/or carriers, for use in the prevention and/or treatment of porcine enzootic pneumonia and/or Porcine Circovirus-Associated Diseases (PCVAD) by administration of the vaccine into the dermis of livestock, wherein the one or more antigens of porcine circovirus comprises the PCV2 ORF2 protein in an amount from 0.1 ?g/dose to 10 ?g/dose.

Abstract: Disclosed is the attenuated Salmonella typhi vaccine Ty21a utilized as a vector for Shigella and/or enterotoxogenic E. coli genes stably integrated in the Ty21a chromosome. These genes include a heterologous Shigella sonnei O-antigen biosynthetic gene region that comprises the wzz gene and expresses Shigella sonnei form 1 O-antigen, as well as a heterologous acid resistance biosynthetic gene system comprising a YbaS gene, which enables increased stability of the Ty21a vector at pH 2.5 relative to Ty21a without the integrated acid resistance biosynthetic gene system.

Abstract: Provided are vaccine compositions and methods against Streptococcus pneumoniae. The composition comprises liposomes which have polysaccharides from one or more serotypes and have proteins non-covalently attached to the surface and exposed to the exterior.

Abstract: Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.

Abstract: The present invention pertains to the field of industrial scale inactivation of various enteroviruses and large and industrial scale production of enterovirus vaccine compositions and combinations of various enteroviruses so obtained.

Abstract: A vaccine composition for administration to the oral cavity of a human or an animal, the vaccine composition containing at least one antigen derived from an infectious disease, and at least one selected from the group consisting of a toll-like receptor 4 (TLR4) agonist, a toll-like receptor 2/6 (TLR2/6) agonist, and cyclic dinucleotide, or a derivative or salt thereof.

Abstract: A fusion protein is provided which is based on a self-assembling gene-regulatory NSP10 protein and a protein or peptide capable of being fused to NSP10 without interfering with the assembly or aggregation of the resulting fusion protein. The disclosure also relates to any nanoparticle formed thereby whether complete or not, and methods for the use of the NSP10 fusion protein are also disclosed, including use as vaccines for any indication in humans or animals, therapeutic methods involving the use of the fusion proteins such as using the protein to targeted an antibody or receptor, such as for treating or diagnosing cancer, biosensors using the fusion protein, or the use of the fusion proteins in cell sorting or any imaging application.

Abstract: The present disclosure provides compositions and methods useful for treating Glioblastoma Multiforme (GBM), e.g., compositions comprising virus-like particles (VLPs) comprising Moloney Murine leukemia virus (MMLV) core proteins and the human cytomegalovirus epitopes, gB and pp65, formulated with GM-CSF, which, at dose of at least 10 ?g gB/pp65Gag, reverse dysregulation of anti-HCMV immunity in GBM patients.

Abstract: Recombinant herpes simplex virus 2 (HSV-2) vaccine vectors, virions thereof, compositions and vaccines comprising such, and methods of use thereof are each provided.

Abstract: Provided is a hepatitis B treatment vaccine based on an inactivated whole recombinant Hansenula polymorpha cell which expresses HBsAg and HBcAg. An HBsAgVLP and an HBcAgVLP expressed in the recombinant Hansenula polymorpha cell are used as antigens, the amino acid sequence of the HBsAg expressed by the recombinant Hansenula polymorpha contains a total of 19 CTL epitopes, the amino acid sequence of the HBcAg expressed by the recombinant Hansenula polymorpha contains a total of 19 CTL epitopes, and the inactivated whole recombinant Hansenula polymorpha cell is used as an adjuvant.

Abstract: Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier.

Abstract: This invention generally relates to biomarkers useful in the treatment of IL-23 related diseases, in particular inflammatory diseases such as psoriasis. The invention also relates to methods of using the biomarkers disclosed herein, for example in therapies utilizing IL-23 antagonists.

Abstract: The present invention relates to the prevention or treatment of atherosclerosis, in particular to a B cell depleting agent for the prevention or treatment of atherosclerosis.

Abstract: The invention provides compositions and methods for treating CEA-positive cancers. The method comprising administering a PD-1 axis binding antagonist and a bispecific antibody that targets CEA and CD3.

Abstract: The present application describes uses for Pertuzumab, a first-in-class HER2 dimerization inhibitor. In particular, the application describes methods for extending progression free survival in a HER2-positive breast cancer patient population; and combining two HER2 antibodies to treat HER2-positive cancer without increasing cardiac toxicity.

Abstract: The present document describes methods and uses of compositions which comprise at least one photoactivator or chromophore in association with a pharmacologically acceptable carrier for use in reducing pain that is associated with a medical condition in a subject.

Abstract: The present invention relates to a pharmaceutical topical gel solution that contains 5-aminolevulinic acid (5-ALA) and an aqueous low viscous gel matrix. This invention also relates to a pharmaceutical preparation containing this composition. The formulation of this type can be used in photodynamic therapy as well as in the photodynamic detection of abnormally proliferating cells.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.

Abstract: Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.

Abstract: The invention relates to pharmaceutical compositions in liquid form comprising pradofloxacin in an aqueous solution and citric acid or thioglycerol as antioxidants.

Abstract: In one aspect, provided herein is a nanocarrier composition for formulating a hydrophilic and aromatic low molecular-weight drug (HALMD), the composition comprising: an aromatic polymer; and a hydrophilic and aromatic low molecular-weight drug (HALMD); wherein the aromatic polymer has a positive or negative charge or is a zwitterion, and the hydrophilic and aromatic low molecular-weight drug (HALMD) has an opposing positive or negative charge or is a zwitterion; and wherein the composition has a size of between 50-400 nm and optionally, a zeta potential of from +100 to ?100 mV. A method for preparing the nanocarrier composition, as well as pharmaceutical compositions and therapeutic uses thereof, are also disclosed.

Abstract: Described herein are novel compositions comprising resorbable polyester polymers, such as poly-L-lactic acid particles, including novel compositions that function as neocollagenic dermal implants and that have unique physical properties as compared to compositions of similar composition previously known and/or used in the art. Also provided herein are novel systems comprising these compositions and related compositions and methods of using such compositions and systems, such as in aesthetic treatment.

Abstract: Described herein are drug delivery systems for delivering biologically active agents comprising primary or secondary amines, or a ring nitrogen atom of an azaheteroaryl ring, pharmaceutically acceptable salts thereof, drug delivery reagents related thereto, pharmaceutical compositions comprising the drug delivery systems, and the use of the drug delivery systems as sustained release therapeutics.

Abstract: Compounds and methods are described herein that are useful in brachytherapy. A compound of the present invention may comprise: a cancer cell targeting agent (e.g., transferrin); a protecting group; a cross-linking moiety; and an enzyme (e.g., a protein, ribozyme, abzyme, or abiological catalyst). Compounds and methods of the present invention may be used for localizing a radioactive compound and/or for creating a self-amplifying response.

Abstract: The present invention provides a method of treating multiple myeloma using polymeric pegylated carfilzomib compounds, and pharmaceutically acceptable salts thereof, of Formula I wherein R1, R2, linker, PEG, n and o are as defined herein.

Abstract: Disclosed herein is a hyaluronan conjugate, which includes a hyaluronic acid (HA), a sex hormone, and a linker for coupling one of the disaccharide units of the HA and the sex hormone. Also disclosed herein are the uses of the hyaluronan conjugate in treating or preventing neurodegenerative diseases.