Abstract: Methods of generating and optimizing stabilized (e.g., stapled and/or stitched) anti-microbial peptides (StAMPs) for the prophylaxis and treatment of antibiotic-resistant (e.g., colistin-resistant, methicillin resistant, meropenem-resistant) bacterial infections (e.g., Gram-negative, Gram-positive), and methods for using such peptides for experimental investigation, livestock management, management of crops/trees/plants, and/or therapeutic benefit. Also featured are methods for reducing renal toxicity of a StAMP.

Abstract: Disclosed is a method of modulating the Sct/SR axis in a mammalian subject in need thereof, including in a subject suffering from a liver disease, such as but not limited to, Early Stage PBC, Primary Sclerosing Cholangitis, Primary Biliary Cholangitis, Biliary Altresia, NASH, NAFLD, or Alcohol induced liver injury. A method of treating Late Stage PBC in a mammalian subject in need thereof is also disclosed; further disclosed is a method of ameliorating PBC-induced biliary damage in a mammalian subject in need thereof. Pharmaceutical compositions for modulating the Sct/SR axis, comprising a SR antagonist or a SR agonist, and a pharmaceutically acceptable carrier or excipient are also disclosed.

Abstract: Provided herein is a method of treating medulloblastoma or glioblastoma in a subject by administering to the subject a PI3K activator (e.g., thymosin ?-4 or a derivative thereof) and one or more chemotherapeutic agents and/or radiation. The combination therapy is effective in the treatment of medulloblastoma or glioblastoma characterized by cells with elevated p53 levels.

Abstract: A topical application of nitric oxide may be provided by two separate containers, each containing an active component media to produce nitric oxide when combined. For example, a nitrite component media may be contained in one dispenser and an acidified component media may be contained in another dispenser. Each dispenser may dispense the respective component media as a foam. The resultant foams are combined to initiate the production of nitric oxide and the mixture of foams is applied topically to treat various skin disorders or wounds.

Abstract: The present invention relates to a peptide exhibiting physiological activities and a composition including the peptide. Because the peptide of the present invention exhibits various physiological activities such as muscle relaxation, skin wrinkle improvement, sebum production suppression, and the like, the peptide may be used as an active ingredient in a pharmaceutical composition for muscle relaxation, or cosmetics for improving skin wrinkles, suppressing sebum production, or ameliorating acne.

Abstract: Disclosed are methods of enhancing the therapeutic efficacy of Fexapotide Triflutate (TF) in treating LUTS, both irritative and obstructive, that include administering a composition comprising FT at least twice over a period spanning more than one year. The methods are capable of providing an enhanced therapeutic effect in treating nocturia, and in improving urinary flow, when compared to the therapeutic effect achieved by administration of the same or twice the total amount of FT administered.

Abstract: This invention relates to a bioerodible drug delivery device that can be implanted in a patient at or near an area in need of treatment. The bioerodible drug delivery device can be used to deliver a wide variety of different pharmaceutically active agents, and can do so at a controlled rate and over an extended period of time. The bioerodible drug delivery device includes a bioerodible polymeric outer housing with one or more delivery ports for delivering the pharmaceutically active agent(s) contained therein. The polymer used as the bioerodible polymeric outer housing is not substantially degraded during the dosing of the pharmaceutically active agent(s) in the bioerodible drug delivery device. The invention also provides methods of making the bioerodible drug delivery device and using it for the treatment of diseases and disorders.

Abstract: The present invention relates to a topical composition and more particularly a topical composition for antimicrobial benefit. According to the present invention there is provided a topical composition comprising Niacinamide and picolinamide wherein the molar ratio of Niacinamide to picolinamide is from I:20 to 20:I.

Abstract: The present disclosure is directed to a composition comprising micronized cromolyn sodium, ?-lactose, and a salt of fatty acid, wherein the ?-lactose has a particle size distribution of D90 of 45-70 ?m, D50 of 10-35 ?m, and D10 of 2-13 ?m. The present disclosure is also directed to a method of treating Alzheimer's disease, amyloidosis-associated condition (AAC), traumatic brain injury, Huntington's disease, atherosclerosis, cytokine release syndrome (CRS), dementia, head injury, infection, neuroinflammation, prion disease, stroke, amyotrophic lateral sclerosis (ALS), Parkinson's disease, or asthma using the composition.

Abstract: The present invention is related to an orally disintegrating, sublingual or buccal formulation of active ingredient such as cannabidiol or tetrahydrocannabinol.

Abstract: The present invention is directed to a composition that includes an amphiphile, its use in a method of preventing and/or treating cancer, and its use in a method of producing a pharmaceutical composition. In certain embodiments, the amphiphile includes a hydrophilic peptide that binds to a Plenty of SH3 domain (POSH) and inhibits or disrupts a POSH scaffold network, a hydrophobic moiety, and an aptamer. The present invention is also directed to other POSH inhibitor complex biomolecules that do not contain a hydrophobic moiety.

Abstract: Disclosed are methods of treating symptoms of Lower Urinary Tract Symptoms (LUTS), both obstructive and irritative, that include identifying patients having benign prostatic hyperplasia (BPH), and who also have LUTS, and administering a composition comprising FT to the so-identified patient. The methods are particularly effective in improving urinary peak flow (Qmax), and in improving nocturia.

Abstract: Described herein are substrate coatings.

Abstract: A pharmaceutical formulation is disclosed which includes at least: (1) elagolix sodium, (2) magnesium oxide, and (3) at least one disintegrating agent, such as crospovidone, croscarmellose sodium, sodium starch glycolate, pregelatinized and mixtures thereof. A tablet is also disclosed which includes a tablet core formed from the pharmaceutical formulation. The elagolix sodium tablets of the present disclosure display improved dissolution rates when tested using for example the Tablet Sink Time test. The tablets also exhibit improved storage stability of the elagolix sodium, with a reduction in degradation products during storage.

Abstract: The invention features a compositions and methods for inducing an immune response to targeted cells. The compositions induce targeting of a cell by positioning carbohydrate epitopes on the surface of the cell by conjugation of the epitope to a pH-triggered membrane peptide (pHLIP®).

Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.

Abstract: Anhydrous compositions including from 3% to 15% by weight of at least one lipophilic gelling agent, from 10% to 50% by weight of fillers including at least 5% by weight of a first filler and at least 5% by weight of a second filler different from the first; and from 40% to 85% by weight of at least one fatty phase are provided.

Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.

Abstract: There are provided, inter alia, compositions including a scintillator nanocrystal linked to a chemical agent moiety through a scintillator-activated photocleavable linker, and methods of use thereof.

Abstract: The present invention concerns pharmaceutical formulations of ARN-509, which can be administered to a mammal, in particular a human, suffering from an androgen receptor (AR)-related disease or condition, in particular cancer, more in particular prostate cancer, including but not limited to castration-resistant prostate cancer, metastatic castration resistant prostate cancer, chemotherapy-naive metastatic castration resistant prostate cancer, biochemically relapsed hormone sensitive prostate cancer, or high-risk, non-metastatic castration-resistant prostate cancer. In one aspect, these formulations comprise a solid dispersion of ARN-509, a poly(meth)acrylate copolymer and HPMCAS. In one aspect, the solid dispersion of ARN-509, a poly(meth)acrylate copolymer and HPMCAS is obtainable, in particular is obtained, by melt-extruding a mixture comprising ARN-509, a poly(meth)acrylate copolymer and HPMCAS and optionally subsequently milling said melt-extruded mixture.