Abstract: The present disclosure relates to the field of synthesizing substantially pure varenicline and its intermediates. It also relates to the pharmaceutical compositions comprising varenicline and the method of use of these pharmaceutical compositions for smoking cessation.

Abstract: The invention provides a method of treating retinal degenerations, such as but not limited to anterior segment ocular disorders and/or age-related macular degeneration (AMD), in a subject, the method comprising administering to the subject a pharmaceutical composition comprising an effective amount of a compound of formula (1) or formula (2). In a further aspect, the invention provides compounds of formula (2). In certain embodiments, the compounds of the invention prevent or minimize cellular assault, such as oxidative stress-related cellular assault, and/or promote cell viability.

Abstract: Provided is a method to identify subjects with inflammatory diseases, such as inflammatory bowel disease, for their suitability for treatment with antifungal compounds. The method comprises identification of loss-of-function in the gene CX3CR1.

Abstract: This disclosure provides compounds and compositions and methods of using those compounds and compositions to treat diseases and disorders associated with excessive transforming growth factor-beta (TGF?) activity. This disclosure also provides methods of using the compounds in combination with one or more cancer immunotherapies.

Abstract: A tumescent composition comprising a drug or a therapeutic agent in a tumescent solution, wherein a tumescent concentration of the drug or therapeutic agent is simultaneously below a threshold for local, subcutaneous tissue toxicity, above a threshold for positive local therapeutic effect, and above a concentration safely achievable by intravenous (IV), intramuscular (IM) or oral (PO) delivery; and the tumescent solution comprises a vasoconstrictor; a pharmaceutically acceptable carrier; and optionally a local anesthetic, wherein the tumescent solution does not comprise an antibiotic.

Abstract: The invention provides two crystalline freebase forms of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester. The invention also provides pharmaceutical compositions comprising the crystalline freebase or prepared using the crystalline freebases; processes and intermediates for preparing the crystalline freebases; and methods of using the crystalline freebases to treat a pulmonary disorder.

Abstract: The invention relates to amorphous folate salt. The salt consists of a folate anion and an organic cation. The folate anion is selected from the group consisting of 5-formyl-(6S)-tetrahydrofolic acid, 10-formyl-(6R)-tetrahydrofolic acid, 5-methyl-(6S)-tetrahydrofolic acid, (6S)-tetrahydrofolic acid, 5,10-Methylene-(6R)-tetrahydrofolic acid, and its oxidized derivatives JK12A and Mefox, and the cation is an organic compound selected from the group arginine, choline, acetylcholine, 1,1-dimethyl-biguanidin and phenylethylbiguanidin. The cation is an organic compound with a complementary pharmacological activity.

Abstract: This disclosure relates to the identification of a subset of mGluR network gene CNVs that are predictive of efficacy of treatment with fasoracetam, as well as the identification of an mGluR network gene CNV that is predictive of an increased likelihood of having ADHD as well as having certain symptoms associated with ADHD.

Abstract: Provided are methods for improving resuspendability of a paliperidone palmitate extended-release injectable suspension within a syringe, for reducing a force required for injection of a paliperidone palmitate extended-release injectable suspension, or for reducing the likelihood of incomplete injection of a paliperidone palmitate extended-release injectable suspension comprising maintaining the syringe in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage. Also provided are populations of syringes that respectively contain paliperidone palmitate extended release injectable suspension, wherein each of the syringes have been shipped to a destination, and the syringes were each maintained in a desired orientation during shipping of the syringe that varies from the orientation of the syringe during pre-shipping storage.

Abstract: The present disclosure is directed to pharmaceutical compositions comprising a PDE V inhibitor and one or more pharmaceutical excipients or additives wherein the pharmaceutical compositions are in the form of liquid pharmaceutical compositions. The pharmaceutical compositions of the present disclosure are useful for the treatment of diseases or conditions which are treatable by administration of PDE V inhibitor drug such as pulmonary arterial hypertension, erectile dysfunction, etc.

Abstract: The present invention includes a method of preventing and/or treating a fibrotic lung disease in a subject. In certain embodiments, the method comprises administering to the subject a thyroid receptor ?-agonist. The invention further comprises compositions useful within the invention, as well as kits comprising compositions useful within the invention.

Abstract: A new approach to treatment of hematological malignancies. A GAB1 inhibitor for use in a method of treatment of a hematological malignancy is disclosed. The GAB1 inhibitor may be administered alone, or simultaneously or sequentially with a BTK inhibitor to achieve a synergistic effect.

Abstract: The present invention relates to carbamoyl phenylalaninol compounds and methods of using the same to treat disorders. The invention further relates to the development of methods for treating excessive sleepiness in a subject, e.g., due to narcolepsy or obstructive sleep apnea, with the surprising outcome that “normal” levels of wakefulness are achieved based on standard objective and subjective sleepiness tests.

Abstract: The invention provides two crystalline freebase forms of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester. The invention also provides pharmaceutical compositions comprising the crystalline freebase or prepared using the crystalline freebases; processes and intermediates for preparing the crystalline freebases; and methods of using the crystalline freebases to treat a pulmonary disorder.

Abstract: Various embodiments of this invention are directed to pharmaceutical compositions and methods for treating disease. The compositions of such embodiments include dicarboxylic acid compounds containing electron withdrawing groups, alkyl esters of dicarboxylic acids containing electron withdrawing groups, or compounds of Formulae I to X. The methods of various embodiments include administering an effective amount of any of these pharmaceutical compositions to a patient in need of treatment.

Abstract: This invention relates to compounds. More specifically, the invention relates to compounds useful as inhibitors of the Wnt signalling pathway. Specifically, inhibitors of Porcupine (Porcn) are contemplated by the invention. In addition the invention contemplates processes to prepare the compounds and uses of the compounds. The compounds of the invention may therefore be used in treating conditions mediated by the Wnt signalling pathway, for example treating cancer, sarcoma, melanoma, skin cancer, haematological tumors, lymphoma, carcinoma, and leukemia; or enhancing the effectiveness of an anti-cancer treatment.

Abstract: The application describes creatine or its derivatives, compositions comprising the same, and uses thereof for topical or systemic administration to treat pain, itch, or eczema, or inflammation associated with a cosmetic or medical condition, disorder or disease in a human subject, wherein the inflammation causes the pain, itch, or eczema. In addition, the application describes clinical use of these compounds and compositions which can reduce or eliminate erythema, edema and tissue distortions associated with inflammation.

Abstract: There are provided methods of treating edible matter comprising applying a composition comprising performic acid to the edible matter or a substrate therefor. Other embodiments are also disclosed.

Abstract: The present invention provides new methods of treatment for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, circadian rhythm sleep disorders, sleep and vigilance disorders associated with Parkinson's disease, multiple sclerosis, dementia or attention deficit hyperactivity disorder by administering a therapeutically effect amount of histamine-3 receptor (H3R) inverse agonist, N-[4-(1-Cyclobutylpiperidin-4-yloxy)phenyl]-2-(morpholin-4-yl)acetamide or a pharmaceutically acceptable salt thereof. The present invention further provides use of the said compounds in the manufacture of medicament intended for the treatment of the disorders described herein.

Abstract: Provided are compositions and methods comprising a FOXO inhibitor for increasing proliferation of Lgr5+ cochlear cells, and related methods of treating hearing loss.