Abstract: Protein formulations and methods for reducing the viscosity of a protein formulation are provided. The method for reducing the viscosity of a protein formulation comprises adding a viscosity reducing agent, such as calcium chloride or magnesium chloride to the protein formulation.

Abstract: Disclosed are compounds of formula (I) and pharmaceutically acceptable salts thereof, wherein X is —O—, —N(R3)—, —S—, —S(O)— or —S(O)2—; R2 is a C1-4 alkyl group or —CF3; and R1, R3, R4 and p are as defined herein; wherein the compounds are useful as kinase inhibitors. Also disclosed are pharmaceutical compositions containing, and intermediate compounds and methods for making the compounds of formula (I) and their pharmaceutically acceptable salts; and methods of using the foregoing to treat inflammatory and autoimmune diseases such as asthma, colitis, multiple sclerosis, psoriasis, arthritis, rheumatoid arthritis, inflammatory bowel disease, and joint inflammation.

Abstract: A topical treatment strip comprising a substrate having two surfaces with a topical composition carried thereupon. The treatment strip can be used to treat two surfaces of subject as such as both lips simultaneously. Methods include methods of manufacture and methods of use.

Abstract: The present invention provides methods for treating MDD. In general, the methods comprise administering to a patient in need thereof a daily dose of about 50 mg ODV or an equivalent amount of a pharmaceutically acceptable salt thereof. In certain embodiments, a patient in need of treatment is characterized by a primary diagnosis of MDD. In some embodiments, the dose is administered as a single daily dose. In one set of embodiments, the methods involve administering an oral dosage form comprising the succinate salt of ODV.

Abstract: The present invention is directed to heat cells that are suitable for incorporation into disposable heating wraps. The heat cells comprise an exothermic composition comprising an absorbent gelling material, wherein the absorbent gelling material provides for improved heat application in the relief of temporary or chronic body aches and pains.

Abstract: Compounds of formula (I) or pharmaceutically acceptable salts thereof are provided: wherein: A is alkylenyl of 1 to 4 carbon atoms, or alkenylenyl of 2 to 4 carbon atoms; R1 and R2 are, independently, hydrogen or a C5 to C7 aryl optionally substituted with 1 to 2 substituents, independently, selected from the group consisting of —C(O)R3, halogen, cyano, nitro, hydroxyl, C1-C6 alkyl, and C1-C6 alkoxy, with the proviso that at least one of R1 and R2 is not hydrogen; R3 is, independently, hydrogen, —OR4, alkyl, aryl, or heteroaryl; R4 is hydrogen, alkyl, aryl, or heteroaryl; R5 and R6 are, independently, hydrogen, alkyl, hydroxyl, alkoxy, or C5 to C7 aryl; wherein any R3 to R6 group having an aryl or heteroaryl moiety can optionally be substituted on the aryl or heteroaryl moiety with 1 to about 5 substituents, independently, selected from the group consisting of halogen, cyano, nitro, hydroxyl, C1-C6 alkyl, and C1-C6 alkoxy.

Abstract: The present invention relates to novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions. These compositions comprise tigecycline, a suitable carbohydrate, and an acid or buffer.

Abstract: Compounds of formula (I) or pharmaceutically acceptable salts thereof are provided where at least one of R2 or R3 is not hydrogen. The compounds of the present invention are N-methyl-D-aspartate (NMDA) receptor antagonists and are useful in treating a variety of conditions present in a mammal that benefit from inhibiting the NMDA receptor.

Abstract: Pharmaceutical compositions and methods of use in regulation of mammalian bone forming activities of sFRPs (secreted frizzled-related proteins) are disclosed. sFRPs are secreted receptors for Wnts, which are important polypeptide growth factors that are known to regulate fundamental biological processes like tissue polarity, embryonic development, and tumorigenesis. A sFRP was isolated from human osteoblast cells and identified as sFRP-1 (also known as SARP-2) and shown to be regulated by osteogenic agents in hOB cells in a differentiation selective manner, modulating the life of osteoblasts/preosteocytes. An sFRP-1 knock-out mouse was generated and deletion of sFRP-1 was found to not affect nonskeletal tissues, skeletal morphology or cortical bone development, while resulting in increased trabecular bone formation, decreased osteoblast and osteocyte apoptosis and increased osteoprogenitor differentiation.

Abstract: The present invention relates to the use of proteins comprising at least one follistatin domain to modulate the level or activity of growth and differentiation factor-8 (GDF-8). More particularly, the invention relates to the use of proteins comprising at least one follistatin domain, excluding follistatin itself, for treating disorders that are related to modulation of the level or activity of GDF-8. The invention is useful for treating muscular diseases and disorders, particularly those in which an increase in muscle tissue would be therapeutically beneficial. The invention is also useful for treating diseases and disorders related to metabolism, adipose tissue, and bone degeneration.

Abstract: A process is described for purifying vesicular stomatitis virus (VSV) from cell culture fluid of a mammalian cell culture infected with VSV, the process comprising: clarifying the cell culture fluid by low-speed centrifugation and recovering the VSV in the supernatant; filtering the supernatant through a 0.2 to 0.45 ?m filter and recovering the VSV in the filtered solution; loading the VSV filtered solution onto a anion exchange membrane adsorber equilibrated with a first pH buffered salt solution, eluting the VSV from the anion exchange membrane adsorber with a second pH buffered salt solution and recovering the eluted VSV fractions; purifying the recovered VSV by tangential flow filtration (TFF) using a TFF membrane having a molecular weight cutoff between 300 kDa and 1,000 kDa and recovering the VSV in the retentate, and filtering the VSV retentate through a 0.2 to 0.22 ?m filter and recovering the VSV in the filtered solution.

Abstract: The present invention provides methods of identifying a clonal population of cells suitable for large-scale production of a protein of interest. The invention further provides methods for high-throughput screening for genetic rearrangements in the gene encoding the protein of interest, whereby the absence of a deletion in the gene encoding the protein of interest indicates that the cell is suitable for large-scale production of the protein of interest.

Abstract: The invention provides improved agents and methods for treatment of diseases associated with amyloid deposits of A? in the brain of a patient. Preferred agents include antibodies, e.g., humanized antibodies.

Abstract: The present invention is directed to a pharmaceutical composition and method for the treatment of rhinitis and cold-like symptoms which includes a non-steroidal anti-inflammatory drug (NSAID), a decongestant, and an antihistamine. It has been found that an NSAID enhances the activity of a decongestant and an anti-histamine, thus permitting a reduction in either or both in administration of separate dosage forms. The same enhancement can also occur with an anti-tussitive. Thus, the effective amount of the decongestant or the antihistamine or both is less than about 75% of an amount present in an approved dose of the decongestant or the antihistamine, or both, relative to an amount of the NSAID corresponding to about 100% of the amount present in a normal strength dosage form of the NSAID.

Abstract: This invention relates generally to imidazo[1,2-b]pyridazine-based modulators of Liver X receptors (LXRs) having formula (I) and related methods: wherein R2 is C6-C10 aryl or heteroaryl including 5-10 atoms, each of which is: (i) substituted with 1 R6, and (ii) optionally substituted with from 1-5 Re; and R1, R3, R4, R5, R6 and Re are defined herein.

Abstract: Compounds of Formula (I), are provided where T is CHO, COR8, or C(OH)R1R2; R1 and R2 are hydrogen, optionally substituted lower alkyl, CF3, optionally substituted alkenyl, or optionally substituted alkynyl; R3 is hydrogen or optionally substituted lower alkyl; R4 is (CF3)nalkyl, (CF3)n(substitutedalkyl), (CF3)nalkylphenyl, (CF3)nalkyl(substitutedphenyl), or (F)ncycloalkyl; n=1-3; R5 is hydrogen, halogen, CF3, diene fused to Y when Y=C, or substituted diene fused to Y when Y=C; W, Y and Z are C, CR6 or N where at least one of W, Y or Z are C; R6 is hydrogen, halogen, or optionally substituted lower alkyl; X is O, S, SO2, or NR7; R7 is hydrogen, optionally substituted lower alkyl, optionally substituted benzyl, or optionally substituted phenyl; and R8 is lower alkyl, CF3, or optionally substituted phenyl. Methods of preparing and using these compounds for inhibiting beta amyloid production and for treatment of Alzheimer's Disease and Down's syndrome are also described.

Abstract: Disclosed herein are compositions which are exothermic upon contact with oxygen and are self-steaming. The various described embodiments include compositions comprising: (a) a fuel component; (b) a water manager component; and (c) water. In one embodiment, the water manager component, has a mean particle size distribution of greater than about 250 microns. Alternatively or additionally, the ratio of the water manager component to the water is from about 0.001:1 to about 0.2:1, by weight. Alternatively or additionally, the fuel component comprises sponge iron. Alternatively or additionally, the composition comprises a volatile component. In yet another embodiment, articles comprising the compositions are described. Further, methods of making the compositions are described.

Abstract: The disclosure provides methods for treating neuromuscular disorders in mammals. The disclosed methods include administering therapeutically effective amounts of a GDF-8 inhibitor and a corticosteroid to a subject susceptible to, or having, a neuromuscular disorder, so as to maintain desirable levels of muscle function.

Abstract: Sodium ibuprofen compositions and methods of manufacturing tablets and caplets comprising sodium ibuprofen are described. The formulation is advantageous because it allows for the formation of tablets having low sodium content and further provides tablets exhibiting improved physical stability, high tablet hardness and high strength, coupled with excellent dissolution and bioavailability characteristics. The formulations and processes are further advantageous because they can be produced in large quantities without an unacceptable number of defective tablets.

Abstract: This invention relates generally to pyrazolo[1,5-a]pyrimidine-based modulators of Liver X receptors (LXRs) having formula (I) and related methods: wherein R2 is C6-C10 aryl or heteroaryl including 5-10 atoms, each of which is: (i) substituted with 1 R6, and (ii) optionally substituted with from 1-5 Re; and R1, R3, R4, R5, R6 and Re are defined herein.