Disclosed are compositions comprising and methods of using a novel macromolecular assembly comprising PKN3, PDK1 and RhoC (PPRC complex). The PPRC complex was shown to have kinase activity and was found in cells of high malignancy potential, such as particularly aggressive cancers. In some aspects, the invention pro...

Child- resistant bulk dose dispensing packaging unit, and a method for opening the packaging unit, including a container (101) and a lid (102) engaged with the container. The container includes a reservoir, an aperture (103) at a top end of the reservoir, and a protrusion (704) extending from a surface of the contai...

The present invention relates to new recombinant raccoon poxvirus vectors comprising two or more exogenous nucleic acid molecules, each encoding at least one feline protein, wherein at least two of the nucleic acid molecules are inserted into the hemagglutinin (ha) locus or the thymidine kinase (tk) locus, or at lea...

In one aspect, the invention relates to an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B. Each mutant toxin includes a glucosyltransferase domain having at least one muta tion and a cysteine protease domain having at least one mutation, r...

The present teachings relate to 4-imidazolidinones of Formula (I) which are useful as Kv1.5 potassium channel inhibitors providing atrial-selective antiarrhythmic activity. The present teachings further relate to compositions and methods for treating atrial-selective antiarrhythmia.

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated...

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated...

The present invention provides solid compositions comprising a 3-cyanoquinoline, SKI-606, and further comprising croscarmellose sodium, Tween, or both.

The present invention relates to immunogenic conjugates comprising S. aureus serotype 5 and 8 capsular polysaccharides conjugated to carrier proteins and methods for their preparation and use. Methods for making the immunogenic conjugates of the invention involve covalent conjugation of the capsular polysaccharides ...

The present invention provides binding proteins and antigen-binding fragments thereof, including human antibodies, that specifically bind to the human interleukin-21 receptor (IL-21R), and methods of using them. The binding proteins can act as, e.g., antagonists of IL-21R activity, thereby modulating immune response...

The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2- pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethy!amino)-2-butenamide, methods of preparing crystalline maleate salt forms, the associated compounds, and pharmaceutical compositions containing the same. The maleate s...

The present invention relates to compositions and methods of use comprising peptidyl-prolyl isomerase (PPI) polypeptides of group C and G streptococci and polynucleotides encoding same. The invention also relates to immunogenic compositions comprising the PPI polypeptides and polynucleotides, as well as antibodies a...

A combination of HKI-272 compound and a vinorelbine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, optionally in combination with other anti-neoplastic age...

The invention relates to novel designer osteogenic proteins having altered affinity for a cognate receptor nucleic acids encoding the same and methods of use therefor. More preferably the novel designer osteogenic proteins are designer BMPs and have altered affinity for a cognate BMP receptor. The designer BMPs demo...

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14,18C, 19A, 19F and 23F) conjugated ...

The invention provides methods of inducing an antigen-specific immune response in a subject by using a combination of immunogenic compositions. Generally, the method involves administering to the subject an effective amount of two different immunogenic compositions, both of which comprise bluetongue virus serotype 8...

The present invention relates to compositions including an isolated non pyruvylated non lipidated ORF2086 polypeptide and methods thereof. In an exemplary embodiment the compositions described herein are immunogenic. The present invention further relates to compositions that elicit a bactericidal immune response in ...

The present invention relates to a shuttle BAC vector for facilitating the cloning, transfer and heterologous expression of streptomycete secondary metabolite biosynthetic gene clusters. The invention also relates to a plasmid rescue method using this vector for enhancing the process of cloning biosynthetic gene clu...

The present invention provides a compound of formula I and the use thereof for the treatment of a central nervous system disorder related to or affected by the histamine-3 receptor.

The present invention relates to immunological compositions comprising sulpholipo-cyclodextrin (SL-CD) and, saponin or Quil A, and optionally at least one antigen. The invention relates to methods and immunological compositions comprising at least one antigen, which may be a veterinary antigen. The veterinary antige...

The present invention provides live, attenuated Mycoplasma bacteria that exhibit reduced expression of one or more proteins selected from the group consisting of pyruvate dehydrogenase, phosphopyruvate hydratase, 2-deoxyribose-5-phosphate aldolase, and ribosomal protein L35, relative to a wild-type Mycoplasma bacter...

The present invention provides live, attenuated Mycoplasma gallisepticum bacteria that exhibit reduced expression of a protein identified as MGA_0621. In certain embodiments, the attenuated bacteria may additionally exhibit reduced expression of one or more proteins selected from the group consisting of pyruvate deh...

Methods for producing proteins, for example, recombinant meningococcal 2086 proteins, using fed-batch fermentation with continuous input of an inducer after achieving a threshold parameter, and optionally continuous input of a carbon source, for example, a constant rate input, to improve protein yields, as well as h...

The present invention provides a compound of formula I: wherein X", R1, and R2 are as defined herein, and compositions thereof.

Processes and methods of purifying or separating single domain antigen binding (SDAB) molecules that include one or more single binding domains (e.g., one or more nanobody molecules), substantially devoid of a complementary antibody domain and an immunoglobulin constant region, using Protein A-based affinity chromat...

The invention relates to novel designer osteogenic proteins having altered affinity for a cognate receptor nucleic acids encoding the same and methods of use therefor. More preferably the novel designer osteogenic proteins are designer BMPs and have altered affinity for a cognate BMP receptor. The designer BMPs demo...

The present invention relates to immunogenic conjugates comprising S. aureus serotype 5 and 8 capsular polysaccharides conjugated to carrier proteins and methods for their preparation and use. Methods for making the immunogenic conjugates of the invention involve covalent conjugation of the capsular polysaccharides ...

Provided are immunogenic and vaccine compositions and methods for their preparation and use, which compositions are effective in protecting against, minimizing the severity of, preventing, and/or ameliorating M. hyopneumoniae infection. Administration to an animal of one or two doses of an adjuvanted live avirulent ...

The invention provides methods of immunotherapy of Alzheimer"s and similar diseases in which the regime administered to a patient depends on the ApoE genotype of the patient.

The present invention  provides  improved  methods for producing  a solution containing high molecular weight isolated Streptococcus pneumoniae capsular polysaccharides having phosphodiester linkages between saccharide repeat units. In certain methods, CO2 is supplied to a fermentation culture of Streptococcus p...

The present invention is directed towards a lyophilized or reconstituted multi antigen or multicomponent immunogenic composition comprising at least one antigen isolated from a staphylococcal bacterium and methods of making the same.

The present teachings relate to 4-imidazolidinones of Formula (la) or (lb) which are useful as Kv1.5 potassium channel inhibitors providing atrial-selective antiarrhythmic activity. The present teachings further relate to compositions and methods for treating atrial-selective antiarrhythmia. ...

The present invention relates to methods for generating genetically modified and attenuated strains of vesicular stomatitis virus (VSV) for use in the preparation of immunogenic compositions. More particularly, the invention relates to the identification of particular genetic modifications of attenuated VSV that res...

A nutritional supplement, and methods of use thereof, are provided that are designed to be most effective in optimizing health, improving energy and appearance, reducing the effects of environmental stress and improving, aiding, assisting a person's immunity, including but not limited to decreasing the instances, du...

The present invention provides for antibodies that bind to Notch1. The present disclosure also provides methods of making the antibodies pharmaceutical compositions comprising these antibodies and methods of treating disorders with the antibodies and pharmaceutical compositions.

The present invention relates to the isolation and identification of two new strains of type 2B porcine circovirus. These two new strains of porcine circovirus may be used for the preparation of vaccine or immunogenic compositions for immunizing pigs against postweaning multisystemic wasting syndrome (PMWS), Accordi...

A bone cement delivery method that includes inserting a portion of a bone cement delivery device Into a femoral neck of a femur of a patient, and injecting bone cement paste into the femoral neck of the patient via the bone cement delivery system.

The present invention provides, among other things, methods of purifying or recovering proteins, in particular, small modular immunopharmaceutical (SMIPs™) proteins, from protein preparations containing high molecular weight (HMW) aggregates and other impurities based on hydroxyapatite chromatography. In som...

Disclosed are anti 5T4 antibody drug conjugates and methods for preparing and using the same.

Compounds of formula A: and pharmaceutically acceptable salts thereof are described, which selectively inhibit Raf kinase activity and are useful for treating disorders mediated by Raf kinases.

An extended regimen for treatment of HER-2/neu overexpressed/amplified cancer is described, with involves delivering a course of neratinib therapy to HER-2/neu overexpressed/amplified cancer patients following the completion of surgical and adjuvant therapy. The neratinib regimen may be continued for upwards of twel...

Compounds of formula wherein: r1is and R2, R4, and R6-9 are defined herein, and pharmaceutlcally acceptable salts and esters thereof. These compounds Inhibit PI3 kinase and mTOR, and may be used to treat diseases mediated by PI3 kinase and mTOR, such as a variety of cancers. Methods for making and using the compo...

A portable moist heat delivery system comprising a water vapor generating portion comprising a water vapor source and a heat source; a water vapor-air regulating portion, said water vapor-air regulating portion comprising a water vapor-air mixing layer, and a water vapor-air distribution layer; said water vapor gene...

TRIAZINE COMPOUNDS AS PI3 KINASE AND MTOR INHIBITORS Compounds of formula I wherein: R1 is and R2, R4, and R6-9 are defined herein, and pharmaceutically acceptable salts and esters thereof. These compounds inhibit PI3 kinase and mTOR, and may be used to treat diseases mediated by PIS kinase and mTOR, such as a var...

A solid dose composition comprising at least one pharmaceutically active ingredient and at least one controlled release agent and method of manufacturing said composition is disclosed. The burst profile of at least one pharmaceutically active ingredient in the composition is regulated by the apparent viscosity of th...

An immunogenic composition comprising a plurality of capsular polysaccharides from Streptococcus pneumoniae serotypes 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F and 23F conjugated to a carrier protein and further comprising at least one preservative preferably 2 phenoxyethanol (2 PE). The preservative containing immunogenic...

The present invention provides, among other things, stable formulations for small modular immunopharmaceutical (SMIP™) proteins. In some embodiments, the present invention provides a formulation containing a lyophilized mixture of a small modular immunopharmaceutical protein, wherein less than 7% of the lyophilized ...

Disclosed are quinoline esters of Formula (I):(I) which are useful as Liver X receptors (LXR) modulators. Pharmaceutical compositions containing quinoline esters of Formula (I) and the use of quinoline esters of Formula (I) in the safe treatment of various skin disorders are also disclosed. Methods for preparing and...

The present invention relates to a new recombinant raccoon poxvirus vector vaccine in which the vector expresses one or more antigenic proteins encoded by multiple open reading frames, preferably the ORF5, ORF6 and/or ORF3/ORF4/ORF7, of one or more porcine reproductive and respiratory syndrome virus strains alone or...

The present invention provides 4-anilino-3-quinolinecarbonitirles compounds useful for treating a subject having an BcrAbl positive leukemia that is resistant to imatinib.

Emulsion vaccine formulations containing an antigen and an adjuvant in the aqueous phase are used for the vaccination of animals wherein the adjuvant is an acrylic polymer and/or dimethyl dioctadecyl ammonium bromide (DDA). These formulations can be prepared by mixing an aqueous phase containing the antigen and adju...

The present invention provides improved methods for producing the aluminum adjuvant A1PO4. In one aspect, the present invention provides a method for producing aluminum phosphate which comprises the steps of mixing a solution of aluminum chloride and a solution of sodium phosphate tribasic to produce an aluminum pho...

The  present  invention  relates  to  maleate  salt  forms  of  (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide, methods  of preparing  crystalline  maleate salt forms,  the  associated  compounds,  and pharmaceutical compositions containing the same.  ...

The invention relates to imidazo[l,5-a]pyrazine derivatives, to processes for preparing them, to pharmaceutical preparations which comprise these compounds and to the pharmaceutical use of these compounds, which are inhibitors of phosphodiesterase 10 (PDE10), as active compounds for treating central nervous syste...

The present invention relates to methods of preparing polymorphic Form A of bazedoxifene acetate, and increasing its stability, and polymorphic Form A prepared by such methods.

Methods and processes for improved recombinant protein production are provided. The methods are useful for production of growth factors, particularly those of the TGF-3 superfamily, including bone morphogenetic proteins (BMPs), such as BMP-2. Suitable host cells are cultured in media where iron is present at a conce...

The present invention provides binding proteins and antigen-binding fragments thereof that specifically bind to the human interleukin-21 receptor (IL-21R). The binding proteins can act as, e.g., antagonists of IL-21R activity, thereby modulating immune responses in general, and those mediated by IL-21R in particular...

The disclosure provides novel molecules related to growth and differentiation factor-8 (GDF8), in particular epitopes specific to GDF8 and other specific antagonists of GDF8 in particular anti-GDF8 antibodies or antigen binding protein or fragment thereof which may inhibit GDF8 activity and signal in vitro and/or in...

The invention relates to 3H-[l,2,3]triazoio[4,5-d]pyrimidine compounds of the Formula I: or a pharmaceutically acceptable salt thereof, wherein the constituent variables are as defined herein, compositions comprising the compounds, and methods for making and using the compounds.

The present invention relates to polynucleotides encoding Streptococcus group C and G polypeptides and their use in immunogenic compositions. The invention also relates to immunogenic compositions comprising polypeptides encoded by those polynucleotides. In addition, the invention relates to methods of inducing an i...

The present invention provides novel insecticidal devices, and methods for controlling insects in a homeothermic animal.

A combination of a 4-anilino-3-cyanoquinoline compound (e.g. HKI-272, SKI-606, EKB-569) and a capecitabine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, o...

The present invention relates to infectious bronchitis (IB) viruses derived from a recently identified genotype of IB virus known as IB-QX1, or from viruses that are genetically related to IB-QX, herein referred to as IB-QX-like viruses. The IB viruses of the invention may be live and attenuated or inactivated. Live...

A veterinary anthelmintic composition comprising: a) at least 10% w/v of a benzimidazole antnlemintic; and b) a water-immiscible solvent system, which comprises a lactone solvent, an essential oil, and surfactant.

A number of ß-hemolytic streptococci polynucleotides and polypeptides, particularly Streptococcus pyogenes polypeptides and polynucleotides, are described. Two or more of the polypeptides of the invention can be formulated for use as immunogenic compositions. Also disclosed are methods for immunizing against and red...

The present invention provides improved methods for producing a solution containing high molecular weight isolated Streptococcus pneumoniae 19A capsular polysaccharides. In certain methods, a fermentation culture of Streptococcus pneumoniae bacterial cells that produce serotype 19A capsular polysaccharides is fe...

The invention relates to 1-(arylsulfonyl)-4-(piperazin-1-yl)-1H-benzimidazole compounds of the Formula I: or a tautomer, stereoisomer, or pharmaceutically acceptable salt thereof, wherein the constituent variables are as defined herein, compositions comprising the compounds, and methods for making and using the co...

The present invention provides a compound of formula I as defined herein before and the use thereof for the treatment of a central nervous system disorder related to or affected by the histamine-3 receptor

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 ...

The present invention relates to stable formulations of Neisseria meningitis r LP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation of Neisseria meningitis rLP2086 Antigens and methods for determining the potency of Neisseria meningitis...

A method of quantitatively measuring the total lactoferrin content of an infant formula using electrophoresis and infrared fluorescence detection.

The present invention provides a compound of formula I and the use thereof for the treatment of a central nervous system disorder related to or affected by the histamine-3 receptor.

An immunogenic composition having 13 distinct poiysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14,18C, 19A, 19F and 23F) conjugated ...

The present invention relates to immunogenic compositions, comprising polypeptides and polysaccharides from Staphylococcus aureus. The present invention also relates to immunogenic compositions, comprising Staphylococcus aureus capsule polysaccharides conjugated to a carrier protein. In addition, the invention relat...

The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide, (NERATINIB) methods of preparing crystalline maleate salt forms, the associated compounds, such as its degradation and impurities and pharmaceutical ...

A pharmaceutical pack, comprising: i) a unit dose of vinorelbine or a pharmaceutically acceptable salt thereof; and ii) 50-300 mg of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide (“HKI-272”) or a pharmaceutically acceptable salt thereof, wherein the p...

A method is disclosed for preparing hydrazide linker from hydrazine, which comprises the steps of (a) cooling a reaction vessel comprising a stirred inert solvent to a desired low temperature; (b) adding hydrazine in a continuous fashion to said reaction vessel thereby preparing a stirred substantially uniform slur...

A method is disclosed for preparing hydrazides from hydrazine and an acyl chloride which comprises the steps of (a) preparing a stirred substantially uniform slurry comprising hydrazine and an inert solvent at low temperature; and (b) adding an acyl chloride continuously to said slurry. The method avoids or limits p...

The invention relates to thienopyrimidine and pyrazolopyrimidine compounds of the Formulas (Ia) and (IIa), or a pharmaceutically acceptable salt thereof, wherein the constituent variables are as defined herein compositions comprising the compounds, and methods for making and using the compounds. ...

A nutritional supplement for adults fifty years and older, and methods of use thereof, are provided that are designed to be most effective in optimizing health, improving vitality and immunity, and improving, aiding, eye and bone health.

A METHOD OF PREPARING AN IMMUNOCONJUGATE. A method is disclosed for preparing an immunoconjugate of a member of the family of calicheamicins with a monoclonal antibody as carrier, which comprises preparing a monoacylated hydrazide where the acyl group contains an S-protected mercapto function, removing the protect...

In one aspect, the invention relates to an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B. Each mutant toxin includes a glucosyltransferase domain having at least one mutation and a cysteine protease domain having at least one mutation, rela...