Abstract: Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

Abstract: A biocompatible material for bone repair is described. The bone repair composition includes a mixture of a type I collagen, a type I collagen-glycosaminoglycan coprecipitate, tricalcium phosphate; and bioactive glass. Methods of using the composition for bone repair, and a kit for the bone repair composition are also described.

Abstract: A process for preparing an acid resistant cellulose capsule. An example of a process for preparing an acid resistant cellulose capsule includes the steps of: i) preparing 100 wt part of aqueous solution of solubilized cellulose including 15-25 wt part of cellulose; ii) sequentially adding and solubilizing: 2.0-4.0 wt part of amid pectin and 0.1-1.0 wt part of iota-carrageenan as a gelling agent, an auxiliary gelling agent, a pH neutralizing agent, an emulsifying agent, a viscosity stabilizing agent and a plasticizing agent to the resulting admixture; and iii) allowing it to stand and to be equilibrated with adjustment of viscosity, before forming the capsule.

Abstract: Provided are methods of generating an immune response to any of various antigens including foreign antigens such as infectious agent antigens. In general, the method comprises administering an expression vector encoding a transcription unit encoding a secretable fusion protein, the fusion protein containing the foreign antigen and CD40 ligand and also administering the encoded fusion protein. In another approach, an immune response to the foreign antigen is elicited using the encoded fusion protein without administering the vector. The invention methods may be used to immunize an individual against an infectious agent such as influenza virus. Methods of obtaining an immune response in older individuals also is described.

Abstract: A liquid dispensing razor including a reservoir containing a shave care composition. The shave care composition comprises water; one or more lipophilic skin conditioning agents; one or more thickening agents including electrolyte sensitive polymers; one or more emulsifying agents; and one or more lubricants. The shave care composition is delivered to the skin by the razor to provide skin comfort and moisturization benefits during the shave. The combination of the chemistry in the razor results in step change in skin condition in consumer and technical skin moisturization benefits.

Abstract: The invention generally relates to compositions and methods for treating snake envenomation in animals, including humans. In some aspects, the invention provides therapeutic compositions that contain one or more toxin binding molecules including, for example, anti-toxin antibodies and binding fragments.

Abstract: Provided are adenoviral vectors for generating an immune response to antigen. The vectors comprise a transcription unit encoding a secretable polypeptide, the polypeptide comprising a secretory signal sequence upstream of a tumor antigen upstream of CD40 ligand, which is missing all or substantially all of the transmembrane domain rendering CD40L secretable. Also provided are methods of generating an immune response against cells expressing a tumor antigen by administering an effective amount of the invention vector. Further provided are methods of generating an immune response against cancer expressing a tumor antigen in an individual by administering an effective amount of the invention vector. Still further provided are methods of generating immunity to infection by human papilloma virus (HPV) by administering an effective amount of the invention vector which encodes the E6 or E7 protein of HPV. The immunity generated is long term.

Abstract: A composition for human consumption includes a base composition having a pH of about 2 to about 5 and encapsulated caffeine dispersed throughout at least a portion of the base composition. The encapsulated caffeine can be a caffeine complex. The base composition can include a liquid or a food. An oral pouch product includes a porous pouch wrapper, an inner botanical filling material contained within the pouch wrapper, and encapsulated caffeine dispersed throughout at least a portion of the oral pouch product. The encapsulated caffeine is included in the composition and/or the oral pouch product an amount sufficient to release about 50 mg to about 200 mg of caffeine. The composition can provide immediate release of caffeine and/or release of caffeine over an extended period of time.

Abstract: A buffered body fluid expander solution, in which the buffer is a physiologically acceptable buffer that is not an inorganic phosphate buffer, comprises calcium ions and magnesium ions at a concentration ratio of 5:1 to 1:1. The solutions are useful for the manufacture of medicaments and blood volume expanders, for treating hypovolemia or for treating the loss of extracellular and interstitial fluid in subjects suffering with burns, for treating respiratory and/or metabolic acidosis in a subject, for perfusion of the abdominal cavity during peritoneal dialysis of a subject with acute renal failure or an acute toxicity condition, for preventing and/or ameliorating reperfusion injury, and for delivering a therapeutic, test and/or synergistic agent to a subject, including a biological agent, such as at least one stem cell, peptide or genomic derived protein.

Abstract: Methods of administering methyldopa to a subject in a fasting state to increase bioavailability of the methyldopa.

Abstract: The present invention provides an oligodeoxynucleotide containing humanized K type CpG oligodeoxynucleotide and poly deoxyadenylate, wherein the poly deoxyadenylate is placed on the 3?-side of the humanized K type CpG oligodeoxynucleotide. In addition, the present invention provides a complex containing the aforementioned oligodeoxynucleotide and ?-1,3-glucan.

Abstract: There is disclosed derivatives of amanitin conjugated to a targeting antibody to form an ADC (antibody drug conjugate).

Abstract: The present disclosure provides monoclonal antibodies against protein programmed cell death 1 (PD-1), which can block the binding of PD-1 ligands to PD-1, and therefore block the inhibitory function of PD-1 ligands on PD-1 expressing T cells. The antibodies of disclosure provide very potent agents for the treatment of multiple cancers via modulating human immune function.

Abstract: Provided in the present invention are a monoclonal antibody FnAb8 and application thereof.

Abstract: Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

Abstract: A hyaluronic acid product is comprising a cross-linked hyaluronic acid and one or more cyclodextrin molecules, and further comprising a guest molecule capable of forming a guest-host complex with the aminocyclodextrin molecule acting as a host, wherein the guest molecule is a retinoid, preferably adapalene, or a RAM BA. The hyaluronic acid is cross-linked by ether bonds, and the one or more cyclodextrin molecules are grafted onto the cross-linked hyaluronic acid by amide bonds, preferably using a triazine-based coupling reagent.

Abstract: Homologs of the E. coli proteins orf353, bacterial lg-like domain (group 1) protein (orf405), flu antigen 43 (orf1 364), NodT-family outer-membrane-factor-lipoprotein efflux transporter (orf1 767), gspK (orf3515), gspJ (orf3516), toriB-dependent siderophore receptor (orO597), fibrial protein (orf3613), upec-948, upec-1232. A chain precursor of the type-1 fimbria! protein (upec-1875), yapH homolog (upec-2820), hemolysin A (recp-3768), and Sel 1 repeat-containing protein (upec-521 1) from several pathogenic strains of E. coli have been identified with regions within the proteins that are conserved across all E. coli. Fragments corresponding to the conserved regions, especially immunogenic fragments such a linear B-epitopes, are provided.

Abstract: Polypeptides, and methods for their use, are disclosed that have an amino acid sequence at least 75% identical to the amino acid sequence of SEQ ID NO:1, are provided, wherein (a) the polypeptide degrades a PFQPQLPY (SEQ ID NO: 140) peptide and/or a PFPQPQQPF (SEQ ID NO: 68) at pH 4; (b) residue 467 is Ser, residue 267 is Glu, and residue 271 is Asp; and (c) the polypeptide comprises an amino acid change from SEQ ID NO: 1 at one or more residues selected from the group consisting of 221, 262E, 268, 269, 270, 319A, 320, 354E/Q/R/Y, 358S/Q/T, 368F/Q, 399, 402, 406, 424, 449, 461, 463, 105, 171, 172, 173, 174, and 456.

Abstract: Anti-PD-1 antibodies and antigen-binding fragments thereof are described. Also described are nucleic acids encoding the antibodies, compositions comprising the antibodies, and methods of producing the antibodies and using the antibodies for treating or preventing diseases such as cancers and autoimmune diseases.

Abstract: The present disclosure relates to methods for making extended-release formulations of water-soluble active pharmaceutical ingredients such as metformin HCl. In one aspect, the disclosure provides a method that includes adding an aqueous solution of an active pharmaceutical ingredient to an agitated mixture of one or more release-modifying polymers and optionally one or more binders in one or more organic solvents, the one or more organic solvents together being an antisolvent for the active pharmaceutical ingredient, water being sufficiently soluble in the one or more organic solvents such that the water added as part of the aqueous solution dissolves in the mixture, the addition thereby precipitating the active pharmaceutical ingredient; separating the active pharmaceutical ingredient and the one or more release-modifying polymers and, if present, the one or more binders from the one or more organic solvents to yield co-processed particles; and drying the co-processed particles.