Abstract: The invention provides methods of treating an allergic inflammatory condition characterized by inflammation of the squamous epithelium of a target tissue by administering to the subject a pharmaceutical composition comprising a kallikrein 5 (KLK5) inhibitor, and a pharmaceutically acceptable carrier.

Abstract: The present invention provides, among other things, methods and compositions for treating primary ciliary dyskinesia (PCD) based on mRNA therapy. The compositions used in treatment of PCD comprise an mRNA comprising a dynein axonemal heavy chain 5 (DNAH5) coding sequence and are administered at an effective dose and an administration interval such that at least one symptom or feature of PCD is reduced in intensity, severity, or frequency or has a delayed onset. mRNAs with optimized DNAH5 coding sequences are provided that can be administered without the need for modifying the nucleotides of the mRNA to achieve sustained in vivo function.

Abstract: The present disclosure provides pharmaceutical compositions for treating fungal and bacterial infections. The pharmaceutical compositions of the disclosure comprise a cationic surfactant, a chelating agent, and at least one solvent. The pharmaceutical compositions of the disclosure can be used to treat drug-sensitive or multi drug-resistant bacterial or fungal infections.

Abstract: This disclosure relates to methods for the prevention of the reduction of disulfide bonds in a polypeptide expressed in a recombinant host cell, comprising, following fermentation, adding selenite and/or its salts or derivatives to a harvest solution of the recombinant host cell, wherein the disulfide bond in the polypeptide remains non-reduced.

Abstract: The invention relates to novel infective agents, the use thereof for the production of a pharmaceutical composition for the treatment and prophylaxes of a disease, preferably an infectious disease, a pharmaceutical composition comprising said compound, and to methods of producing said compounds. The invention further relates to a new probiotic configured for preventing or reducing the colonization by a pathogenic microorganism of an organ of a living being.

Abstract: Nootropic compositions and methods of providing or using the same are provided herewith. Some preferred compositions include a combination of free amino acids and one or more peptides. Compositions may optionally include one or more of an anti-adherent, a B vitamin, shilajit, a sugar, a fatty acid, ashwaganda, ginseng, or rodiola, among other things.

Abstract: This invention relates to improved uses of botulinum neurotoxins in the treatment of sialorrhea or diseases or conditions relating to increased saliva production. In particular are botulinum neurotoxins disclosed which are administered into parotid and submandibular glands in a dose ratio between 1.45 to 1 and 1.7 to 1.

Abstract: Certain aspects of the present invention relate to modified hemoglobin proteins comprising at least one modification (e.g., at the thiol group of an exogenous amino acid residue) for homogenous conjugation of one or more polymeric moieties e.g. polyethylene glycol or derivatives thereof. Also included herein are methods of using such modified proteins and compositions comprising such proteins, e.g. in therapy.

Abstract: A synthesis method for low-racemization impurity liraglutide comprises the following steps: performing synthesis to obtain a propeptide, coupling 2 to 5 peptides comprising Thr-Phe on the propeptide by using a solid-phase synthesis method; further, performing solid-phase synthesis to obtain a liraglutide resin; the liraglutide resin is cracked after modification, or the liraglutide resin is directly cracked, purified and frozen dry, so as to obtain the liraglutide.

Abstract: Solutions comprising a glycopeptide antibiotic, for example Vancomycin, and an amino acid or amino acid derivative such as N-acetyl-Glycine or N-acetyl-D-Alanine are provided. These solutions are stable or stabilized for long-term periods at conditions of normal use and storage, and can be formulated as pharmaceutical solutions for use in subjects. Methods of manufacturing and using these solutions are also provided, as are methods of stabilizing a glycopeptide antibiotic, for example Vancomycin, using amino acids or amino acid derivatives such as N-acetyl-Glycine or N-acetyl-D-Alanine.

Abstract: The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas. The present invention also provides a lyophilized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, a viscosity of up to 3.2 mPas, a and processes for providing this lyophilized degarelix drug substance.

Abstract: Disclosed is a wound treatment that includes collagen and a gelatin-reducing agent. Also disclosed is a wound dressing including a substrate, collagen, and a gelatin-reducing agent. The collagen and gelatin-reducing agent may be present in any suitable a weight ratio relative to one another, such as a weight ratio of about 0.25:1 to about 4:1 with respect to one another. Also disclosed is a method for promoting wound healing including administering collagen and a gelatin-reducing agent to a wound in need of treatment.

Abstract: The disclosure is directed to compounds and methods for preparing purified macrocyclic peptide using “catch-release” methods. These methods comprise reacting a free amino group of a resin-bound linear peptide with an azide- or alkyne-functionalized cap to form a resin-bound capped linear peptide having an azide- or alkyne-functionalized cap; cleaving the capped linear peptide from the resin to form a free capped linear peptide having an azide- or alkyne-functionalized cap; reacting the free capped linear peptide having an azide-functionalized cap with an alkyne-functionalized catch resin, or reacting the free capped linear peptide having an akynyl-functionalized cap with an azide functionalized catch resin, to form a catch-resin bound capped linear peptide; reacting the catch-resin bound capped linear peptide under conditions sufficient to effect macrocyclization of the linear peptide and release of the macrocyclic peptide from the catch resin.

Abstract: Disclosed are a fusion protein comprising a thyrotropin receptor (TSHR) fragment and the use thereof. More specifically, disclosed are a fusion protein comprising a TSHR fragment comprising an extracellular domain of a wild-type TSHR and having a substitution of an amino acid at specific position and an immunoglobulin Fc region or a carboxy-terminal cap (C-CAP), and the use thereof. The fusion protein has improved pharmaceutical efficacy, in-vivo persistence and protein stability and a pharmaceutical composition containing the fusion protein as an active ingredient is useful as a therapeutic agent or diagnostic reagent for the alleviation of Graves' disease and Graves' ophthalmopathy.

Abstract: The invention generally relates to modified glucagon molecules. In certain embodiments, the invention provides a glucagon molecule that includes one or more modified amino acids to result in the glucagon molecule being soluble at a substantially neutral pH and resistant to fibrillation. Modifications may include, for example, phosphorylation or sulfation.

Abstract: The present invention describes the integration of preparative crystallization, crystal separation, crystal washing and freeze-drying processes of insulin and insulin analogues into single continuous process using pressure filtration. The process facilitates time reduction and outlines the novel design of using multiple organic solvent washes and nitrogen gas purging for the removal of imbibed water and achieve final drug substance that meets the quality specifications.

Abstract: A method for treating a cancer comprises administering to a subject in need of such treatment an effective amount of a pharmaceutical composition comprising an anti-cancer agent having at least one secretion modifying region (SMR) peptide from HIV-1 Nef fused to at least one cell-penetrating peptide (CPP) or at least one Clusterin (Clu)-binding peptide (Clu-BP).

Abstract: The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using anion exchange chromatography to produce aflibercept with a specific glycosylation profile. In particular, these methods produce aflibercept with a glycosylation profile with specific ranges of % total fucosylated glycans, total sialylated glycans, mannose-5, and galactosylated glycans.

Abstract: The invention provides a polymyxin compound of formula (I) and salts, solvates and protected forms thereof, pharmaceutical compositions comprising the compounds of formula (I), and the use of the compounds and compositions in methods of treatment, such as methods for the treatment of microbial infections. The compounds of formula (I) are represented thus: wherein —R15 is a group: and —R16 is hydrogen; —R17 is hydrogen -L- is a covalent bond or methylene; and —Ar is optionally substituted aryl. The groups —X—, —R1, —R2, —R3, —R4, and —R8 are as defined herein.

Abstract: The present disclosure pertains to methods for preparing a prefilled syringe and methods for preparing an auto injector prefilled syringe comprising aflibercept and methods for producing such aflibercept in chemically defined media.