Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: The present invention is based, at least in part, on the identification of a pharmaceutical container formed, at least in part, of a glass composition which exhibits a reduced propensity to delaminate, i.e., a reduced propensity to shed glass particulates. As a result, the presently claimed containers are particularly suited for storage of pharmaceutical compositions and, specifically, a pharmaceutical solution comprising a pharmaceutically active ingredient, for example, FORTEO® (recombinant human teriparatide), DULAGLUTIDE® (LY2189265), recombinant insulin glargine, RAMUCIRUMAB® (IMC-1121B), SOLANEZUMAB® (LY2062430), IXEKIZUMAB® (LY2439821), TABALUMAB® (LY2127399), NECITUMUMAB® (IMC-11F8), or CIXUTUMUMAB® (IMC-A12).

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: The present invention relates to the treatment of osteoarthritis and pain using IL-1? and IL-1? binding proteins, including anti-IL-1? and anti-IL-1? antibodies and engineered multivalent and multispecific IL-1? and IL-1? binding proteins.

Abstract: The invention relates to reagents and methods for detecting, diagnosing and screening for conditions associated with hydroxylated hypoxia inducible factor 1-? (HIF-1?). The invention also relates to novel monoclonal antibodies specific for hydroxylated HIF-1?, or binding fragments thereof, and related nucleic acids, vectors, cells and compositions, as well as methods of using the antibodies in methods of the invention.

Abstract: Antibodies that interact with interleukin-1 receptor type 1 (IL-1R1) are described. Methods of treating IL-1 mediated diseases by administering a pharmaceutically effective amount of antibodies to IL-1R1 are described. Methods of detecting the amount of IL-1R1 in a sample using antibodies to IL-1R1 are described.

Abstract: An Fc variant of a parent Fc polypeptide, wherein said Fc variant exhibits altered binding to one or more Fc?Rs, wherein said Fc variant comprises at least one amino acid insertion in the Fc region of said parent Fc polypeptide.

Abstract: Described herein are irreversible Btk inhibitor compounds, and methods for using such irreversible inhibitors in the treatment of diseases and disorders characterized by the presence or development of solid tumors.

Abstract: The present application relates to a variant Fc region comprising at least one modification relative to a wild-type human Fc region, where the modification selected from the group consisting of 434S, 252Y/428L, 252Y/434S, and 428L/434S, and the numbering is according to the EU index.

Abstract: The invention provides methods, uses and compositions for the treatment of ankylosing spondylitis (AS). The invention describes methods and uses for treating ankylosing spondylitis, wherein a TNF? inhibitor, such as a human TNF? antibody, or antigen-binding portion thereof, is used to reduce signs and symptoms of ankylosing spondylitis in a subject. Also described are methods for determining the efficacy of a TNF? inhibitor for treatment of ankylosing spondylitis in a subject.

Abstract: The present invention provides isolated monoclonal antibodies, particularly human monoclonal antibodies, that specifically bind to PD-1 with high affinity. Nucleic acid molecules encoding the antibodies of the invention, expression vectors, host cells and methods for expressing the antibodies of the invention are also provided. Immunoconjugates, bispecific molecules and pharmaceutical compositions comprising the antibodies of the invention are also provided. The invention also provides methods for detecting PD-1, as well as methods for treating various diseases, including cancer and infectious diseases, using anti-PD-1 antibodies. The present invention further provides methods for using a combination immunotherapy, such as the combination of anti-CTLA-4 and anti-PD-1 antibodies, to treat hyperproliferative disease, such as cancer. The invention also provides methods for altering adverse events related to treatment with such antibodies individually.

Abstract: Provided herein is are methods of reducing the number and severity of acute exacerbations of asthma in an asthma patient, comprising administering to a patient with a history of acute exacerbations of asthma an effective amount of an anti-interleukin-5 receptor (IL-5R) antibody or antigen-binding fragment thereof, for example, an anti-IL-5R? antibody or antigen-binding fragment thereof, e.g., benralizumab.

Abstract: The invention provides isolated fully human monoclonal anti-HRV antibodies, as well as method of making and using these antibodies. Anti-HRV antibodies of the invention prevent or treat subjects having HRV-infections, and related diseases, including, but not limited to, the common cold, nasopharyngitis, croup, pneumonia, bronchiolitis, asthma, chronic obstructive pulmonary disease (COPD), sinusitis, bacterial superinfection, and cystic fibrosis.

Abstract: Disclosed are compositions and methods that provide pharmacodynamic effects specific to therapeutic macromolecules. The effects may result from reduced doses of therapeutic macromolecules in combination with immunosuppressant doses. The effects may also be enhanced with such compositions.

Abstract: Disclosed are dosings of therapeutic macromolecules and immunosuppressants, in some embodiments attached to synthetic nanocarriers, in combination with dosings of therapeutic macromolecules without synthetic nanocarriers, and related methods that provide reduced humoral immune responses.

Abstract: The subject invention relates to monoclonal antibodies that may be used in the treatment and diagnosis of Alzheimer's Disease. In particular, the present invention relates to monoclonal antibodies referred to as 10F4 and 3C5 and to other monoclonal antibodies (e.g., murine, human or humanized) having similar properties thereto.

Abstract: The invention relates to antibodies that are reactive to the cell surface of CD19+ B cells, including B-cell chronic lymphocytic leukemia (B-CLL) cells, and compositions and methods for using such antibodies, including in the diagnosis and treatment of disorders associated with CD19+ B cells, such as B-CLL.

Abstract: Specific monoclonal antibodies and fragments including bispecific antibodies thereof that are crossreactive with multiple clades of influenza virus including both Group 1 and Group 2 representatives are disclosed. These antibodies are useful in controlling influenza epidemics and pandemics as well as in providing prophylactic or therapeutic protection against seasonal influenza.

Abstract: The present invention concerns the use of HYD1 peptides to reduce activated T-cell numbers and/or to promote bone preservation in vivo. The present invention concerns methods of treating a bone deficiency and/or an autoimmune disorder, comprising administering an effective amount of a HYD1 peptide. Another aspect of the invention concerns a pharmaceutical composition comprising a HYD1 peptide and another agent for treating a bone deficiency and/or another agent for treating an autoimmune disorder.

Abstract: Disclosed is polynucleotide encoding a polypeptide comprising an antibody binding site, the polypeptide being able to bind to HCV E2 samples representative of each of HCV genotypes 1-6, as well as polypeptides having such properties and uses of such polypeptides in detecting and treating HCV infection.

Abstract: Provided herein are methods of treatment of acute respiratory distress syndrome comprising administration of adrenocorticotropic hormone (ACTH), or fragment, analog, complex or aggregate thereof, or any combination thereof, to an individual in need thereof

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: Disclosed herein are compositions and methods of use comprising hexavalent DNL complexes. Preferably, the complexes comprise anti-CD20 and/or anti-CD22 antibodies or fragments thereof. More preferably, the anti-CD20 antibody is veltuzumab and the anti-CD22 antibody is epratuzumab. Administration of the subject hexavalent DNL complexes induces apoptosis and cell death of target cells in diseases such as B-cell lymphomas or leukemias, autoimmune disease or immune dysfunction disease. In most preferred embodiments, the DNL complexes increase levels of phosphorylated p38 and PTEN, decrease levels of phosphorylated Lyn, Akt, ERK, IKK?/? and I?B?, increase expression of RKIP and Bax and decrease expression of Mcl-1, Bcl-xL, Bcl-2, and phospho-BAD in target cells. The subject DNL complexes show EC50 values for inhibiting tumor cell growth in the low nanomolar or even sub-nanomolar concentration range.

Abstract: The instant invention relates to the field of protein production and in particular to controlled protein heterogeneity compositions and processes for controlling the heterogeneity of proteins expressed in host cells.

Abstract: The present invention relates to antibodies, including fully human monoclonal antibodies, with specificity to GPNMB, and uses of such antibodies. The present invention further provides compositions that increase expression of GPNMB on the surface of tumor cells, and methods of using such compositions to increase the anti-cancer activity or other therapeutic efficacy of the antibodies and immunoconjugates provided herein.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: Compositions for cancer or infection treatment via immunopotentiation caused by inhibition of immunosuppressive signal induced by PD-1, PD-L1, or PD-L2 and therapies using them, immunopotentiative substrates included as the active ingredient, screening methods of the substrates for cancer or infection treatment, cell lines used for the screening methods, evaluation methods that select the substrates for cancer treatment, and carcinoma cell transplanted mammals used for the evaluation methods. The compositions of the present invention that inhibits the function of PD-1, PD-L1, or PD-L2 are useful for treatment of cancer or infection.

Abstract: Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.

Abstract: The present invention provides methods for reducing tumor survival, expansion, and metastasis. In particular, the invention provides methods for reducing pancreatic tumor survival, expansion, and metastasis. The invention also provides agents for use in the methods, particularly agents that reduce the level or activity of connective tissue growth factor (CTGF), and methods for identifying such agents.

Abstract: The disclosure provides methods and compositions for treating cancer cells, including cancer cells in a subject, whereby two or more therapeutic agents are used, one being an EGFR-TKI agent and the other being a synthetic oligonucleotide.

Abstract: The present invention relates to the provision of a novel method for the reconstitution of dry formulations comprising biomolecules, and in particular, to dry protein formulations, and to pharmaceutical or veterinary products suitable for parenteral administration containing reconstituted formulations prepared according to the novel method of the invention.

Abstract: The present invention relates to optimized Fc variants, methods for their generation, and antibodies and Fc fusions comprising optimized Fc variants.

Abstract: The present invention relates to methods of treating diseases or disorders affecting the eye or optic nerve characterized by elevated ?-amyloid levels or ?-amyloid deposits, particularly age related macular degeneration and glaucoma type diseases and ?-amyloid dependent cataract formation, with antigen binding proteins that bind ?-amyloid peptide and in particular human ?-amyloid peptide.

Abstract: The present invention provides methods of using Bv8 and EG-VEGF polypeptides and nucleic acids to promote hematopoiesis. Also provided herein are methods of screening for modulators of Bv8 and EG-VEGF activity. Furthermore, methods of treatment using Bv8 and EG-VEGF polypeptides or Bv8 and EG-VEGF antagonists are provided.

Abstract: The present invention relates to antibodies including human antibodies and antigen-binding portions thereof that specifically bind to ErbB2, preferably human ErbB2. In another embodiment, the antibodies or antigen-binding portions thereof inhibit ErbB2. The invention also relates to antibodies that are chimeric, bispecific, derivatized, single chain antibodies or portions of fusion proteins. The invention also relates to isolated heavy and light chain immunoglobulins or portions thereof derived from human anti-ErbB2 antibodies and nucleic acid molecules encoding such immunoglobulins. The present invention also relates to methods of using the antibodies and compositions for diagnosis and treatment. The invention also provides gene therapy methods using nucleic acid molecules encoding the heavy and/or light immunoglobulin molecules that comprise the human anti-ErbB2 antibodies. The invention also relates to transgenic animals or plants comprising nucleic acid molecules of the present invention.

Abstract: The function of natural killer (NK) cells is regulated by inhibitory and activating signals delivered by cell surface receptors, 1-7F9 is a fully human monoclonal antibody (mAb) directed against KIR2DL1 and K1R2DL2/3 receptors that blocks its interaction with its HLA-C ligands breaking NK cell tolerance to autologous tumor ceils. L?nalidomide has been shown to increase NK cell cytotoxicity in vitro. The combination of lenalidomide and 1-7F9 enhanced NK cell mediated cytotoxicity against U266 cells beyond that observed with each agent alone. Lenalidomide also increased the expression of NKG2D, DNAM-I and TRAIL ligands including: MICA, ULB P2, CD1 12 and DR 4 on U266 cells. In in vitro cytotoxicity assays, lenalidomide enhanced the susceptibility of myeloma cell lines to NK ceil. The NK ceil signaling pathways was also explored after lenalidomide treatment and the results show that lenalidomide may upreguiate the phospho-SHIP1 (Tyr1020) and has no effect on phospho-p44/42 (ERK 1/2) (Thr202/Tyr204) in NK cells.

Abstract: The present invention provides compositions and methods of treating and improving the symptoms of rheumatoid arthritis using an antibody or antigen-binding fragment thereof that specifically binds human interleukin-6 receptor (hIL-6R) with a DMARD.

Abstract: A pharmaceutical composition includes one or more RANK/RANKL antagonists and a pharmaceutically acceptable carrier. The composition can be used for treating neuromuscular disorders, non-genetic myopathies, or genetic myopathies; maintaining and/or preserving the excitation:contraction:relaxation coupling; reducing loss of muscle strength associated with neuromuscular disorders, non-genetic myopathies or genetic myopathies; reducing the loss of muscular strength associated with skeletal or cardiac muscle disuse, diseases and aging; or regulating skeletal or cardiac muscle disuse, diseases and/or aging in a patient in need thereof. Methods are used to identify candidate compounds.

Abstract: Provided are novel human copper-zinc superoxide dismutase, also known as superoxide dismutase 1 or SOD1, specific antibodies as well as fragments, derivatives and variants thereof as well as methods related thereto. Assays, kits, and solid supports related to antibodies specific for SOD1 are also disclosed. The antibody, immunoglobulin chain(s), as well as binding fragments, derivatives and variants thereof can be used in pharmaceutical and diagnostic compositions for SOD1 targeted immunotherapy and diagnosis, respectively.

Abstract: The present invention relates to engineered multivalent and multispecific binding proteins, methods of making, and specifically to their uses in the prevention, diagnosis, and/or treatment of disease.

Abstract: The invention provides the antibody D9.2 and antibody molecules based on D9.2 which bind interleukin-17 receptor B. These may be useful in therapy, e.g. the treatment of asthma, ulcerative colitis or Crohn's disease.

Abstract: A method of treating a cancer with an mTOR inhibitor and an anti-IGF-1 R antibody is disclosed.

Abstract: The present invention relates generally to methods of using anti-NGF antibodies in the treatment of various NGF-related disorders, including pain, asthma, arthritis and psoriasis. The methods are effective in treating these disorders in a patient without having a significant adverse effect on the immune system of the patient.

Abstract: The invention provides anti-LRP6 antibodies and methods of using the same. A particular aspect of the invention provides for bispecific anti-LRP6 antibodies that inhibit signaling by multiple Wnt isoforms.

Abstract: The present invention relates to alkylglycoside-containing compositions and methods for increasing the stability, reducing the aggregation and immunogenicity, increasing the biological activity, and reducing or preventing fibrillar formation of a peptide, polypeptide, or variant thereof, for example parathyroid hormone (PTH) or PTH analogs, amylin, a monoclonal antibody, insulin, Peptide T or analog thereof, gastrin, gastrin releasing peptides, gastrin releasing peptide-like (GRP) proteins, epidermal growth factor or analog thereof.

Abstract: Methods of treating TNF?-related disorders comprising administering TNF? inhibitors, including TNF? antibodies are described.

Abstract: The invention describes methods of treating erosive polyarthritis comprising administering a TNF? antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF? antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.

Abstract: This invention provides novel peptides and methods to prevent, control, and treat an inflammation, cancer and other disorders, particularly of the gastrointestinal tract and the lung by administering at least one agonist of guanalyte cyclase receptor either alone or in combination with a compound selected from i) 5-aminosalicyclic acid (5-ASA) or a derivative or a pharmaceutically acceptable salt thereof; ii) mercaptopurine; or iii) an anti-TNF therapy.

Abstract: The present invention provides isolated human or humanized antibodies or antigen-binding fragments thereof which specifically bind to Growth and Differentiation Factor-8 (GDF8) and block GDF8 activity. The antibodies and antibody fragments of the present invention may be used in therapeutic methods for treating conditions or disorders which are ameliorated or improved by inhibition of GDF8.

Abstract: The present application provides methods for producing human monoclonal antibodies without using hybridoma technology, antibodies produced used the described methods, and methods for using the antibodies to treat or prevent disease conditions (e.g., infection by pathogens such as the Human Immunodeficiency Virus).