Abstract: The invention is directed to compounds of Formula I (I) or their pharmaceutically acceptable salts, which may be suitable for imaging alpha-synuclein pathology and hence are useful in binding and imaging alpha-synuclein aggregates in patients with Parkinson's Disease. More specifically, this invention relates to a method of using the compounds of this invention as tracers in positron emission tomography (PET) imaging to study alpha-synuclein in brain in vivo to allow diagnosis of Parkinson's Disease and other neurodegenerative diseases Specific characterized by alpha-synuclein pathology. The invention further relates to a method of measuring clinical efficacy of therapeutic agents for Parkinson's Disease and other neurodegenerative diseases characterized by alpha-synuclein pathology.

Abstract: The present disclosure is directed to compounds that are blockers of NaV1.7 which have the structure of Formula I: or a pharmaceutically acceptable salt thereof.

Abstract: Disclosed herein are polypeptides and polypeptide complexes that are capable of binding tumor cell antigens and effector cell antigens. In some embodiments, the polypeptides and polypeptide complexes bind the tumor cell antigens and the effector cell antigens in a tumor microenvironment.

Abstract: The disclosure describes methods for measuring the potency of anti-Respiratory Syncytial Virus (RSV) antibody against respiratory syncytial virus in a cell culture system using an RSV reporter virus. The disclosure also describes respiratory syncytial viruses that carry a reporter gene, and expression vectors for producing an infectious recombinant respiratory syncytial virus (RSV) that carry a reporter gene.

Abstract: The present disclosure provides, among other things, a lipid nanoparticle adjuvant composition. The present disclosure provides pharmaceutical compositions that include a stable lipid nanoparticle adjuvant and human papillomavirus (HPV) virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Abstract: The present invention relates to stable formulations comprising antibodies or antigen-binding fragments thereof that bind to respiratory syncytial virus (RSV). Also provided are methods of preventing and/or treating RSV-related diseases with the formulations of the invention.

Abstract: A proximal subassembly for an injection device includes a thumb press, a base housed within the thumb press, and an internal screw at least partially disposed within the base, the internal screw being configured and arranged to rotate when the thumb press is linearly actuated.

Abstract: The present invention is directed to urea compounds of formula(s) which are agonists of orexin receptors. The present invention is also directed to uses of the compounds described herein in the potential treatment or prevention of neurological and psychiatric disorders and diseases in which orexin receptors are involved. The present invention is also directed to compositions comprising these compounds. The present invention is also directed to uses of these compositions in the potential prevention or treatment of such diseases in which orexin receptors are involved.

Abstract: The present invention provides a compound of Formula I wherein R1, R2, R3, R4, R5, R6, R7, and subscripts X and n are as described herein and pharmaceutical compositions comprising one or more said compounds, and methods for using said compounds for the treatment, inhibition, or amelioration of one or more disease states that could benefit from inhibition of a coronavirus, including SARS-CoV, MERS-CoV and SARS-CoV-2. The compounds of this invention could further be used in combination with other therapeutically effective agents, including but not limited to, other drugs useful for the treatment of coronavirus infection. The invention furthermore relates to processes for preparing compounds of Formula I, and pharmaceutical compositions which comprise compounds of Formula I and pharmaceutically acceptable salts thereof.

Abstract: The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by subcutaneous administration.

Abstract: The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant.

Abstract: Disclosed are cyclic peptides, their salts, pharmaceutical compositions comprising them, diagnostic and therapeutic uses and processes for making such compounds, which bind to granzyme B and may be suitable for imaging granzyme B. Further provided are compounds useful as a radiotracer for positron emission tomography (PET) and/or single photon emission tomography (SPECT) imaging. The use of the compounds as imaging agents of granzyme B is further disclosed.

Abstract: The present invention is directed to macrocyclic urea compounds which are agonists of orexin receptors. The present invention is also directed to uses of the compounds described herein in the potential treatment or prevention of neurological and psychiatric disorders and diseases in which orexin receptors are involved. The present invention is also directed to compositions comprising these compounds. The present invention is also directed to uses of these compositions in the potential prevention or treatment of such diseases in which orexin receptors are involved.

Abstract: Novel compounds of the structural Formula (I), and the pharmaceutically acceptable salts thereof are inhibitors of NLRP3 and may be useful in the treatment, prevention, management, amelioration, control and suppression of diseases mediated by NLPR3. The compounds of structural formula I may be useful in the treatment, prevention or management of diseases, disorders and conditions mediated by NLRP3 such as, but not limited to, gout, pseudogout, CAPS, NASH fibrosis, heart failure, idiophathic pericarditis, atopic dermatitis, inflammatory bowel disease, Alzheimer's Disease. Parkinson's Disease and traumatic brain injury.

Abstract: Provided herein are methods for treating a cancer patient with an ROR1 immunoconjugate and a BTK inhibitor. These methods may be useful for the treatment of a variety of cancers that express ROR1 and are expected to be mediated or modulated by BTK signaling.

Abstract: The present invention provides a compound of Formula (I) and pharmaceutical compositions comprising one or more said compounds, and methods for using said compounds for treating or preventing one or more disease states that could benefit from inhibition of plasma kallikrein, including hereditary angioedema, uveitis, posterior uveitis, wet age related macular edema, diabetic macular edema, diabetic retinopathy and retinal vein occlusion. The compounds are selective inhibitors of plasma kallikrein.

Abstract: The present invention relates to compounds of Formula (I): and pharmaceutically acceptable salts or prodrug thereof. The present invention also relates to compositions comprising at least one compound of Formula (I), and methods of using the compounds of Formula (I) for treatment or prophylaxis of lysosomal storage diseases, neurodegenerative disease, cystic disease, cancer, or a diseases or disorders associated with elevated levels of glucosylceramide (GlcCer), glucosylsphingosine (GlcSph) and/or other glucosylceramide-based glycosphingolipids (GSLs).

Abstract: Provided are compounds of Formula I, Formula Ib or Formula Ic and the pharmaceutically acceptable salts, esters, and prodrugs thereof, which are DGAT2 inhibitors. Also provided are methods of making compounds of Formula I, Formula Ib or Formula Ic, pharmaceutical compositions comprising compounds of Formula I, Formula Ib or Formula Ic, and methods of using these compounds to treat hepatic steatosis, non-alcoholic steatohepatitis (NASH), fibrosis, type-2 diabetes mellitus, obesity, hyperlipidemia, hypercholesterolemia, atherosclerosis, cognitive decline, dementia, cardiorenal diseases such as chronic kidney diseases and heart failure and related diseases and conditions, comprising administering a compound of Formula I to a patient in need thereof.

Abstract: The present disclosure is directed to methods for making compounds of structural formula (I): (I), wherein PG is defined above herein, which are useful for making antibody-drug conjugates. The present disclosure is also directed to processes for making related payload compounds, related Linker-Payload compounds, and to compounds that are useful as synthetic intermediates for making the compounds of formula (I).

Abstract: The invention provides methods for producing high concentration crystalline drug substances of an anti-PD-1 mono-clonal antibody (mAb), wherein the mAb is pembrolizumab or a pembrolizumab variant. The invention further relates to pharmaceutical compositions comprising the crystals produced by the methods herein and methods of use thereof.