Abstract: The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention are in the form of a bead and comprise (i) an inert core; (ii) a first layer surrounding the inert core, wherein the first layer comprises dimethyl fumarate; and (iii) an enteric coating surrounding the first layer. Also provided are pharmaceutical compositions in the form of a bead comprising a core and an enteric coating surrounding the core, wherein the core comprises dimethyl fumarate. Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

Abstract: A device that regulates, monitors, and provides data on the progress of a large-volume injector during its injection sequence. The device comprises an injector and a monitor assembly. The injector has a syringe having a plunger, and a biasing device that biases the plunger through the syringe. The monitor assembly comprises a resistance unit configured to resist movement of the plunger, a gear connected to the plunger by the resistance unit, and a control unit configured to monitor the position, and regulate the rotation, of the gear. Wherein linear movement of the plunger causes the gear to rotate so that the control unit generates information on the position of the plunger.

Abstract: The present invention provides compounds and compositions thereof which are useful as inhibitors of Bruton's tyrosine kinase and which exhibit desirable characteristics for the same.

Abstract: Provided are compounds of Formulas (I?), (I), (II?) and (II), or pharmaceutically acceptable salts thereof, and methods for their use and production.

Abstract: The present invention pertains to a cell culture medium comprising manganese as a media supplement, which was shown to control recombinant protein glycosylation and methods of using thereof. The present invention further pertains to a method of controlling or manipulating glycosylation of a recombinant protein of interest in a large scale cell culture.

Abstract: Aspect of the disclosure relate to methods of assessing a bioreactor culture that involve determining a culture parameter of the manufacturing-scale bioreactor culture using a model that relates a Raman spectrum to the culture parameter. Related bioreactor system are also provided.

Abstract: Various embodiments of medical detector systems as well as their methods of operation are disclosed. In one embodiment, one or more detectors are coupled to wearable structures for detecting at least a first tracer within a body portion. In another embodiment, one or more detectors are coupled to a wearable structure, where the detector corresponds to a CMOS chip that directly detects a first radioactive tracer.

Abstract: The invention herein describes a solid-phase synthetic method for preparing thiolated oligonucleotides without needing a capping step. The methods of the invention comprises repetition of a three-reaction per cycle, namely detritylation, coupling and sulfurization, without a capping step. In some embodiments, the synthetic methods of the present invention can be used for preparing an anti-sense oligonucleotide.

Abstract: The present invention relates to molecular signatures that can be used to identify patients diagnosed with an autoimmune disease, in particular with systemic lupus erythematosus for treatment with a CD40 or CD40L antagonist such as anti-CD40 antibody, anti-CD40L antibody or a binding fragment thereof. The signatures can also be used to monitor target engagement and response to treatment.

Abstract: Aspects of the invention are directed to arginine-free polypeptide-containing compositions and methods for treating disorders associated with inflammation or the autoimmune response. In particular, the polypeptide is etanercept.

Abstract: Aspects of the application relate to compositions and methods for treating spinal muscular atrophy in a subject. In particular, this application provides therapeutic combinations of a recombinant nucleic acid that encodes the survival of motor neuron 1 (SMN1) protein (e.g., in a viral vector), and an antisense oligonucleotide (ASO) that increases full-length survival of motor neuron 2 (SMN2) mRNA (e.g., that is targeted to a nucleic acid molecule encoding the survival of motor neuron 2 (SMN2) and that promotes the inclusion of exon 7 in SMN2 mRNA).

Abstract: This disclosure provides anti-HSPA5 antibodies. Also featured is a method for delivering an agent into the brain, spinal cord, or other component of the central nervous system. In addition, methods of identifying a human subject at risk of relapse of neuromyelitis optica (NMO) or neuropsychiatric systemic lupus erythematosus (NP-SLE) are disclosed, as are methods of determining the severity of an attack of NMO or NP-SLE, and methods of diagnosing NP-SLE.

Abstract: Provided herein are methods of treating multiple sclerosis with a fumarate, wherein the fumarate is a dialkyl fumarate, a monoalkyl fumarate, a combination of a dialkyl fumarate and a monoalkyl fumarate, a prodrug of monoalkyl fumarate, a deuterated form of any of the foregoing, or a pharmaceutically acceptable salt, clathrate, solvate, tautomer, or stereoisomer of any of the foregoing, or a combination of any of the foregoing. The methods provided herein improve the safety of treatment by informing and monitoring patients undergoing treatment regarding progressive multifocal leukoencephalopathy, and/or by monitoring lymphocyte count.

Abstract: The present invention pertains to methods of producing polypeptide of interest in cell cultures lacking glutamine. The present invention further pertains to a method of producing a protein of interest in a large scale cell culture, comprising supplementing the cell culture with nucleic acid synthesis precursors and/or corticosteroids.

Abstract: A device that prevents the accidental activation and lockout of an autoinjector. In illustrative embodiments, a resistance unit is configured to resist deployment of the needle until a critical force is applied by the user to the autoinjector, at which point, the resistance of the resistance unit is overcome. Continuous application of force by the user after the resistance is overcome drives the delivery device to the injection site where the medication is administered.

Abstract: This invention provides antibodies that recognize the B Cell Maturation Antigen (BCMA) and that bind naïve B cells, plasma cells, and/or memory B cells. The invention further provides methods for depleting naïve B cells, plasma cells, and memory B cells, and for treating B cell-related disorders, including lymphomas and autoimmune diseases.

Abstract: Various aspects and embodiments of the present disclosure relate to the purification antibodies by hydrophobic interaction chromatography under no-salt conditions.

Abstract: Methods and compositions for enhancing one or more of: myelination, re-myelination, oligodendrocyte numbers, or neuroaxonal protection, while ameliorating an inflammatory condition in a human subject are disclosed. In certain embodiments, the methods and compositions described herein include a reparative agent (e.g., a LINGO-1 antagonist) and an immunomodulatory agent, in combination. Thus, methods, compositions and kits described herein can be useful for treating a CNS demyelinating disease.

Abstract: A method for operating a control system for controlling a lighting system. The control system includes at least two lighting control modules, each lighting control module including at least one digital processor and at least one digital memory for generating, managing and storing lighting programs. Each lighting control module includes a housing in which the digital processor and the digital memory are disposed. Digital adjusting commands are generated in each lighting control module, and are transmittable to the lighting devices of the lighting system via data links. The different lighting control modules are able to exchange data via data lines and interfaces. A system time signal is generated in a lighting control module and is transmitted to all lighting control modules of the control system via the data lines, and the lighting programs in the different lighting control modules are executed using the system time signal.