The disclosure provides for a polynucleotide molecule encoding an antibody protein product, wherein the polynucleotide molecule comprises i) a nucleotide sequence specific for the addition of a molecular barcode by a template switching reverse transcriptase (RT) and a unique molecular identifier (UMI) barcode, and a nucleotide sequence specific for a universal RT primer to facilitate high throughput sequencing.
Provided herein are suspensions for oral administration comprising a) apremilast, b) a suspending agent, c) a sweetener, d) one or more of a vehicle, a co-solvent, a buffering agent, a preservative, or a combination thereof. Also provided herein is a suspension for oral administration comprising a) apremilast, b) microcrystalline cellulose/carboxymethylcellulose sodium, c) xanthan gum, d) sucrose, e) sorbitol, f) glycerin, g) propylene glycol, h) citric acid monohydrate, i) methylparaben, j) propylparaben, and h) water.
The present invention relates to a chromatography equilibration method that accelerates equilibration dynamics and reduces the consumption of equilibration solution through a bolus addition of a buffering/titrating agent for on-column titration. The method is particularly useful as a component in a chromatography medium cleaning process.
B01D 15/20 - Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
G01N 30/50 - Conditioning of the sorbent material or stationary liquid
A drug delivery device includes a housing defining a shell having a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, a needle assembly at least partially disposed within the housing at the proximal end, a drive assembly at least partially disposed within the housing and operably coupled to the needle assembly, and an audible indicator operably coupled to the drive assembly. The needle assembly includes a syringe containing a medicament and a needle or a cannula. The drive assembly is movable between an initial position and a second position that results in the medicament being expelled from the syringe. Upon the drive assembly being positioned in the second position, the audible indicator engages the drive assembly to generate an audible sound indicating the medicament has been expelled from the syringe.
The present disclosure provides compounds useful for the inhibition of KRAS G12D. The compounds have a general Formula (I): wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.
The present disclosure provides compounds useful for the inhibition of KRAS G12D. The compounds have a general Formula (I): wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.
C07D 519/00 - Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups or
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
A61K 31/55 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
The present disclosure, relates, in general, to methods of treating asthma, including severe asthma and eosinophilic asthma, using an antibody specific for thymic stromal lymphopoietin (TSLP).
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
7.
VECTORS INCORPORATING A COMBINATION OF PROMOTERS DRIVING SELECTABLE MARKER EXPRESSION
Dual vector systems, and mammalian host cells comprising them, for the expression of multi chain molecules are provided where each vector employs a different promoter driving the expression of a selectable marker. The mammalian host cells can be used for producing a recombinant protein of interest in a mammalian cell culture.
C07K 16/00 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies
C07K 16/12 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from bacteria
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 16/32 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products from oncogenes
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
C07K 16/44 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere
Dual vector systems, and mammalian host cells comprising them, for the expression of multi chain molecules are provided where each vector employs a different promoter driving the expression of a selectable marker. The mammalian host cells can be used for producing a recombinant protein of interest in a mammalian cell culture.
A method of manufacturing a plunger of a drug delivery device includes forming a plunger body. The method includes loading the plunger body into a cavity of a first molding tool of a molding system. The cavity is at least partially defined by a first molding portion and a second molding portion. The method includes coupling a second molding tool to the first molding tool to form a plurality of channels defined by grooves in the first and second molding tools, and injecting molten plastic into the plurality of channels to form an overmolded plunger body. The overmolded plunger body includes a head coupled to the first end of the plunger body and a foot coupled to the second end of the plunger body. The foot is at least partially coupled to the inner wall and the head is coupled to the outer wall of the plunger body.
B29C 45/14 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
B29K 705/00 - Use of metals, their alloys or their compounds, for preformed parts, e.g. for inserts
Monitoring systems for an injection device or simulated injection device and related methods are disclosed. A monitoring system may include: a force sensor configured to output a force signal when a user applies a force to a plunger to operate the injection device or simulated injection device to perform or simulate a drug injection; an end-of-injection sensor configured to output an end-of-injection signal when the user moves the plunger with respect to the drug container from an initial position to a final position during operation of the injection device or simulated injection device; and/or a torque sensor configured to output a torque signal. The monitoring system may further include a computing unit configured to determine from any one or combination of the force signal, end-of-injection signal, and torque signal one or more parameters relating to the user's preparation and/or operation of the injection device or simulated injection device.
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
A61M 5/48 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests having means for varying, regulating, indicating or limiting injection pressure
G09B 23/28 - Models for scientific, medical, or mathematical purposes, e.g. full-sized device for demonstration purposes for medicine
The present disclosure provides materials and methods for preparing a buffer for a therapeutic protein formulation comprising (a) combining a calcium salt, an organic acid and a disaccharide at a temperature equal to or greater than 22 °C to produce an admixture, and (b) adding sodium hydroxide to the admixture of (a) by bolus addition.
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Providing medical information and patient support services,
namely, providing medical information in the fields of
pharmaceuticals and the treatment of various illnesses and
disorders.
13.
SYSTEMS AND APPROACHES FOR DRUG PROCESSING USING SINGLE-USE HARDWARE
A system for dispensing, inspecting, and/or processing drug includes a tray adapted to be operably coupled with a workstation, a handle member operably coupled with the tray, and a funnel region operably coupled with the tray. The tray has a body defining a recessed region and a sidewall positioned adjacent to the recessed region. The handle member is positioned at or near a first corner of the tray. The funnel region is positioned at or near a second corner of the tray. The first corner is opposite the second corner.
A testing system for a drug delivery device includes a frame member having first and second ends, a driving member positioned near the frame member, a surrogate syringe barrel operably coupled with the frame member, a flange extender adapted to couple with a portion of the surrogate syringe barrel, and a plunger rod adapted to couple with the flange extender and be at least partially disposed within the surrogate syringe barrel while being movable therein. The driving member is movable in an axial direction between the first end and the second end of the frame member. The plunger rod includes first and second ends and a longitudinal length therebetween, the first end being positioned near a portion of the driving member. The driving member measures a maximum urging force exerted on the plunger rod when moving in the axial direction towards the second end of the frame member.
The present invention relates to a combination of Alternating Tangential Flow (ATF) filtration and Recirculating Tangential Flow (RTF) filtration as an Alternating Recirculating Tangential Flow (ARTF) filtration that overcomes processing challenges observed with either ATF or FTF filtration alone. ARTF filtration is sued to achieve a means of media perfusion or harvesting of desired product as part of a cell culture bioreactor process development.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations and substances for the treatment of cancer and cardiovascular diseases and disorders; pharmaceutical preparations and substances for the treatment of oncological diseases and disorders; pharmaceutical preparations for the treatment of gastric and gastro-esophageal diseases, conditions or maladies; other pharmaceutical preparations
Provided herein are T-cell receptors (TCRs) that when expressed recombinantly on the surface of a T cell are able to recognize the DCAF4L2-derived peptide ILQDGQFLV (SEQ ID NO:1) when presented by HLA-A*02:01 sufficiently to activate the recombinant T cell. Importantly, exemplary TCRs provided herein were thoroughly screened for lack of cross-reactivity with similar peptides that may be presented by normal cells or tissue and for alloreactivity.
The present invention relates to compositions and methods for enhancing the gene silencing activity of oligonucleotide compounds. In particular, the invention relates to inhibiting the expression or activity of suppressor proteins, such as RAB18, ZW10, STX18, SCFD2, NAPG, SAMD4B, or VPS37A, to increase the efficacy of ligand-conjugated oligonucleotide compounds in reducing the expression of target genes in a cell.
A method of placing a plunger into a syringe barrel filled with a drug product. The method includes aligning a stopper with a longitudinal axis of a syringe barrel. The syringe barrel includes a proximal end, a distal end, and a reservoir. The drug product is disposed in the reservoir at the distal end. The method includes applying a vacuum pressure to the reservoir of the syringe barrel. The method includes pushing the stopper with a plunger rod into the reservoir of the syringe barrel to a first depth. The method includes removing the plunger rod from the reservoir of the syringe barrel after pushing the stopper to the first depth. The stopper migrates to a second depth that is different than the first depth in response to a pressure differential in the reservoir of the syringe barrel.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Injectors for medical purposes pre-filled with
pharmaceutical preparations for treating cancer, immune,
cardiovascular, metabolic and inflammatory diseases and
conditions.
21.
CELLULAR ASSAYS TO QUANTIFY TARGET-INDEPENDENT CLEARANCE OF THERAPEUTIC MOLECULES
This application relates to the facilitation of selective binding between modified VH and VL domains by introducing amino acids of complementary charges in the two domains at novel locations within these domains. These alterations are particularly useful in designing and generating multispecific antibodies, such as bispecific antibodies, in which the charge pair mutations in VH and VL domains can facilitate desired pairing between particular heavy and light chain polypeptides. These charge pair mutations can be used on their own, or in combination with additional strategies to promote correct pairing of polypeptide chains.
A drug delivery device includes a housing having proximal and distal ends and a longitudinal axis extending therebetween, an injection assembly at least partially disposed within the housing at or near the proximal end, a shield slidably coupled with the housing, a drive assembly operably coupled with the injection assembly and the shield, and a cap. The injection assembly includes a needle or a cannula. The shield is positionable in an extended position in which at least a proximal end thereof extends a distance beyond the proximal end of the housing. The drive assembly is engageable to deliver a medicament via the injection assembly. The cap is removably coupled with at least one of the shield or the housing and is adapted to limit movement of the shield when coupled with the shield and/or the housing such that the drive assembly is restricted from delivering the medicament via the injection assembly.
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
24.
METHODS FOR CHROMATOGRAPHY AND CHROMATOGRAPHY MEDIUM REUSE
Disclosed herein are methods for chromatography, including cleaning methods for chromatography medium that make use of a linear salt gradient. The disclosed methods may be used for frontal chromatography operations and for cleaning frontal chromatography media for reuse in biologics manufacturing.
Disclosed herein are methods for chromatography, including cleaning methods for chromatography medium that make use of a linear salt gradient. The disclosed methods may be used for frontal chromatography operations and for cleaning frontal chromatography media for reuse in biologics manufacturing.
26.
METHODS AND SYSTEMS FOR DETERMINING AN IMPACT OF ATTRIBUTES
A computer-implemented method for determining a correlation status associated with a clinical impact of one or more material attributes, the method comprising: obtaining, via one or more processors, material attribute data of the one or more material attributes associated with a pharmaceutical material, wherein the material attribute data comprises measurement data of the one or more material attributes at one or more timepoints; obtaining, via the one or more processors, clinical data associated with the pharmaceutical material, wherein the clinical data comprises subject data including one or more clinical events associated with one or more subjects that have received an administration of the pharmaceutical material; applying, via the one or more processors, one or more transformations to the material attribute data and the clinical data to create modified material attribute data and modified clinical data, wherein the one or more transformations comprise at least one of cleaning, merging, associating, selecting, or grouping; and determining, via the one or more processors, the correlation status based on the modified material attribute data and the modified clinical data using a computational model.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
27.
MYOPEPTIDES AND METHODS OF USE IN TREATING HEART FAILURE
Myopeptides are provided, which include a myosin S2 fragment having at least 90% sequence identity to an amino acid sequence consisting of VKEMTERLEDEEEMNAELTAKK (SEQ ID NO: 1); and, optionally, a cardiac-homing peptide tag. Also provided are pharmaceutical compositions and methods of use of the myopeptides and pharmaceutical compositions in the treatment of heart failure.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
A61K 9/00 - Medicinal preparations characterised by special physical form
Methods of selecting or rejecting a specification target range for a product quality attribute of a pharmaceutical product are described herein. Methods of manufacturing a pharmaceutical product are described herein. Methods of assessing an impact of a product quality attribute of a pharmaceutical product are described herein.
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
G06Q 10/0639 - Performance analysis of employeesPerformance analysis of enterprise or organisation operations
G16H 70/40 - ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
29.
APPLICATION OF NATURAL LANGUAGE PROCESSING TO FACILITATE RESPONSES TO REGULATORY QUESTIONS
In systems and methods for processing regulatory questions, textual data representing regulatory questions is obtained by one or more processors. The systems and methods also use one or more natural language processing models to classify the regulatory questions, generate answers to the regulatory questions, generate summaries of the regulatory questions, and/or identify documents that are similar to the regulatory questions. The systems and methods also store, transmit, and/or display data indicative of the classifications, answers, summaries, and/or similar documents.
Protein formulations and methods of making and using such formulations are provided herein. The formulation can be an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the formulation comprises a VEGFR-Fc fusion protein, such as aflibercept. In some embodiments, the formulation comprises a Tris buffer.
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
The present invention relates to T cell engager masking molecules, and methods related thereto, that reduce the severity of cytokine release syndrome, wherein said molecules have (i.) a binding peptide which binds to a T-cell engaging paratope of a bispecific T cell engager molecule (TCE), (ii.) a linker, and (iii.) a half- life extending polymer.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
The present disclosure provides compounds useful for the inhibition of KRAS G12D. The compounds have a general Formula I: wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.
The present disclosure provides compounds useful for the inhibition of KRAS G12D. The compounds have a general Formula I: wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.
C07D 519/00 - Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups or
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
A61K 31/5377 - 1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
A61K 31/553 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and at least one oxygen as ring hetero atoms, e.g. loxapine, staurosporine
33.
AFLIBERCEPT ATTRIBUTES AND METHODS OF CHARACTERIZING AND MODIFYING THEREOF
The present disclosure relates to aflibercept, in particular, attributes of aflibercept. Also provided herein are methods of characterizing and modifying the attributes of aflibercept and compositions comprising aflibercept with particular attributes.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a general Formula (A).
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a general Formula (A).
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a general Formula (A).
Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula (A).
C07D 519/00 - Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups or
A61K 31/437 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
A61P 1/04 - Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
37.
CHARACTERIZATION APPARATUS FOR DRUG DELIVERY DEVICES OR SUBCOMPONENTS THEREOF
Apparatuses, systems and methods are provided that characterize a rear sub-assembly for an autoinjector (AI). Apparatuses, systems and methods are also provided that generate injection time (IT) models for autoinjectors (AIs). Autoinjectors (AIs) (e.g., mechanical AIs, spring-loaded AIs, etc.), components for use within AIs (e.g., prefilled syringes (PFS), rear sub-assemblies (RSAs), etc.), and related methods may utilize mathematical modeling along with design for six sigma (DFSS) and design for reliability and manufacturability (DRM) to establish upstream controls that ensure injection time (IT) robustness of mechanical autoinjectors (AIs). For example, break-loose and extrusion (BLE) alert limit, rear sub-assembly (RSA) area under the curve (AUC), and RSA minimum force.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
G01L 5/00 - Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
VEGFR-Fc fusion protein formulations and methods of making using such formulations are provided herein. In one embodiment, the formulation is an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the VEGFR-Fc fusion protein is aflibercept.
A61K 31/505 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/53 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
A61K 31/5355 - Non-condensed oxazines containing further heterocyclic rings
A61K 39/00 - Medicinal preparations containing antigens or antibodies
The invention relates to the treatment of bone disorders. In particular, the invention provides an approach involving administration of a high initial dose or doses of an sclerostin antibody to bring about a rapid increase in bone formation, followed by administration of lowers doses of the antibody to give a sustained lower rate of bone formation after the initial burst of bone formation. The invention also provides an approach involving decreasing dosing frequency with such an antibody to control bone formation. The approaches may be used in particular in those subjects who would benefit most from such an initial rapid burst of bone formation. Examples of such subjects include subjects who have been recently diagnosed or are experiencing severe symptoms of the disorder, as well as those subjects who have been administered a different treatment for the bone disorder which is proving ineffective. The approaches may be used in combination with each other.
Systems, and methods that facilitate the performance of an assay of a sample substantially in real-time. Thus, the assay can be performed, and the desired result obtained, much more quickly than allowed by conventional systems and methods.
The present invention relates to a bispecific antibody construct comprising a first binding domain which binds to human MSLN on the surface of a target cell and a second binding domain which binds to human CD3 on the surface of a T cell. Moreover, the invention provides a polynucleotide encoding the antibody construct, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or vector. Furthermore, the invention provides a process for the production of the antibody construct of the invention, a medical use of said antibody construct and a kit comprising said antibody construct.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
Provided herein are amorphous solid dispersions comprising sotorasib in an amorphous form and a matrix polymer. Also provided herein are processes for preparing the disclosed amorphous solid dispersions and pharmaceutical compositions comprising and methods of using the disclosed amorphous solid dispersions.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations and substances for the treatment of cancer and cardiovascular diseases and disorders; pharmaceutical preparations and substances for the treatment of oncological diseases and disorders; pharmaceutical preparations for the treatment of gastric and gastro-esophageal diseases, conditions or maladies; other pharmaceutical preparations
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations and substances for the treatment of cancer and cardiovascular diseases and disorders; pharmaceutical preparations and substances for the treatment of oncological diseases and disorders; pharmaceutical preparations for the treatment of gastric and gastro-esophageal diseases, conditions or maladies; other pharmaceutical preparations
46.
IMPACT ACTIVATED RETENTION FEATURE FOR DRUG DELIVERY DEVICE
A drug delivery device includes a housing having proximal and distal ends and a longitudinal axis extending therebetween, an injection assembly at least partially disposed within the housing including a needle or a cannula, a drive assembly operably coupled with the injection assembly, a shield slidably coupled with the housing and operably coupled with the drive assembly, and a retention mechanism. The drive assembly is engageable to deliver a medicament via the injection assembly. The shield is positionable in an extended position in which at least a proximal end extends a distance beyond the proximal end of the housing and a retracted position where the proximal end of the housing protrudes a distance beyond the proximal end of the shield. Moving the shield to the retracted position engages the drive assembly to deliver the medicament via the injection assembly. The retention mechanism limits movement of the drive assembly to restrict engagement thereof such that the drive assembly is restricted from delivering the medicament via the injection assembly.
Drug delivery devices and related arrangements are disclosed. A drug delivery device may include a housing having an opening, a drug storage container including a delivery member with an insertion end configured to extend at least partially through the opening, and a plunger. A drive mechanism may be included for driving the plunger in a distal direction to expel a drug from the drug storage container through the delivery member upon activation. The drug delivery device may additionally include a guard moveably disposed adjacent to the opening and operably coupled to the drive mechanism for activation of the drive mechanism. A lock may be selectively engageable with the guard to limit movement of the guard in the proximal direction. An indicator may be coupled to the drive mechanism to generate an audible signal during drug delivery, and to cease generating the audible signal when drug delivery is complete.
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
C12N 5/071 - Vertebrate cells or tissues, e.g. human cells or tissues
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A method for reducing material usage in vessels is provided. The method includes obtaining historical fill weight data indicating actual, per-unit fill weight volumes for a plurality of vessels. The method also includes generating, based on analysis of the historical fill weight data, a distribution of simulated fill weights. The method further includes randomly sampling the distribution of simulated fill weights to select a subset of the simulated fill weights, and performing a quality check on the subset of the simulated fill weights. The method yet further includes generating a modified distribution of simulated fill weights at least by removing, from the distribution of simulated fill weights, samples of the subset that failed the quality check. The method also includes converting the modified distribution of simulated fill weights to a distribution of fill volumes, and calculating a distribution of deliverable volumes based on the distribution of fill volumes.
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
An insertion mechanism for a drug delivery device including a trocar, a housing, and a manifold in fluid communication with a fluid pathway connector and movable relative to the housing between a first manifold position adjacent to a proximal end of the housing and a second manifold position adjacent to a distal end of the housing. A hub carrying the trocar or hollow delivery needle is removably connected to the manifold, the hub being movable relative to the housing between a first hub position adjacent to the proximal end of the housing and a second hub position adjacent to the distal end of the housing. A power source is configured to generate rotational motion. A motion conversion mechanism operatively connects the power source and the hub, and is configured to convert the rotational motion into linear motion of the hub.
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Providing medical information and patient support services, namely, providing medical information in the fields of pharmaceuticals and the treatment of various illnesses and disorders.
42 - Scientific, technological and industrial services, research and design
Goods & Services
Research and development of pharmaceutical preparations; research and development of pharmaceutical preparations in the field of weight reduction, long term weight loss management, and diabetes; medical and scientific research information in clinical trials in the field of weight reduction, long term weight loss management, and diabetes; providing websites featuring medical and scientific research information about the diagnostic, prophylactic and therapeutic properties of pharmaceuticals in the field of weight reduction, long term weight loss management, and diabetes; providing websites featuring medical and scientific research information about pharmaceuticals preparations in the field of weight reduction, long term weight loss management, and diabetes; providing websites that features non-downloadable computer software that enables users to access, manage, update and display electronic databases in the field of weight reduction, long term weight loss management, and diabetes
Antibody formulations and methods of making and using such formulations are provided herein. The formulation can be for intravenous administration. In some embodiments, the formulation is for subcutaneous administration. In some embodiments, the formulation comprises an anti-C5 antibody, such as eculizumab.
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a general Formula (A): Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula (A).
A61P 29/02 - Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agentsNon-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
C07D 409/04 - Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 409/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing three or more hetero rings
C07D 417/04 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 417/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing three or more hetero rings
55.
6,6-FUSED BICYCLIC AMIDES AND COMPOSITIONS FOR USE AS 15-PROSTAGLANDIN DEHYDROGENASE MODULATORS
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a structure of Formula (I): or a pharmaceutically acceptable salt thereof; wherein is Formula (i) or Formula (ii) Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula (I).
A61P 29/02 - Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agentsNon-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
C07D 403/04 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 405/14 - Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing three or more hetero rings
56.
Damper Overfill Chamber to Increase Functional Robustness Regarding Variance in Parts and Processes
A damper mechanism for a drug delivery device comprising a frame member, a damper member operably coupled to a drive assembly of the drug delivery device, a damper fluid chamber formed between at least a portion of the frame member and the damper member, and a damper fluid disposed within the damper fluid chamber. The frame member and the damper member rotate relative to each other, and the damper fluid exerts an opposing force on at least one of the frame member and the damper member. The damper fluid chamber includes a main section and an overfill section. The overfill section receives excess damper fluid from the main section to reduce an effect a variation in fill level in the damper fluid chamber has on the opposing force exerted on at least one of the frame member or the damper member.
The present disclosure provides novel 15-hydroxy-prostaglandin dehydrogenase inhibitors, pharmaceutical compositions comprising such compounds, and methods of using such compounds and compositions in treating 15-hydroxy-prostaglandin dehydrogenase-mediated disease. Also provided are methods of making such compounds and intermediates thereof. The compounds have a structure of Formula (I). Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula (I).
A61P 29/02 - Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agentsNon-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
C07D 409/04 - Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 409/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having sulfur atoms as the only ring hetero atoms containing three or more hetero rings
C07D 403/04 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 405/14 - Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing three or more hetero rings
CONFIGURABLE HANDHELD BIOLOGICAL ANALYZERS FOR IDENTIFICATION OF BIOLOGICAL PRODUCTS BASED ON RAMAN SPECTROSCOPY USING ENSEMBLE ARTIFICIAL INTELLIGENCE
Configurable handheld biological analyzers and related biological analytics methods are described for identification of biological products based on Raman spectroscopy using ensemble artificial intelligence (AI). A biological classification ensemble model configuration is loaded into a computer memory of a configurable handheld biological analyzer having a processor and a scanner. The biological ensemble classification model configuration includes a biological classification ensemble model having an unsupervised model and a supervised model. The biological classification ensemble model configured to receive a Raman-based spectra dataset defining a biological product sample as scanned by the scanner. A spectral preprocessing algorithm is executed to reduce a spectral variance of the Raman-based spectra dataset. The biological ensemble classification model identifies a biological product type based on the first Raman-based spectra dataset.
An injection device is provided, including a syringe having a barrel and a flange and a backstop configured to be coupled with the syringe adjacent to the flange. The backstop includes an inner surface generally extending around at least a portion of the syringe, wherein the inner surface includes at least one protrusion extending away from the inner surface and configured to engage the flange and/or the barrel to permit or promote airflow through a space between the inner surface and the syringe.
A61K 38/17 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular wayAccessories therefor, e.g. filling or cleaning devices, arm rests
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
62.
CONFIGURABLE HANDHELD BIOLOGICAL ANALYZERS FOR IDENTIFICATION OF BIOLOGICAL PRODUCTS BASED ON RAMAN SPECTROSCOPY USING ARTIFICIAL INTELLIGENCE
Configurable handheld biological analyzers and related biological analytics methods are described for identification of biological products based on Raman spectroscopy using ensemble artificial intelligence (Al). A biological classification ensemble model configuration (103) is loaded into a computer memory (108) of a configurable handheld biological analyzer (102) having a processor (110) and a scanner (106). The biological ensemble classification model configuration includes a biological classification ensemble model having an unsupervised model and a supervised model. The processor is configured to receive a Raman-based spectra dataset defining a biological product sample as scanned by the scanner and to execute a spectral preprocessing algorithm of the biological ensemble classification model configuration to reduce a spectral variance of the Raman-based spectra dataset. The biological ensemble classification model identifies a biological product type based on the Raman-based spectra dataset.
Disclosed herein are accelerated methods of preparing lyophilized formulations comprising a protein, such as an antibody or a bispecific antigen-binding molecule that exhibit improved storage stability.
Described herein are compositions and methods related to antigen binding proteins that bind to human ST2, including antibodies. In particular embodiments, the disclosure provides fully human anti-ST2 antibodies and deriviatives and variants thereof. Further provided are nucleic acids encoding such antibodies and antibody fragments, variants, and derivatives. Also, provided are methods of making and using such antibodies including methods of treating and preventing autoimmune and inflammatory disorders.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
C12N 15/11 - DNA or RNA fragmentsModified forms thereof
Constructs comprising GDF15, and mutants thereof are provided. In various embodiments the constructs comprising GDF15, and mutants thereof, can be of use in the treatment or ameliorating a metabolic disorder. In various embodiments the metabolic disease or disorder is type 2 diabetes, obesity, dyslipidemia, elevated glucose levels, elevated insulin levels and diabetic nephropathy.
The present disclosure provides compounds having activity as inhibitors of the G12C mutant KRAS protein, pharmaceutical compositions comprising the compounds, and methods of treating certain disorders, such as cancer, including but not limited to lung cancer, pancreatic cancer, colorectal cancer, and solid tumors. In particular, the disclosure provides compounds of Formula (II):, and pharmaceutically acceptable salts thereof, wherein the substituents are as described.
C07D 401/14 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
16 - Paper, cardboard and goods made from these materials
41 - Education, entertainment, sporting and cultural services
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Printed educational materials in the cardiovascular field. Online non-downloadable educational materials in the
cardiovascular field (Term considered too vague by the
International Bureau pursuant to Rule 13 (2) (b) of the
Regulations); providing on-line non-downloadable
publications in the nature of newsletters, brochures, books
and magazines in the cardiovascular field; educational
services, namely, conducting informal on-line programs in
the cardiovascular field, and printable materials
distributed therewith; educational services, namely,
arranging and conducting classes, seminars and workshops in
the cardiovascular field, and distribution of educational
course materials in connection therewith. Providing a website featuring health information in the
cardiovascular field (Term considered too vague by the
International Bureau pursuant to Rule 13 (2) (b) of the
Regulations).
69.
Process for Synthesizing Naphthyridine Derivatives and Intermediates Thereof
The disclosure provides processes for preparing Compound A, Compound E, Compound I, salts thereof, and/or stereoisomers thereof, as described herein.
The disclosure provides processes for preparing Compound A, Compound E, Compound I, salts thereof, and/or stereoisomers thereof, as described herein.
C07D 491/147 - Ortho-condensed systems the condensed system containing one ring with oxygen as ring hetero atom and two rings with nitrogen as ring hetero atom
70.
PALLADIUM FREE PROCESSES FOR PREPARATION OF ACRYLATE COMPOUNDS
The present invention relates to precious metal (Pd/Pt/Rh/Ru) free, preferably Pd free, processes for preparing a compound having formula (1) wherein: R1, R2, and X are as defined in the specification, or a salt thereof. Preferably, the compound is an iodo acrylate compound.
The present invention relates to precious metal (Pd/Pt/Rh/Ru) free, preferably Pd free, processes for preparing a compound having formula (1) wherein: R1, R2, and X are as defined in the specification, or a salt thereof. Preferably, the compound is an iodo acrylate compound.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the treatment of diabetes, endocrine diseases and disorders, metabolic diseases and disorders, and obesity; Pharmaceutical preparations for weight reduction and long-term weight loss maintenance.
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Research and development of pharmaceutical preparations; research and development of pharmaceutical preparations in the field of metabolic diseases, namely weight management and diabetes; medical and scientific research information in clinical trials in the field of metabolic diseases, namely weight management and diabetes; providing websites featuring medical and scientific research information about the diagnostic, prophylactic and therapeutic properties of pharmaceuticals in the field of metabolic diseases, namely weight management and diabetes; providing websites featuring medical and scientific research information about pharmaceuticals preparations in the field of metabolic diseases, namely weight management and diabetes; providing websites that features non-downloadable computer software that enables users to access, manage, update and display electronic databases in the field of metabolic diseases, namely weight management and diabetes
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations for the treatment of diabetes, endocrine diseases and disorders, metabolic diseases and disorders, and obesity; Pharmaceutical preparations for weight reduction and long-term weight loss maintenance
Methods of determining relative unpaired glycan content of an IgG antibody composition are provided. In exemplary embodiments, the method comprises treating the IgG antibody composition with two enzymes to form a mixture of Fab fragments and Fc fragments, wherein one enzyme cleaves an antibody heavy chain at a site N-terminal to the hinge region disulfide linkages and the other enzyme cleaves the β1,4 linkage between core GlcNAc residues to form Fc fragments each comprising a pair of core glycan structures, (b) separating the Fab fragments from the Fc fragments, and (c) quantifying the abundance of (i) paired afucosylated Fc fragments, (ii) unpaired afucosylated Fc fragments, (iii) paired high mannose Fc fragments, and/or (iv) unpaired high mannose Fc fragments, to determine the relative unpaired afucosylated (AF) glycan content and relative unpaired high mannose (HM) glycan content.
Methods of screening a glass container for storing a pharmaceutical formulation for susceptibility to lamellar silica formation includes filling the container with a buffer for the pharmaceutical formulation, storing the container with the buffer and optically analyzing the buffer after storage for one or more particles in the buffer. The one or more particles can be analyzed to determine a morphology and chemical composition and the interior surface of the container, once emptied, can be analyzed for delamination type deformation. The presence of particles in the buffer having a chemical comprising silicon, oxygen, and carbon and the absence of delamination type deformation is indicative of susceptibility to lamellar silica formation.
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes DetailsAccessories therefor
B08B 17/02 - Preventing deposition of fouling or of dust
C03C 23/00 - Other surface treatment of glass not in the form of fibres or filaments
G01N 21/90 - Investigating the presence of flaws, defects or contamination in a container or its contents
G01N 23/2251 - Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups , or by measuring secondary emission from the material using electron or ion microprobes using incident electron beams, e.g. scanning electron microscopy [SEM]
The present disclosure provides materials and methods for preparing an antibody pharmaceutical formulation having a viscosity of 10 cP or less comprising exchanging a composition comprising the antigen binding protein with a diafiltration buffer comprising calcium at a temperature greater than 30° C.
Provided herein are liquid compositions comprising a high concentration of a monoclonal antibody, e.g., greater than about 100 mg/mL, which demonstrate storage-stability and reduced viscosity. In exemplary embodiments, the liquid composition comprises about less than about 400 mM arginine glutamate, and, in alternative exemplary embodiments, the liquid composition comprises proline and a buffer.
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61K 47/12 - Carboxylic acidsSalts or anhydrides thereof
A61K 47/18 - AminesAmidesUreasQuaternary ammonium compoundsAmino acidsOligopeptides having up to five amino acids
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
83.
LOW-VISCOSITY ANTIGEN BINDING PROTEINS AND METHODS OF MAKING THEM
The present invention concerns a method for preparing antigen binding proteins specific for PCSK9 with reduced viscosity. The method proceeds by replacing residues in high viscosity variable domain subfamilies with residues in correlating low viscosity subfamilies. The method further comprises substituting residues in the Fc domain with residues associated with low viscosity and adding charged residues to the C-terminus of the Fc domain. The present invention further concerns antigen binding proteins produced by this method.
C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
G01N 11/14 - Investigating flow properties of materials, e.g. viscosity or plasticityAnalysing materials by determining flow properties by moving a body within the material by using rotary bodies, e.g. vane
84.
APPARATUSES, SYSTEMS AND METHODS FOR VIAL SEAL INSPECTION
An apparatus, system, or method for vial seal inspection may be based on three-dimensional data that is representative of at least a portion of a vial seal. More particularly, apparatuses, systems, and methods for vial seal inspection may include at least one laser triangulation sensor.
G01M 3/38 - Investigating fluid tightness of structures by using light
G01B 11/25 - Measuring arrangements characterised by the use of optical techniques for measuring contours or curvatures by projecting a pattern, e.g. moiré fringes, on the object
G01N 21/90 - Investigating the presence of flaws, defects or contamination in a container or its contents
85.
COMPOSITION AND METHODS FOR RECOMBINANT LENTIVIRAL PRODUCTION
Disclosed herein are lentiviral plasmid packaging compositions comprising unique mass ratios of four plasmids that are useful in producing lentiviral vectors. Also provided are methods of producing such lentiviral vectors by mixing a complexation solution comprising the lentiviral plasmid packaging composition with a transfection reagent and incubating the mixture for at least 10 minutes. transfecting a eukaryotic host cell with the lentiviral plasmid packaging composition, adding sodium butyrate to the transfected host cells about one day after transfection, and culturing the host cell. Exemplary embodiments of the method comprise a concentration of total plasmid in pg/mL of 0.25-3 and/or a mass ratio of total plasmid mass in pg to the mass of transfection reagent in pg extending from about 1:1 to about 1:3.
KRAS G12CKRAS G12C mutation in a subject in need thereof comprising administering to the subject sotorasib, carboplatin and pemetrexed in amounts effective to treat the cancer.
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
A61K 31/555 - Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 31/714 - Cobalamins, e.g. cyanocobalamin, vitamin B12
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 9/00 - Medicinal preparations characterised by special physical form
The invention disclosed herein relates to methods for reducing aggregation of bispecific antibodies, for example reducing aggregation of bispecific T cell engager (BiTE) antibody constructs, resulting from storage under frozen conditions by holding the antibodies at certain temperatures after thaw.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
88.
INTERLEUKIN-2 MUTEINS FOR THE EXPANSION OF T-REGULATORY CELLS
Provided herein are IL-2 muteins and IL-2 mutein Fc-fusion molecules that preferentially expand and activate T regulatory cells and are amenable to large scale production. Also provided herein are variant human IgG1 Fc molecules lacking or with highly reduced effector function and high stability despite lacking glycosylation at N297. Also, provided herein are linker peptides that are glycosylated when expressed in mammalian cells.
GDF15 molecules are provided herein. In some embodiments, the GDF15 molecule is a GDF15-Fc fusion, in which a GDF15 region is fused to an Fc region. In some embodiments, the GDF15 region is fused to the Fc region via a linker. Also, provided herein arr methods for making and using GDF15 molecules.
This disclosure related to antagonistic dual receptor antigen-binding proteins, e.g. antibodies and methods of using the dual receptor antibodies for treatment of pathological diseases. The dual receptor antibodies may comprise an antibody to ActRII receptors and may be used to treat pathological condition. The pathological conditions can comprise muscle wasting diseases or any disease that requires stimulation of muscle growth.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
A61P 21/00 - Drugs for disorders of the muscular or neuromuscular system
C07K 16/42 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against immunoglobulins (anti-idiotypic antibodies)
The invention pertains to methods of purifying fusion proteins, in particular TNFR:Fc fusion proteins. Methods disclosed herein can be used to produce highly pure TNFR:Fc fusion proteins (e.g., etanercept) having a biological activity by removing hard to separate product related impurities such as clipped and/or mis-fold/aggregated TNFR:Fc fusion proteins.
The invention provides modified apelin polypeptides having increased stability, circulating half-life, and/or potency relative to the native apelin-13 polypeptide. Compositions comprising the modified apelin polypeptides and methods of using the polypeptides for treating cardiac disorders, such as heart failure, are also disclosed.
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/60 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
93.
SALTS AND SOLID STATE FORMS OF A KIF18A INHIBITOR COMPOUND
Disclosed herein is a salt, a crystalline anhydrous form, a hydrate, a solvate, or a co-crystal of a free base compound 2-(6-azaspiro[2.5]octan-6-yl)-N-[2-(4,4-difluoropiperidin-1-yl)-6-methylpyrimidin-4-yl]-4-[(2-hydroxyethanesulfonyl)amino]benzamide (Compound A); method of preparation, pharmaceutical compositions, and method of treating a disease mediated by a motor protein kinesin family member 18A (KIF18A) inhibition, wherein said disease is a neoplastic disease, including a cancer or a tumor.
C07D 401/14 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
A61K 31/506 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
C07C 69/003 - Esters of saturated alcohols having the esterified hydroxy group bound to an acyclic carbon atom
C07C 233/05 - Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having nitrogen atoms of carboxamide groups bound to hydrogen atoms or to carbon atoms of unsubstituted hydrocarbon radicals with carbon atoms of carboxamide groups bound to carbon atoms of an acyclic saturated carbon skeleton having the nitrogen atoms of the carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
C07C 275/06 - Derivatives of urea, i.e. compounds containing any of the groups the nitrogen atoms not being part of nitro or nitroso groups having nitrogen atoms of urea groups bound to acyclic carbon atoms of an acyclic and saturated carbon skeleton
C07C 309/04 - Sulfonic acids having sulfo groups bound to acyclic carbon atoms of an acyclic saturated carbon skeleton containing only one sulfo group
C07C 309/65 - Esters of sulfonic acids having sulfur atoms of esterified sulfo groups bound to acyclic carbon atoms of a saturated carbon skeleton
C07C 309/73 - Esters of sulfonic acids having sulfur atoms of esterified sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton to carbon atoms of non-condensed six-membered aromatic rings
C07D 211/90 - Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
C07D 275/06 - Heterocyclic compounds containing 1, 2-thiazole or hydrogenated 1,2-thiazole rings condensed with carbocyclic rings or ring systems with hetero atoms directly attached to the ring sulfur atom
C07D 307/06 - Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom not condensed with other rings having no double bonds between ring members or between ring members and non-ring members with only hydrogen atoms or radicals containing only hydrogen and carbon atoms, directly attached to ring carbon atoms
C07D 319/12 - 1,4-DioxanesHydrogenated 1,4-dioxanes not condensed with other rings
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations used for the treatment of
cancer; pharmaceutical preparations used for the treatment
of lung, prostate and respiratory disorders.
95.
INTERLEUKIN-2 MUTEINS FOR THE EXPANSION OF T-REGULATORY CELLS
Provided herein are IL-2 muteins, IL-2 mutein Fc-fusion molecules, anti-IL-2 antibodies, and complexes comprising an anti IL-2 antibody bound to an IL-2 cytokine that preferentially expand and activate T regulatory cells and are amenable to large scale production. Also provided herein are variant human IgG1 Fc molecules lacking or with highly reduced effector function and high stability despite lacking glycosylation at N297. Also provided herein are linker peptides that are glycosylated when expressed in mammalian cells. Also provided herein are methods of making and using the compositions of the present invention.
A61P 37/00 - Drugs for immunological or allergic disorders
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
A drug delivery device includes a housing defining a shell having a proximal and a distal end, a needle assembly at least partially disposed within the housing at the proximal end, a drive assembly at least partially disposed within the housing, and a damper mechanism at least partially disposed within the housing adjacent to the distal end. The housing further defines a longitudinal axis extending between the proximal end and the distal end. The needle assembly includes a syringe barrel containing a medicament and a needle or a cannula. The drive assembly is operably coupled to the needle assembly to urge the medicament through the needle or cannula. The damper mechanism is operably coupled to the drive assembly and the housing. Upon activating the drive assembly, the damper mechanism dampens an effect thereof.
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.
A61M 5/20 - Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
A61M 5/315 - PistonsPiston-rodsGuiding, blocking or restricting the movement of the rodAppliances on the rod for facilitating dosing
A61M 5/32 - NeedlesDetails of needles pertaining to their connection with syringe or hubAccessories for bringing the needle into, or holding the needle on, the bodyDevices for protection of needles
F16F 9/16 - Devices with one or more members, e.g. pistons, vanes, moving to and fro in chambers and using throttling effect involving only straight-line movement of the effective parts
F16F 9/32 - Springs, vibration-dampers, shock-absorbers, or similarly-constructed movement-dampers using a fluid or the equivalent as damping medium Details
F16F 9/348 - Throttling passages in the form of annular discs operating in opposite directions
F16F 9/36 - Special sealings, including sealings or guides for piston-rods
98.
METHOD OF USING AN ULTRASONIC FLOW SENSOR TO MONITOR FILL WEIGHT ACCURACY OF CLINICAL, COMMERCIAL, AND PROCESS DEVELOPMENT FILL/FINISH OPERATIONS
The methods and systems of this disclosure generally relate to a process for filling a container with liquid and checking fill amount compliance. Checking the fill amount compliance includes measuring flow rate during a fill time interval using a flow rate sensor (e.g., an ultrasonic sensor). In some example implementations, multiple flow sensors may be used. Furthermore, the disclosure describes a variety of calibration techniques to ensure accurate fill amount measurement using numerical integration of flowrates. Still furthermore, the disclosure describes generating and displaying alerts indicative of noncompliance and/or a variety of failure modes.
G01F 1/66 - Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by measuring frequency, phase shift or propagation time of electromagnetic or other waves, e.g. using ultrasonic flowmeters
G01F 11/12 - Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers moved during operation of the valve type, i.e. the separating being effected by fluid-tight or powder-tight movements
B65B 3/00 - Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans or jars
B65B 3/30 - Methods or devices for controlling the quantity of the material fed or filled by volumetric measurement
G01F 15/075 - Integration to give total flow, e.g. using mechanically-operated integrating mechanism using electrically-operated integrating means
G01F 25/00 - Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume
G01F 25/10 - Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume of flowmeters
G01F 1/58 - Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by electromagnetic flowmeters
G01F 1/7086 - Measuring the time taken to traverse a fixed distance using optical detecting arrangements
G01F 3/20 - Measuring the volume flow of fluids or fluent solid material wherein the fluid passes through the meter in successive and more or less isolated quantities, the meter being driven by the flow with measuring chambers which expand or contract during measurement having flexible movable walls, e.g. diaphragms, bellows
G01F 23/20 - Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm by measurement of weight, e.g. to determine the level of stored liquefied gas
Compounds of formula (I):
Compounds of formula (I):
Compounds of formula (I):
as defined herein, and synthetic intermediates thereof, which are capable of modulating KIF18A protein thereby influencing the process of cell cycle and cell proliferation to treat cancer and cancer-related diseases. The invention also includes pharmaceutical compositions, including the compounds, and methods of treating disease states related to the activity of KIF18A.
C07D 401/14 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
C07D 401/12 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
C07D 405/14 - Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing three or more hetero rings
C07D 413/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms containing three or more hetero rings
C07D 419/14 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen, oxygen, and sulfur atoms as the only ring hetero atoms containing three or more hetero rings
C07D 491/107 - Spiro-condensed systems with only one oxygen atom as ring hetero atom in the oxygen-containing ring
100.
DOSING REGIMEN FOR COMBINATION THERAPY TARGETING DLL3 AND PD-1
The present invention provides a method for the treatment of DLL3-positive cancer or SCLC, comprising administering to a subject in need thereof an anti-DLL3 agent and an anti-PD-1 antibody. Step dosing of the anti-DLL3 agent is also disclosed.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61K 39/00 - Medicinal preparations containing antigens or antibodies
