Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.
Type:
Grant
Filed:
June 6, 2023
Date of Patent:
February 11, 2025
Assignees:
F. HOFFMANN-LA ROCHE AG, GENENTECH, INC.
Inventors:
Markus Hemminger, Ulla Grauschopf, Frank Bamberg, Mayumi Bowen, Robert Müller, Flora Felsovalyi, Denny Christensen
Abstract: The invention provides a means for a treatment for a demyelinating disease of the central nervous system (CNS) characterized by the presence of an anti-myelin oligodendrocyte glycoprotein (MOG) antibody, and also for reducing the risk of relapse in the demyelinating disease, comprising an anti-IL-6 receptor antibody or antigen binding fragment thereof.
Type:
Application
Filed:
November 25, 2022
Publication date:
January 30, 2025
Applicants:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Inventors:
Takatoshi Ozawa, Mai Yamashiro, Hajime Ito, Shunsuke Yoshida, Jillian Smith, Ivana Vodopivec, Sian Lennon-Chrimes, Gaelle Klingelschmitt, Hans-Christian Von Buedingen, Hanna Silber Baumann
Abstract: An object of the present disclosure is to provide a staked-in needle prefilled syringe formulation containing an antibody engineered by a mutation to histidine, which reduces the difficulty in pushing out a drug and the risk of causing clogging in a needle. The staked-in needle prefilled syringe formulation can be produced by a simple method on an industrial scale. The present prefilled syringe formulation is characterized by having an elastomeric needle shield having a low zinc leaching capacity.
Type:
Application
Filed:
July 27, 2021
Publication date:
November 21, 2024
Applicants:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Inventors:
Masakazu Fukuda, Shogo Yamashita, Yuji Yamanaka, Robert Mueller, Kewei Yang
Abstract: Composition comprising recombinant Gplb? receptor protein Various aspects of the invention relate to recombinant polypeptides that specifically bind human von Willebrand Factor. Such recombinant polypeptides typically include a modified extracellular domain of platelet glycoprotein Ib? that typically comprises at least one mutation selected from G233T, D235V, and K237V, and such recombinant polypeptides optionally include an oligomerization domain.
Type:
Application
Filed:
July 17, 2023
Publication date:
August 22, 2024
Applicant:
F. HOFFMANN-LA ROCHE AG
Inventors:
Elizabeth Booth, Virginia Montanini, John A. Hall, Jody Berry
Abstract: An objective of the present invention is to provide an effective pharmaceutical composition or a dosage regimen for preventing and/or treating bleeding, a disease accompanying bleeding, or a disease caused by bleeding. The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes (a) blood coagulation factor IX and/or activated blood coagulation factor IX and (b) blood coagulation factor X and/or activated blood coagulation factor X according to a given dosage regimen, bleeding, a disease accompanying bleeding, or a disease caused by bleeding can be prevented and/or treated more effectively.
Type:
Application
Filed:
September 14, 2023
Publication date:
February 15, 2024
Applicants:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Abstract: A method is provided for determining the efficacy of GPC3-targeting drug therapy for cancer in a patient before the start of GPC3-targeting drug therapy or for determining the continuation of GPC3-targeting drug therapy for a patient treated with GPC3-targeting therapy. The method includes determining the number of an immunocyte or an expression level of a molecule expressed on the immunocyte in a biological sample isolated from the patient before the start of GPC3-targeting drug therapy and/or the patient treated with the GPC3-targeting drug therapy, wherein when the number of the immunocyte or the expression level of the molecule expressed on the immunocyte is a predetermined value, the efficacy of the GPC3-targeting drug therapy is determined or the continuation of the GPC3-targeting drug therapy is determined. GPC3-targeting drugs and drug preparations for use according to the disclosed methods are also provided.
Type:
Grant
Filed:
May 8, 2015
Date of Patent:
September 19, 2023
Assignees:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Inventors:
Toshihiko Ohtomo, Takayoshi Tanaka, Yasuo Sugitani, Oscar Puig, Ruey-min Lee, Gong Chen, Anton Belousov, Ya-Chi Chen, Bernhard Reis
Abstract: Provided herein are compounds of Formula (I): and forms thereof, wherein w1, w2, w3, w4, w5, w6 and w7 are as defined herein, including compositions thereof and uses therewith for treating spinal muscular atrophy.
Type:
Grant
Filed:
October 5, 2020
Date of Patent:
September 12, 2023
Assignees:
PTC Therapeutics, Inc., F. Hoffmann-La Roche AG
Inventors:
Hongyan Qi, Soongyu Choi, Amal Dakka, Gary Mitchell Karp, Jana Narasimhan, Nikolai Naryshkin, Anthony A. Yurpoff, Marla L. Weetall, Ellen Welch, Matthew G. Woll, Tianle Yang, Nanjing Zhang, Xiaoyan Zhang, Xin Zhao, Luke Green, Emmanuel Pinard, Hasane Ratni
Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.
Type:
Grant
Filed:
September 28, 2018
Date of Patent:
August 29, 2023
Assignees:
F. HOFFMANN-LA ROCHE AG, GENENTECH, INC.
Inventors:
Markus Hemminger, Ulla Grauschopf, Frank Bamberg, Mayumi Bowen, Robert Müller, Flora Felsovalyi, Denny Christensen
Abstract: An objective of the present invention is to provide an effective pharmaceutical composition or a dosage regimen for preventing and/or treating bleeding, a disease accompanying bleeding, or a disease caused by bleeding. The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes (a) blood coagulation factor IX and/or activated blood coagulation factor IX and (b) blood coagulation factor X and/or activated blood coagulation factor X according to a given dosage regimen, bleeding, a disease accompanying bleeding, or a disease caused by bleeding can be prevented and/or treated more effectively.
Type:
Application
Filed:
January 19, 2023
Publication date:
May 25, 2023
Applicants:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Abstract: This application relates to anti-D-Dimer recombinant antibodies that specifically bind to fibrin and fibrinogen degradation products (FDP) such as D-Dimer, fragment DD and fragment D with high binding affinity and do not bind to fragment E and fibrinogen. The present invention also refers to methods and assays for detection of D-Dimer and FDP fragments in samples using said recombinant antibodies.
Type:
Application
Filed:
February 19, 2021
Publication date:
March 16, 2023
Applicant:
F. Hoffmann-La Roche AG
Inventors:
Elizabeth A. Booth, Charles Holz, Tristan Wasley, Virginia Montanini, Jody Berry
Abstract: The invention provides formulations comprising a protein in combination with a compound that prevents oxidation of the protein. The invention also provides methods for making such formulations and methods of using such formulations. The invention further provides methods of screening for compounds that prevent oxidation of a protein in a protein composition and methods of preventing oxidation of a protein in a formulation.
Type:
Grant
Filed:
November 22, 2017
Date of Patent:
March 7, 2023
Assignee:
F. HOFFMANN-LA ROCHE AG
Inventors:
Sreedhara Alavattam, Mary Mallaney, Parbir Grewal
Abstract: An objective of the present invention is to provide an effective pharmaceutical composition or a dosage regimen for preventing and/or treating bleeding, a disease accompanying bleeding, or a disease caused by bleeding. The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes (a) blood coagulation factor IX and/or activated blood coagulation factor IX and (b) blood coagulation factor X and/or activated blood coagulation factor X according to a given dosage regimen, bleeding, a disease accompanying bleeding, or a disease caused by bleeding can be prevented and/or treated more effectively.
Type:
Application
Filed:
May 31, 2022
Publication date:
October 6, 2022
Applicants:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Abstract: An objective of the present invention is to provide an effective pharmaceutical composition or a dosage regimen for preventing and/or treating bleeding, a disease accompanying bleeding, or a disease caused by bleeding. The inventors discovered that by administering a pharmaceutical composition comprising a bispecific antigen-binding molecule that recognizes (a) blood coagulation factor IX and/or activated blood coagulation factor IX and (b) blood coagulation factor X and/or activated blood coagulation factor X according to a given dosage regimen, bleeding, a disease accompanying bleeding, or a disease caused by bleeding can be prevented and/or treated more effectively.
Type:
Grant
Filed:
September 5, 2017
Date of Patent:
June 7, 2022
Assignees:
Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche AG
Abstract: The present invention relates to oligomer compounds (oligomers), which target Tau mRNA in a cell, leading to reduced expression of Tau protein. Reduction of Tau protein expression is beneficial for the treatment of certain medical disorders, e.g., a neurological disorder.
Type:
Application
Filed:
July 2, 2021
Publication date:
May 12, 2022
Applicant:
F. Hoffmann-La Roche AG
Inventors:
Richard E. Olson, Angela M. Cacace, Peter Hagedorn, Anja Mølhart Høg, Marianne Lerbech Jensen, Niels Fisker Nielsen, Dong Li, Jeffrey M. Brown, Stephen E. Mercer
Abstract: The present invention relates to variable domains of a camelid heavy-chain antibodies directed against a phosphorylated tau protein and conjugates thereof. The present invention also relates to the use of these domains or conjugates for treating or diagnosing disorders mediated by neurofibrillary tangles, neuropil threads or dystrophic neurites, such as tauopathies.
Type:
Grant
Filed:
December 2, 2019
Date of Patent:
September 21, 2021
Assignees:
F. HOFFMANN-LA ROCHE AG, INSTITUT PASTEUR, COMMISSARIAT A L'ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES, CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE (CNRS)
Inventors:
Pierre Lafaye, Sylvie Bay, Benoit Delatour, Marc Dhenain, Charles Duyckaerts, Tengfei Li, Matthias Vandesquille, Christian Czech, Fiona Grueninger
Abstract: The present invention relates to oligomer compounds (oligomers), which target Tau mRNA in a cell, leading to reduced expression of Tau protein. Reduction of Tau protein expression is beneficial for the treatment of certain medical disorders, e.g., a neurological disorder.
Type:
Grant
Filed:
February 4, 2016
Date of Patent:
August 3, 2021
Assignee:
F. HOFFMANN-LA ROCHE AG
Inventors:
Richard E. Olson, Angela M. Cacace, Peter Hagedorn, Anja Mølhart Høg, Marianne Lerbech Jensen, Niels Fisker Nielsen, Dong Li, Jeffrey M. Brown, Stephen E. Mercer
Abstract: The problem to be solved is to provide an antibody-containing formulation which is stable and suited for subcutaneous administration, wherein dimerization and deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and methionine.
Type:
Grant
Filed:
April 22, 2019
Date of Patent:
May 18, 2021
Assignees:
CHUGAI SEIYAKU KABUSHIKI KAISHA, F. HOFFMANN-LA ROCHE AG
Inventors:
Toshiyuki Morichika, Daisuke Kameoka, Yoshimi Imaeda, Terutoshi Maeda, Oliver Boris Stauch
Abstract: The present invention relates to oligomer compounds (oligomers), which target Tau mRNA in a cell, leading to reduced expression of Tau protein. Reduction of Tau protein expression is beneficial for the treatment of certain medical disorders, e.g., a neurological disorder.
Type:
Grant
Filed:
February 4, 2016
Date of Patent:
October 13, 2020
Assignee:
F. HOFFMANN-LA ROCHE AG
Inventors:
Richard E. Olson, Angela M. Cacace, Peter Hagedorn, Anja Mølhart Høg, Dong Li, Jeffrey M. Brown, Marianne Lerbech Jensen, Niels Fisker Nielsen, Stephen E. Mercer