公开(公告)号：US20210238267A1

公开(公告)日：2021-08-05

申请号：US17234658

申请日：2021-04-19

Applicant: Baxalta Incorporated ,  Baxalta GmbH

Inventor： David M. Gelmont ,  Julia Singer ,  Sandor Fritsch ,  Hans-Peter Schwarz

IPC: C07K16/18 ,  A61K38/47 ,  G01N33/68 ,  A61K39/395 ,  C07K16/06 ,  C07K16/00 ,  A61P25/28

Abstract: The present invention provides, among other aspects, methods for the treatment of Alzheimer's disease in a subject in need thereof, the method including administration of a therapeutically effective amount of a pooled human immunoglobulin G (IgG) composition to a subject with moderately severe Alzheimer's disease, a subject carrying an ApoE4 allele, or both, where the amount of pooled human IgG is from 300 mg/kg to 800 mg/kg body weight of the subject per two week period, and where the amount is administered in one or more doses during the two week period after initiation of a therapeutic regimen. Also provided, are methods for selecting a treatment regimen for a subject with Alzheimer's disease, including diagnosing the severity of the Alzheimer's disease, determining if the subject carries an APOE4 allele, or both, and assigning a treatment regimen including administration of pooled human immunoglobulin G and/or an anti-beta amyloid monoclonal antibody.

公开(公告)号：US20210187105A1

公开(公告)日：2021-06-24

申请号：US17139772

申请日：2020-12-31

Applicant: Baxalta Incorporated ,  Baxalta GmbH

Inventor： Randolf Kerschbaumer ,  Dirk Voelkel ,  Friedrich Scheiflinger ,  Hartmut Ehrlich

IPC: A61K39/395 ,  A61K31/56 ,  A61K31/58 ,  A61K31/573 ,  C07K16/24

Abstract: The present invention pertains to anti-MIF antibodies, in particular their use in combination with glucocorticoids, in the treatment of glucocorticoid receptive diseases.

公开(公告)号：US20210128701A1

公开(公告)日：2021-05-06

申请号：US16592554

申请日：2019-10-03

Applicant: Baxalta Incorporated ,  Baxalta GmbH ,  Katholieke Universiteit Leuven

Inventor： Barbara PLAIMAUER ,  Hanspeter Rottensteiner ,  Friedrich Scheiflinger ,  Simon De Meyer ,  Frederik Denorme

IPC: A61K38/48 ,  A61P9/10

Abstract: Provided herein are methods for recanalization of occluded blood vessels in a subject having an infarction. The method includes a step of administering to the subject a therapeutically effective amount of isolated ADAMTS13 protein at particular dosages and ranges of times after detection of the infarction. As described herein, ADAMTS13 advantageously recanalizes occluded blood vessels and reduces infarction size, even when administered a prolonged period after stable occlusion. Accordingly, such methods and compositions are useful for the treatment of infractions caused by blood vessel occlusion.

公开(公告)号：US20210032567A1

公开(公告)日：2021-02-04

申请号：US16760608

申请日：2018-10-30

Applicant: Baxalta Incorporated ,  Baxalta GmbH

Inventor： Jean-Baptiste FARCET ,  Johanna KINDERMANN ,  Björn TILLE ,  Thomas R. KERIL

IPC: C11D1/72 ,  C12N7/00 ,  C07K16/06 ,  C07K14/765 ,  C08G59/14 ,  C11D3/43 ,  C11D3/36

Abstract: The present invention relates to methods for inactivating a lipid-enveloped virus using environmentally compatible detergents, and to methods for preparing a biopharmaceutical drug using environmentally compatible detergents. The invention also provides environmentally compatible detergents.

公开(公告)号：US20210027876A1

公开(公告)日：2021-01-28

申请号：US17070599

申请日：2020-10-14

Applicant: BAXALTA INCORPORATED ,  BAXALTA GMBH

Inventor： Kameswara Rao Kuchimanchi ,  Alexandra Loew-Baselli ,  Gerald Spotts ,  Myungshin Oh ,  Michael Don Hale ,  Martin Wolfsegger

IPC: G16H20/17 ,  G16H50/70 ,  G16H50/20 ,  G16C20/30 ,  G16C20/50 ,  G16C20/70 ,  G06N7/00

Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.

公开(公告)号：US10822394B2

公开(公告)日：2020-11-03

申请号：US16125141

申请日：2018-09-07

Applicant: Baxalta Incorporated ,  Baxalta GmbH

Inventor： Leopold Grillberger ,  Manfred Reiter ,  Wolfgang Mundt

IPC: A61K48/00 ,  C07K14/755 ,  C12N9/64 ,  A61K9/00 ,  A61K38/36 ,  A61K38/37 ,  C12P21/00 ,  A61K38/00

Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimericWF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.

公开(公告)号：US10772968B2

公开(公告)日：2020-09-15

申请号：US15707844

申请日：2017-09-18

Applicant: Lipoxen Technologies Limited ,  Baxalta Incorporated ,  Baxalta GmbH

Inventor： Sanjay Jain ,  Gregory Gregoriadis ,  Archana Dwivedi ,  Srijit Nath ,  Juergen Siekmann ,  Stefan Haider ,  Hanspeter Rottensteiner ,  Peter Turecek

IPC: A61K47/64 ,  C08B37/00 ,  C12N9/96 ,  A61K47/60 ,  A61K47/61 ,  A61K47/62 ,  C07K1/107 ,  A61K47/65 ,  C12N9/64 ,  A61K38/48 ,  A61K38/37 ,  C07K14/755

Abstract: A water soluble polymer, in particular polysialic acid (PSA) or a modified PSA (mPSA), is conjugated to an oxidized carbohydrate moiety of a glycoprotein other than a blood coagulation protein or to a ganglioside or drug delivery system by contacting the oxidized carbohydrate moiety with the water soluble polymer, wherein said water soluble polymer contains an aminooxy group and an oxime linkage is formed between the oxidized carbohydrate moiety and the aminooxy group on the water soluble polymer or wherein said water soluble polymer contains a hydrazide group and a hydrazone linkage is formed between the oxidized carbohydrate moiety and the hydrazide group on the water soluble polymer. Conjugates of aminooxy- or hydrazide-water soluble polymer, such as PSA and mPSA, are thus obtained in which the PSA or mPSA is attached via a carbohydrate moiety.

公开(公告)号：USD893046S1

公开(公告)日：2020-08-11

申请号：US29665393

申请日：2018-10-03

Applicant: Baxalta GmbH ,  Baxalta Incorporated

Designer： Seth Dale Jones ,  Madeleine Clare Gibson ,  Daniel Edward Roush

公开(公告)号：US20200207840A1

公开(公告)日：2020-07-02

申请号：US16817392

申请日：2020-03-12

Applicant: Baxalta GmbH ,  Baxalta Incorporation

Inventor： Dirk Voelkel ,  Patrice Douillard ,  Gerhard Antoine ,  Randolf Kerschbaumer

IPC: C07K16/06 ,  C07K16/24 ,  G01N33/68

Abstract: The invention concerns a detection method to enable the detection of complexes formed between antibodies and antigen which is endogenous to the production cell line, e.g. CHO MIF in a final product.

公开(公告)号：US20200206318A1

公开(公告)日：2020-07-02

申请号：US16802118

申请日：2020-02-26

Applicant: Baxalta Incorporated ,  Baxalta GmbH

Inventor： Miranda Chapman ,  Bruce Ewenstein ,  Bettina Ploder

IPC: A61K38/37 ,  A61K38/36 ,  A61P7/04

Abstract: The present invention relates to a method for treating gastrointestinal bleeding in a subject with severe von Willebrand Disease comprising administering to the subject at least one dose of recombinant von Willebrand Factor (rVWF) ranging from about 40 IU/kg to about 100 IU/kg, wherein the first dose further comprises recombinant Factor VIII (rFVIII).