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11 Dec 2024
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07 Dec 2024
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27 Nov 2024
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25 Nov 2024
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19685
Submission : 2006-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11973
Submission : 1996-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15933
Submission : 2002-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22680
Submission : 2009-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-20
Pay. Date : 2024-02-08
DMF Number : 39514
Submission : 2024-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11971
Submission : 1996-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14078
Submission : 1999-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11499
Submission : 1995-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8583
Submission : 1990-05-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-28
Pay. Date : 2021-12-13
DMF Number : 36570
Submission : 2022-02-08
Status : Active
Type : II
Details:
TEV-'749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine being developed in in adult patients diagnosed with schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Brand Name: TV-44749
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2024
Lead Product(s) : Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Presents Positive Results for Schizophrenia Treatments TEV-'749 and UZEDY®
Details : TEV-'749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine being developed in in adult patients diagnosed with schizophrenia.
Brand Name : TV-44749
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 01, 2024
Details:
Selarsdi (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Brand Name: Selarsdi
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Recipient : Alvotech
Deal Size : Not Applicable
Deal Type : Not Applicable
Alvotech And Teva Gain FDA Approval for SELARSDI Label Expansion
Details : Selarsdi (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.
Brand Name : Selarsdi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 22, 2024
Details:
TVB-009P(denosumab) is a biosimilar candidate to Prolia, which is being developed for the high risk for fracture, such as osteoporosis in postmenopausal women.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: TVB-009P
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Prolia® Biosimilar Candidate Accepted For Review by FDA & EMA
Details : TVB-009P(denosumab) is a biosimilar candidate to Prolia, which is being developed for the high risk for fracture, such as osteoporosis in postmenopausal women.
Brand Name : TVB-009P
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 08, 2024
Details:
mAbxience will lead the development and production of an anti PD-1 biosimilar and Teva will manage regulatory approvals and oversee commercialization of this oncology treatment.
Lead Product(s): Anti PD-1-based Therapy
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Large molecule
Sponsor: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 03, 2024
Lead Product(s) : Anti PD-1-based Therapy
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Mabxience
Deal Size : Undisclosed
Deal Type : Partnership
Teva Expands Partnership with mAbxience for Additional Oncology Biosimilar
Details : mAbxience will lead the development and production of an anti PD-1 biosimilar and Teva will manage regulatory approvals and oversee commercialization of this oncology treatment.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
October 03, 2024
Details:
Sandostatin-Generic (octreotide acetate) is a somatostatin analogue peptide, which is being evaluated for the treatment of acromegaly, carcinoid tumors & vasoactive intestinal peptide tumors.
Lead Product(s): Octreotide Acetate
Therapeutic Area: Endocrinology Brand Name: Sandostatin-Generic
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2024
Lead Product(s) : Octreotide Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Launches First Generic Version of Sandostatin® LAR Depot in The U.S.
Details : Sandostatin-Generic (octreotide acetate) is a somatostatin analogue peptide, which is being evaluated for the treatment of acromegaly, carcinoid tumors & vasoactive intestinal peptide tumors.
Brand Name : Sandostatin-Generic
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 01, 2024
Details:
FDA has approved Teva's AUSTEDO XR (deutetrabenazine,vmat2 inhibitor) extended-release tablets as a once-daily treatment option for adults with tardive dyskinesia and Huntington’s disease chorea.
Lead Product(s): Deutetrabenazine
Therapeutic Area: Neurology Brand Name: Austedo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2024
Lead Product(s) : Deutetrabenazine
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Shows Long-Term Safety of Deutetrabenazine For Tardive Dyskinesia
Details : FDA has approved Teva's AUSTEDO XR (deutetrabenazine,vmat2 inhibitor) extended-release tablets as a once-daily treatment option for adults with tardive dyskinesia and Huntington’s disease chorea.
Brand Name : Austedo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 23, 2024
Details:
TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Brand Name: TEV-‘749
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2024
Lead Product(s) : Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Presents Phase 3 Data on TEV-‘749 as Long-Acting Injectable for Schizophrenia
Details : TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.
Brand Name : TEV-‘749
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 21, 2024
Details:
TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Brand Name: TEV-‘749
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: MedinCell
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2024
Lead Product(s) : Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : MedinCell
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Updates on Pivotal Phase 3 Trial of Olanzapine Long-Acting Injectable
Details : TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.
Brand Name : TEV-‘749
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 05, 2024
Details:
TEV-’574 (duvakitug) is a potential best-in-class human IgG1-lambda 2 mAb that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15).
Lead Product(s): Duvakitug
Therapeutic Area: Gastroenterology Brand Name: TEV-48574
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Sanofi
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2024
Lead Product(s) : Duvakitug
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Sanofi
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva and Sanofi Announce Accelerated Timeline for Anti-TL1A in Bowel Disease
Details : TEV-’574 (duvakitug) is a potential best-in-class human IgG1-lambda 2 mAb that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15).
Brand Name : TEV-48574
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 24, 2024
Details:
Ajovy (fremanezumab) a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in 6-17 years patients.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Brand Name: Ajovy
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2024
Lead Product(s) : Fremanezumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Touts First CGRP Success in Phase III Paediatric Migraine Prevention Study
Details : Ajovy (fremanezumab) a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in 6-17 years patients.
Brand Name : Ajovy
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 19, 2024
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