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CPhI North America CPhI North America
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29 April-01 May, 2025
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INTERVIEW #SpeakPharma
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17 Apr 2025
// ACCESSWIRE
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/us-district-court-grants-summary-judgment-in-favor-of-fda-salix-and-t-1016430
08 Apr 2025
// BIOSPACE
https://www.biospace.com/actavis-to-slash-200-workers-as-part-of-teva-s-consolidation-efforts
07 Apr 2025
// PRESS RELEASE
https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Samsung-Bioepis-Announce-Biosimilar-EPYSQLI-eculizumab-aagh-InjectionNow-Available-in-the-United-States/default.aspx
07 Apr 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/04/07/3056596/0/en/Teva-Announces-FDA-Filing-Acceptance-for-AJOVY-fremanezumab-in-Pediatric-Episodic-Migraine-Prevention.html
31 Mar 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/03/31/3052605/0/en/New-Data-Strengthens-Teva-s-Schizophrenia-Portfolio-Including-Phase-3-SOLARIS-Trial-Survey-Results-Demonstrating-Patient-and-Healthcare-Professional-Satisfaction-with-TEV-749-olanz.html
27 Mar 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/03/27/3051046/0/en/Teva-Releases-Q1-2025-Aide-Memoire.html
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 3062
Submission : 1977-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-27
Pay. Date : 2014-10-22
DMF Number : 28764
Submission : 2014-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2833
Submission : 1977-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4040
Submission : 1980-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-04
DMF Number : 16144
Submission : 2002-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 24934
Submission : 2011-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14654
Submission : 1999-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12209
Submission : 1996-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20064
Submission : 2006-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
Teva Pharmaceutical Industries
About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a ye...
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: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2025
Lead Product(s) : Fremanezumab
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva’s AJOVY Accepted By FDA For Pediatric Migraine Prevention
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.
Product Name : Ajovy
Product Type : Antibody
Upfront Cash : Inapplicable
April 07, 2025
Details:
Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Lead Product(s): Eculizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Epysqli
Study Phase: Approved FDFProduct Type: Antibody
Recipient: Samsung Bioepis
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 07, 2025
Lead Product(s) : Eculizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Recipient : Samsung Bioepis
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva and Samsung Bioepis Launch EPYSQLI in the U.S.
Details : Epysqli (eculizumab) is a complement C5 inhibitor antibody which is indicated to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Product Name : Epysqli
Product Type : Antibody
Upfront Cash : Inapplicable
April 07, 2025
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: TEV-‘749
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2025
Lead Product(s) : Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva Highlights Positive Schizophrenia Data From SOLARIS Trial
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.
Product Name : TEV-‘749
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 31, 2025
Details:
Uzedy (risperidone) is an extended-release 5HT2a/D2 receptor Inhibitor injectable suspension, being investigated for the maintenance treatment of BP-I in adults.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Brand Name: Uzedy
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: MedinCell
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2025
Lead Product(s) : Risperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : MedinCell
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva, Medincell Get FDA Acceptance for UZEDY in Bipolar I Disorder
Details : Uzedy (risperidone) is an extended-release 5HT2a/D2 receptor Inhibitor injectable suspension, being investigated for the maintenance treatment of BP-I in adults.
Product Name : Uzedy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 25, 2025
Details:
TEV-'749 (olanzapine) is a novel D2/5-HT2 receptor inhibitor which is under phase 3 clinical development for the treatment of patients with Schizophrenia.
Lead Product(s): Olanzapine
Therapeutic Area: Psychiatry/Psychology Brand Name: TEV-'749
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 10, 2025
Lead Product(s) : Olanzapine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva Completes Pivotal Phase 3 Olanzapine LAI Trial in Schizophrenia
Details : TEV-'749 (olanzapine) is a novel D2/5-HT2 receptor inhibitor which is under phase 3 clinical development for the treatment of patients with Schizophrenia.
Product Name : TEV-'749
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 10, 2025
Details:
Acquiring the US rights to PROVIGIL (modafinil) and NUVIGIL (armodafinil) indicated to improve wakefulness in adult patients marks a strategic milestone for Apotex.
Lead Product(s): Modafinil
Therapeutic Area: Sleep Brand Name: Provigil
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Apotex Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 09, 2025
Lead Product(s) : Modafinil
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Apotex Inc
Deal Size : Undisclosed
Deal Type : Acquisition
Apotex Acquires US rights to PROVIGIL® (modafinil) and NUVIGIL® (armodafinil)
Details : Acquiring the US rights to PROVIGIL (modafinil) and NUVIGIL (armodafinil) indicated to improve wakefulness in adult patients marks a strategic milestone for Apotex.
Product Name : Provigil
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 09, 2025
Details:
Neuraxpharm has acquired these products Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of EDS in adults with narcolepsy.
Lead Product(s): Modafinil
Therapeutic Area: Sleep Brand Name: Provigil
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Neuraxpharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 07, 2025
Lead Product(s) : Modafinil
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Neuraxpharm
Deal Size : Undisclosed
Deal Type : Acquisition
Neuraxpharm Acquires Provigil®, Nuvigil® to Expand Branded Business
Details : Neuraxpharm has acquired these products Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of EDS in adults with narcolepsy.
Product Name : Provigil
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 07, 2025
Details:
Through the acquisition, Eton will add additional commercial and strategic rare disease products such as Galzin (zinc acetate), which is an FDA-approved product for the treatment of Wilson's Disease.
Lead Product(s): Zinc Acetate Dihydrate
Therapeutic Area: Genetic Disease Brand Name: Galzin
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Eton Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 03, 2025
Lead Product(s) : Zinc Acetate Dihydrate
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Eton Pharmaceuticals Advances its Commitment to Rare Disease with Acquisition of Galzin
Details : Through the acquisition, Eton will add additional commercial and strategic rare disease products such as Galzin (zinc acetate), which is an FDA-approved product for the treatment of Wilson's Disease.
Product Name : Galzin
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 03, 2025
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: Immunology Brand Name: TEV-48574
Study Phase: Phase IIProduct Type: Other Large Molecule
Sponsor: Sanofi
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 17, 2024
Lead Product(s) : Duvakitug
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Sanofi
Deal Size : Inapplicable
Deal Type : Inapplicable
Duvakitug Phase 2b Results Show Best-in-Class Potential in Ulcerative Colitis, Crohn’s
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).
Product Name : TEV-48574
Product Type : Other Large Molecule
Upfront Cash : Inapplicable
December 17, 2024
Details:
Ajovy is a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in adult Chinese patients.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Brand Name: Ajovy
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 04, 2024
Lead Product(s) : Fremanezumab
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva Confirms AJOVY® Efficacy for Migraine Prevention from China Study
Details : Ajovy is a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in adult Chinese patients.
Product Name : Ajovy
Product Type : Antibody
Upfront Cash : Inapplicable
November 04, 2024
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