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05 Sep 2023
// GLOBENEWSWIRE
https://www.globenewswire.com//news-release/2023/09/05/2737950/0/en/Medexus-Pharmaceuticals-Announces-C-10-Million-Bought-Deal-Public-Offering-of-Units.html
18 Apr 2023
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https://www.globenewswire.com/news-release/2023/04/11/2644251/0/en/Medexus-Expects-Record-Revenue-for-Fiscal-Year-2023-and-Provides-Business-Update.html
22 Mar 2023
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06 Mar 2023
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08 Feb 2023
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https://www.globenewswire.com/news-release/2023/02/08/2604508/0/en/Medexus-Announces-Another-Record-Quarter-with-Fiscal-Q3-2023-Revenue-of-US-28-7-Million-a-35-Increase-Over-Fiscal-Q3-2022.html
Details:
Trecondyv (treosulfan) is used to prepare patients for blood stem cell transplant. Trecondyv destroys bone marrow cells. This allows for the transplant of new blood stem cells from a donor which leads to the production of healthy blood cells.
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Trecondyv
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medexus Provides Update on Treosulfan NDA Resubmission and Provides Business Update
Details : Trecondyv (treosulfan) is used to prepare patients for blood stem cell transplant. Trecondyv destroys bone marrow cells. This allows for the transplant of new blood stem cells from a donor which leads to the production of healthy blood cells.
Brand Name : Trecondyv
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 19, 2022
Details:
Study found event-free survival and overall survival superior after Trecondyv (treosulfan) compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm.
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Trecondyv
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Medac
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Medac
Deal Size : Not Applicable
Deal Type : Not Applicable
Treosulfan Pivotal Study Results Published
Details : Study found event-free survival and overall survival superior after Trecondyv (treosulfan) compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm.
Brand Name : Trecondyv
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 06, 2022
Details:
Trecondyv (treosulfan), preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, is medication given to people before they have bone marrow transplant from a donor allogeneic hematopoietic stem cell transplantation
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Trecondyv
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2022
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medexus Pharmaceuticals Provides Update on Resubmission of Treosulfan NDA
Details : Trecondyv (treosulfan), preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, is medication given to people before they have bone marrow transplant from a donor allogeneic hematopoietic ste...
Brand Name : Trecondyv
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 25, 2022
Details:
The resubmission includes additional clinical data and statistical analysis relating to previously-completed phase 3 clinical trial of Treosulfan as well as an update of integrated summary of safety, which FDA had requested in their July 2021 Complete Response Letter to medac.
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Treosulfan
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA
Details : The resubmission includes additional clinical data and statistical analysis relating to previously-completed phase 3 clinical trial of Treosulfan as well as an update of integrated summary of safety, which FDA had requested in their July 2021 Complete Re...
Brand Name : Treosulfan
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 22, 2022
Details:
Treosulfan will be marketed in Canada under the brand name Trecondyv® and indicated in combination with fludarabine as part of a conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (“allo-HSCT”).
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Trecondyv
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Medac
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 12, 2021
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Medac
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Treosulfan will be marketed in Canada under the brand name Trecondyv® and indicated in combination with fludarabine as part of a conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (“allo-HSCT”).
Brand Name : Trecondyv
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 12, 2021
Details:
Medac intends to leverage its strong, existing commercial infrastructure in the United States to address the underserved allo-HSCT market through its commercialization of treosulfan.
Lead Product(s): Treosulfan,Fludarabine Phosphate
Therapeutic Area: Oncology Brand Name: Trecondi
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Medac
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 02, 2021
Lead Product(s) : Treosulfan,Fludarabine Phosphate
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Medac
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Medexus and Medac Enter Into a License Agreement for Treosulfan, in the United States
Details : Medac intends to leverage its strong, existing commercial infrastructure in the United States to address the underserved allo-HSCT market through its commercialization of treosulfan.
Brand Name : Trecondi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 02, 2021
Details:
Triamcinolone Hexacetonide is a longest-acting corticosteroid for intra articular injection. The companies have agreed to a small upfront fee along with milestone payments at the time of FDA approval, at commercial product launch, and upon certain sales milestones.
Lead Product(s): Triamcinolone Acetonide
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Ethypharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 18, 2020
Lead Product(s) : Triamcinolone Acetonide
Therapeutic Area : Immunology
Highest Development Status : Approved
Recipient : Ethypharm
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Triamcinolone Hexacetonide is a longest-acting corticosteroid for intra articular injection. The companies have agreed to a small upfront fee along with milestone payments at the time of FDA approval, at commercial product launch, and upon certain sales ...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 18, 2020
Details:
Medexus reached the 50% enrollment target in its Phase 4 clinical trial investigating IXINITY® as a prophylactic treatment for pediatric patients under 12 years of age with hemophilia B.
Lead Product(s): Recombinant coagulation factor IX
Therapeutic Area: Genetic Disease Brand Name: Ixinity
Study Phase: Phase IVProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Lead Product(s) : Recombinant coagulation factor IX
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medexus Reaches 50% Enrollment in IXINITY® Phase 4 Clinical Trial Targeting Label Expansion for P...
Details : Medexus reached the 50% enrollment target in its Phase 4 clinical trial investigating IXINITY® as a prophylactic treatment for pediatric patients under 12 years of age with hemophilia B.
Brand Name : Ixinity
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 16, 2020
Details:
Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (TH) has been approved for inclusion as a general benefit (open listing) on the List of Medications- Institutions administered by the Régie de l’assurance maladie du Québec (RAMQ), effective August 19, 2020.
Lead Product(s): Triamcinolone Acetonide
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Lead Product(s) : Triamcinolone Acetonide
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medexus Reports Triamcinolone Hexacetonide Injectable Suspension Approved for Inclusion on Quebec...
Details : Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (TH) has been approved for inclusion as a general benefit (open listing) on the List of Medications- Institutions administered by the Régie de l’assurance maladie du Québec (RAMQ), effective A...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 24, 2020
Details:
TH is the longest acting corticosteroid for intra-articular injection, often lasting twice as long as comparator products.
Lead Product(s): Triamcinolone Acetonide
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Lead Product(s) : Triamcinolone Acetonide
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : TH is the longest acting corticosteroid for intra-articular injection, often lasting twice as long as comparator products.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 09, 2020
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 7.5MG/0.15ML (7.5MG/0.15...
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 10MG/0.20ML (10MG/0.20ML...
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 12.5MG/0.25ML (12.5MG/0....
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 15MG/0.30ML (15MG/0.30ML...
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 17.5MG/0.35ML (17.5MG/0....
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 20MG/0.4ML (20MG/0.4ML)
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 22.5MG/0.45ML (22.5MG/0....
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 25MG/0.5ML (25MG/0.5ML)
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 27.5MG/0.55ML (27.5MG/0....
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; SUBCUTANEOUS
Proprietary Name : RASUVO
Dosage Strength : 30MG/0.6ML (30MG/0.6ML)
Approval Date : 2014-07-10
Application Number : 205776
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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