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21 Nov 2024
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https://www.contractpharma.com//contents/view_breaking-news/2024-11-21/kedrions-facility-in-bolognana-approved-by-fda-to-produce-ryplazim/?widget=listSection
01 Jul 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/kedrion-selected-by-biotest-to-distribute-its-immunoglobulin-yimmugo-in-the-us-following-recent-fda-approval-302186408.html
29 Apr 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/kedrion-announces-rare-disease-medicine-ryplazim-now-available-in-us-302130342.html
07 Dec 2023
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https://www.prnewswire.com/news-releases/kedrion-announces-an-eight-year-extension-of-the-distribution-agreement-with-kamada-in-the-us-for-kedrab-302009137.html
25 Jul 2023
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https://www.prnewswire.com/news-releases/kedrion-biopharma-announces-support-for-the-immune-deficiency-foundation-research-grant-program-for-second-consecutive-year-301885635.html
12 Jul 2023
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https://www.prnewswire.com/news-releases/kedrions-global-portfolio-expands-to-china-to-supply-human-albumin-301875789.html
Details:
The commercial agreement includes potential expansion of Kedrion's distribution of Kedrab, a Human Rabies Immune Globulin, in additional territories beyond the US. In addition, the two companies will collaborate to expand distribution of Kedrion products by Kamada in Israel.
Lead Product(s): Rabies Immune Globulin (Human)
Therapeutic Area: Infections and Infectious Diseases Brand Name: Kedrab
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Kamada
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 07, 2023
Lead Product(s) : Rabies Immune Globulin (Human)
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Kamada
Deal Size : Undisclosed
Deal Type : Agreement
Details : The commercial agreement includes potential expansion of Kedrion's distribution of Kedrab, a Human Rabies Immune Globulin, in additional territories beyond the US. In addition, the two companies will collaborate to expand distribution of Kedrion products...
Brand Name : Kedrab
Molecule Type : Large molecule
Upfront Cash : Undisclosed
December 07, 2023
Details:
The agreement aims for the distribution of Kedrab (Rabies Immune Globulin [Human]), which is indicated for passive, transient post-exposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid, in the U.S.
Lead Product(s): Human Rabies Immune Globulin
Therapeutic Area: Immunology Brand Name: Kedrab
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Kamada
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 12, 2023
Lead Product(s) : Human Rabies Immune Globulin
Therapeutic Area : Immunology
Highest Development Status : Approved
Recipient : Kamada
Deal Size : Undisclosed
Deal Type : Agreement
Kamada Announces Kedrion Exercised its Option for Two-Year Extension of KEDRAB® Distribution Agre...
Details : The agreement aims for the distribution of Kedrab (Rabies Immune Globulin [Human]), which is indicated for passive, transient post-exposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid, in the U...
Brand Name : Kedrab
Molecule Type : Large molecule
Upfront Cash : Undisclosed
July 12, 2023
Details:
With the acquisition of Prometic, Kedrion has finalized a series of transactions with the announcement that it was acquiring the plasma purification plant at Laval in Québec, and the license to distribute the new product called Ryplazim in the United States.
Lead Product(s): Plasminogen
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ryplazim
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Kedrion
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 18, 2021
Lead Product(s) : Plasminogen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Kedrion
Deal Size : $17.0 million
Deal Type : Acquisition
Kedrion Biopharma Grows in North America As it Completes Acquisition of Prometic
Details : With the acquisition of Prometic, Kedrion has finalized a series of transactions with the announcement that it was acquiring the plasma purification plant at Laval in Québec, and the license to distribute the new product called Ryplazim in the United St...
Brand Name : Ryplazim
Molecule Type : Large molecule
Upfront Cash : Undisclosed
October 18, 2021
Details:
The primary efficacy objective of KIDCARES10 is to assess the efficacy of KIg10 administered to patients with PI to demonstrate that the rate of acute serious bacterial infections is less than 1.0 to provide substantial evidence of efficacy from day 1 to week 51/52.
Lead Product(s): Kedrion IVIG
Therapeutic Area: Immunology Brand Name: KIg10
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2021
Lead Product(s) : Kedrion IVIG
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
First Patient Treated in KIDCARES10, Kedrion Biopharma Pediatric Primary Immunodeficiency Study
Details : The primary efficacy objective of KIDCARES10 is to assess the efficacy of KIg10 administered to patients with PI to demonstrate that the rate of acute serious bacterial infections is less than 1.0 to provide substantial evidence of efficacy from day 1 to...
Brand Name : KIg10
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 13, 2021
Details:
This acquisition would include the Ryplazim® (plasminogen, human-tvmh) (“Ryplazim®”) business operated through its subsidiaries, Prometic Bioproduction Inc., the Company’s plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Brand Name: Ryplazim
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Prometic Biotherapeutic
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Agreement June 23, 2021
Lead Product(s) : Plasminogen
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Prometic Biotherapeutic
Deal Size : $17.0 million
Deal Type : Agreement
Details : This acquisition would include the Ryplazim® (plasminogen, human-tvmh) (“Ryplazim®”) business operated through its subsidiaries, Prometic Bioproduction Inc., the Company’s plasma-derived therapeutics manufacturing facility (“PBP”), and Promet...
Brand Name : Ryplazim
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 23, 2021
Details:
Kedrion will enter into an option agreement with Liminal BioSciences to acquire the remainder of the company’s plasma-derived business, as well as Plasminogen business operated through its subsidiaries including Prometic Biotherapeutics which holds the BLA for Ryplazim.
Lead Product(s): Plasminogen
Therapeutic Area: Genetic Disease Brand Name: Ryplazim
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Liminal BioSciences
Deal Size: $22.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 17, 2021
Lead Product(s) : Plasminogen
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Recipient : Liminal BioSciences
Deal Size : $22.0 million
Deal Type : Acquisition
Details : Kedrion will enter into an option agreement with Liminal BioSciences to acquire the remainder of the company’s plasma-derived business, as well as Plasminogen business operated through its subsidiaries including Prometic Biotherapeutics which holds the...
Brand Name : Ryplazim
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 17, 2021
Details:
According to terms and conditions, the Option would grant Kedrion the right to acquire all of the shares of PBP and PBT and would entitle Liminal BioSciences to receive up to seventy percent of the net proceeds, if granted, associated with a potential FDA approval of Ryplazim.
Lead Product(s): Plasminogen
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ryplazim
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Kedrion
Deal Size: $17.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 17, 2021
Lead Product(s) : Plasminogen
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Kedrion
Deal Size : $17.0 million
Deal Type : Acquisition
Kedrion enters into Agreement with Liminal BioSciences
Details : According to terms and conditions, the Option would grant Kedrion the right to acquire all of the shares of PBP and PBT and would entitle Liminal BioSciences to receive up to seventy percent of the net proceeds, if granted, associated with a potential FD...
Brand Name : Ryplazim
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 17, 2021
Details:
Objectives of KIDCARES10 Study, a phase III, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI).
Lead Product(s): Kedrion IVIG
Therapeutic Area: Immunology Brand Name: KIg10
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Lead Product(s) : Kedrion IVIG
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
KIDCARES10, First Patient Enrolled in Pediatric PI Study
Details : Objectives of KIDCARES10 Study, a phase III, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency d...
Brand Name : KIg10
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 31, 2021
Details:
The study of KEDRAB® (Rabies Immune Globulin [Human]) conducted in children was the first and only pediatric study for any HRIG available in U.S. The study met its primary objective, which was to confirm the safety of KEDRAB in the pediatric population.
Lead Product(s): Rabies Immune Globulin [Human]
Therapeutic Area: Infections and Infectious Diseases Brand Name: Kedrab
Study Phase: Phase IVProduct Type: Vaccine
Recipient: Kamada
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Lead Product(s) : Rabies Immune Globulin [Human]
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Recipient : Kamada
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The study of KEDRAB® (Rabies Immune Globulin [Human]) conducted in children was the first and only pediatric study for any HRIG available in U.S. The study met its primary objective, which was to confirm the safety of KEDRAB in the pediatric population.
Brand Name : Kedrab
Molecule Type : Vaccine
Upfront Cash : Not Applicable
August 19, 2020
Details:
Kedrion will supply convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the plasma against viral proteins to check the neutralizing power of the hyperimmune Immunoglobins.
Lead Product(s): Anti-COVID IgG therapy
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Columbia University
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 21, 2020
Lead Product(s) : Anti-COVID IgG therapy
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Columbia University
Deal Size : Undisclosed
Deal Type : Partnership
Details : Kedrion will supply convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the plasma against viral proteins to check the neutralizing power of the hyperimmune Im...
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
July 21, 2020
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