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Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals' LupkynisTM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.
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Lead Product(s): Acetylcystein
Therapeutic Area: Immunology Product Name: FLEX 10
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Chemistree
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2021
Details:
FLEX 10™ is ImmunoFlex's unique N-Acetyl-L-cysteine formulation in packs of 30 - 600 mg capsules. FLEX 10TM is a powerful antioxidant, specifically packaged in aluminum blisters to reduce the potential for product oxidation.
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Lead Product(s): Voclosporin
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $100.0 million Upfront Cash: $50.0 million
Deal Type: Collaboration December 17, 2020
Details:
The aim of the collaboration is to develop and commercialize oral voclosporin for the treatment of lupus nephritis (LN) in the European Union (EU), Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, Ukraine and the United Kingdom.
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Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
KYE Pharmaceuticals announces FIRDAPSE® (amifampridine phosphate), the first amifampridine product approved in Canada, is now widely available for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
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Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 16, 2020
Details:
Aequus has agreed to an extension of terms for its promotional service agreement with Sandoz Canada Inc. on tacrolimus immediate-release Tacrolimus IR to December 31st, 2021.
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Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Ruzurgi
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Jacobus Pharmaceutical Company, Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
Médunik Canada has retained the services of Innomar, a leading specialty pharmaceutical service and patient support program provider, for the distribution of Ruzurgi® and management of its UnikAccess Patient Support Program.
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Lead Product(s): Triamcinolone Acetonide
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 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.
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Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Catalyst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 18, 2020
Details:
Under the terms of the agreement, Catalyst will supply Firdapse® to KYE and KYE will be responsible for promotion, sales, advertisement, marketing, product importation and distribution.
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Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
The allowed application, "Methods of Administering 3,4-Diaminopyridine", claims a method of treating a human patient diagnosed with a 3,4-DAP sensitive disease by administering 3,4-DAP to slow acetylating patients having certain mutations in each allele of the NAT2 gene.
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Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
The marketing application submitted to Health Canada included safety and efficacy data from Catalyst’s two previously reported multi-national clinical trials evaluating Firdapse® for the treatment of patients with LEMS.
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