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            Lead Product(s): Risdiplam

            Therapeutic Area: Neurology Product Name: Evrysdi

            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 16, 2020

            Details:

            The application is based on the results from two positive studies evaluating risdiplam in Types 1, 2 and 3 spinal muscular atrophy across infants and adults.

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            Lead Product(s): Perampanel

            Therapeutic Area: Neurology Product Name: Fycompa

            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 16, 2020

            Details:

            The submission covering partial-onset seizures in pediatric patients was based on the results of a Phase III study of Fycompa as an adjunctive therapy conducted globally on pediatric patients with uncontrolled partial onset seizures/primary generalized tonic-clonic seizures.

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            Lead Product(s): Edaravone

            Therapeutic Area: Neurology Product Name: Radicava

            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 September 30, 2020

            Details:

            MTPA will present details on the REFINE-ALS study, assessing RADICAVA® (edaravone), for which MTPA aims to identify and measure specific biomarkers and clinical assessments in people with ALS.

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            Lead Product(s): Perampanel

            Therapeutic Area: Neurology Product Name: Fycompa

            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 September 23, 2020

            Details:

            The positive opinion is to extend the use of Fycompa as an adjunctive therapy for partial-onset seizures by expanding the approved age range from 12 years & above to 4 years & above, and for primary generalized tonic-clonic seizures from 12 years & above to 7 years & above.

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            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Equfina

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Eisai

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 07, 2020

            Details:

            Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.

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            Lead Product(s): Satralizumab-mwge

            Therapeutic Area: Neurology Product Name: Enspryng

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 26, 2020

            Details:

            Enspryng is the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody created by Chugai. In Japan, the product received manufacturing and marketing approval on June 29, 2020, and was listed on the National Health Insurance (NHI) reimbursement price list today.

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            Lead Product(s): Edaravone

            Therapeutic Area: Neurology Product Name: MT-1186

            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:

            Global Phase 3 study to evaluate the long-term safety and tolerability of an investigational oral suspension formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS) has resumed screening and enrollment.

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            Lead Product(s): Satralizumab-mwge

            Therapeutic Area: Neurology Product Name: Enspryng

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2020

            Details:

            SAkuraSky is a study to evaluate Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar is a study to evaluate Enspryng as monotherapy.

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            Lead Product(s): Fremanezumab

            Therapeutic Area: Neurology Product Name: Ajovy

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 29, 2020

            Details:

            Fremanezumab is an anti-CGRP monoclonal antibody, administered as a subcutaneous injection for the prevention of chronic and episodic migraine attacks. NDA has been applied for the indication of preventive treatment of migraine.

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            Lead Product(s): Edaravone

            Therapeutic Area: Neurology Product Name: Radicava

            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 July 07, 2020

            Details:

            Mitsubishi Tanabe Pharma Canada announced today that RADICAVA® (edaravone), an infusion treatment for amyotrophic lateral sclerosis (ALS), is now listed on the Nova Scotia Formulary (special authorization).

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