Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

Shots:Dimerix has granted Amicus exclusive US rights to develop & market DMX-200 for all indications, incl. focal segmental glomerulosclerosis (FSGS), with Amicus handling regulatory filings, dossier maintenance, & marketing in the USDimerix will get $30M cash upfront, ~$75M on FDA approval, $35M on 1st sale, ~$40M for future indications & ~$410M in sales…

ByRidhi RastogiMay 1, 2025

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Insights+: EMA Marketing Authorization of New Drugs in June 2023

Shots:The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in June 2023, leading to treatments for patients and advances in the healthcare industryIn June 2023, the major highlights drugs were Jardiance approval for CKD patients, Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosisPharmaShots has compiled a list of a…

BySenior EditorJuly 28, 2023

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Insights+: EMA Marketing Authorization of New Drugs in April 2023

Shots:The EMA approved 8 New Chemical Entity (NCE) and 3 Biologic Drugs in April 2023, leading to treatments for patients and advances in the healthcare industryIn April 2023, the major highlights drugs were Rinvoq’s Approval for active Crohn's Disease, Opzelura for non-segmental vitiligo with facial involvement in adults and adolescentsPharmaShots has compiled…

BySenior EditorMay 25, 2023

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Insights+: EMA Marketing Authorization of New Drugs in March 2023

Shots:The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industryIn March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe diseasePharmaShots has compiled a…

BySenior EditorApril 27, 2023

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

Insights+: EMA Marketing Authorization of New Drugs in June 2023

Insights+: EMA Marketing Authorization of New Drugs in April 2023

Insights+: EMA Marketing Authorization of New Drugs in March 2023

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