Marinus Pharmaceuticals, Inc.
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Latest From Marinus Pharmaceuticals, Inc.
Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy.
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
The company will launch Ztalmy for an ultra-rare pediatric seizure disorder but hopes to expand to larger indications in the future. CEO Scott Braunstein talks to Scrip about the launch.
Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL
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