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Drug Approvals

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Latest From Approvals

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Lusutrombopag Shionogi for treating severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

Europe Approvals

J&J’s Esketamine: A Model “Breakthrough” Program For US FDA

J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.

Review Pathway Approvals

Leaving On A High Note: US FDA Commissioner’s Departure Fits A Pattern

Scott Gottlieb is leaving after a record number of drug approvals. If history is any guide, his successor will likely preside over a dip in output.
Approvals FDA

Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial

Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.

Approvals Drug Approval Standards

EU ‘Repurposing’ Project Plans Pilot Phase

A dedicated working group is taking forward a drug repurposing proposal originally devised by European industry bodies, with a view to determining the procedures to be used and running a pilot project with individual drug candidates.
Research and Development Strategies Regulation
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