Deals Update
Executive Summary
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court
In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.
Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA
Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.
New EU Filings
Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.