Medical Device Deals Update, February 2016
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Medical Device Deals Update column is a survey of recent medtech M&A, alliance, and financing activity. This month’s column covers deals announced December 2015-January 2016.
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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.
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.
Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.