Medical Device Deals Update, March 2012
A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.
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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.
The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.