Loeb & Loeb LLP combines expertise in FDA regulatory issues with a specialization in patent litigation, advising clients on the marketing and commercialization of their drugs and representing them in patent disputes, including those falling under Hatch-Waxman. Washington DC-based Jim Czaban takes the lead on FDA compliance across the life cycle of medical products and representing them in enforcement actions. Mitchell Nussbaum handles a range of corporate and capital markets matters, with Fran Stoller on research collaborations, licensing agreements and securities law. Mark Waddell represents clients in Hatch-Waxman and biosimilars litigation, as does Kathleen Gersh, who also advises on FDA regulation. Unless otherwise specified, all lawyers are New York-based.
Testimonials
Collated independently by Legal 500 research team.
- 'Outstanding SEC filing, FDA regulatory, and IP expertise.'
Key clients
- Genentech, Inc./InterMune, Inc.
- JATT Acquisition Corp.
- Rosemont Pharmaceuticals Ltd.
- Swiftmerge Acquisition Corp.
- Health Sciences Acquisitions Corporation 2
- QVC/Home Shopping Network
- ThinkEquity
- Maxim Group LLC
- MAIA Biotechnology, Inc.
- Liminatus Pharma LLC
- Redwoods Acquisition Corp.
Work highlights
- Represented Liminatus Pharma LLC in its merger with Iris Acquisition Corp.
- Advised Rosemont Pharmaceuticals on FDA issues regarding prescription drug product development strategies.
Practice head
The lawyer(s) leading their teams.
Fran Stoller, Mark Waddell, Jim Czaban, Mitchell Nussbaum