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.

Legal 500 Editorial commentary

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.

Lawyers

Practice head

The lawyer(s) leading their teams.

Fran Stoller, Mark Waddell, Jim Czaban, Mitchell Nussbaum

Other key lawyers

Kathleen Gersh