Participants in the life sciences sector operate in an increasingly challenging environment that requires a broad spectrum of sophisticated legal services. Our group counsels emerging and mature companies, investors, and investment banks in areas ranging from financing and venture capital to intellectual property, FDA regulatory and sales and marketing compliance, mergers and acquisitions, licensing, employment, litigation, antitrust, product liability, and other general commercial and clinical matters relevant to the life sciences industry. The team–including former in-house counsel from large and midsize pharmaceutical, medical device, and biotech companies–anticipates and efficiently addresses client needs.
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Centivo, a new type of self-funded health plan, in its $34 million Series A financing led by Bain Capital Ventures, with additional investments from F-Prime Capital Partners, Maverick Ventures, Bessemer Venture Partners, Ingleside Investors, Rand Capital, Grand Central Tech Ventures, and Oxeon Investments.
Aetion, Inc. in its $36.4 million Series B financing, in a round led by New Enterprise Associates (NEA) and including, as a new investor, Amgen Ventures, alongside existing investors Flare Capital Partners, Lakestar, and Oxeon Ventures. We previously represented Aetion in is $11.2 million Series A financing led by Flare Capital Partners and joined by Lakestar.
Pink Sheet quotes James C. Shehan in an article reporting pharmaceutical company Sanofi’s settlement with the U.S. Securities and Exchange Commission for violating the Foreign Corrupt Practices Act (FCPA). The article notes that this settlement follows a relatively quiet period for FCPA settlements. Shehan attributes the lack of FCPA enforcement activity to the fact that “there are fewer easy cases out there for prosecutors to go after,” that there can be a long period between the alleged violation and resolution of the case, and that companies have generally become more compliant with the law. (subscription required to access article)
Law360 interviews with James C. Shehan on a broad range of issues, including: critical skills for being a successful FDA lawyer, a move to streamline the FDA’s approval process, patent litigation involving biosimilars, FDA updates to off-label promotion guidance, a push in favor or competition and generics, and understanding why the FDA has reduced the number of warning and untitled letters for promotional issues. (subscription required to access article)
Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)
Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.
James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.