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.
We have been described as "beyond responsive"–we care deeply about our clients and see their day-to-day battles as our own. Our broad industry practice representing emerging companies, multinational publicly traded companies, venture funds, hedge funds, private equity firms, and life sciences-focused investment banks gives us insight into industry dynamics and helps us develop creative solutions to complex legal issues.
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.
Represented Regulatory Professionals, Inc., a global integrated regulatory outsourcing providers to the pharmaceutical, biopharmaceutical, and medical device industries, in its acquisition by Premier Research, a global provider of clinical development services to biopharmaceutical product innovators. (July 2018)
James C. Shehan is quoted in the Pink Sheet regarding Sarepta Therapeutics Inc.’s decision to not publicly disclose its submission of a formal dispute resolution request appealing the FDA’s rejection of the drug Vyondys 53. Shehan notes that the legal standard for determining whether information such as this must be disclosed is how material is it to an investor’s buy or sell decision and that, because companies don't often win formal dispute resolutions with the FDA, Sarepta’s decision to not disclose the appeal’s existence could be legally permissible. (subscription required to access article)
James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, is interviewed on the “Not So Different” podcast by the Center for Biosimilars on the FDA’s recently released final guidelines on demonstrating interchangeability, which Shehan knows well because he helped craft the sections of the Biologics Price Competition and Innovation Act that govern interchangeability. He also addresses the upcoming transition of insulin to its regulation as a biologic instead of as a drug, and the possibility of it being categorized as an interchangeable one day.
A video interview with James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, on the FDA’s new approach to citizen petitions aimed at delaying market entry of products, was published on the CenterForBiosimilars.com. Shehan explains that the agency has issued more details on the criteria it will use in deciding whether a petition’s primary purpose is to delay generic competition.
James C. Shehanis quoted in CenterForBiosimilars.com, BioPharma Dive, and Modern Healthcarediscussing what the biosimilars industry will look like once FDA Commissioner Scott Gottlieb, MD steps down this April. Shehan notes that Gottlieb represented “a quantum leap in terms of activism” and “has gotten far and away the highest job marks of any commissioner we’ve seen, particularly when you consider that he has gotten respect across the board, which is unusual”, further noting the change in approach to the biosimilars market Gottlieb has taken during his tenure at the FDA resulting in a more competitive drug market. Shehan observes that Gottlieb’s legacy will encourage his successors to “be more communicative with the public and more willing to take a role in some of the great public health controversies”, he further provides that the industry’s concern is rooted in the uncertainty of who the next commissioner will be and if he or she will be able to keep this positive action going.
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.