AbbVie Submits Regulatory Application to FDA for Subcutaneous SKYRIZI
On April 27, 2026, AbbVie announced that it has submitted a regulatory application to the FDA seeking approval for SKYRIZI (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn’s disease. AbbVie states that its application is supported by positive data
Goodwin Procter Blogs
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Shareholder Proposals and ESG at a Crossroads: What Boards Should Know After the 2026 Proxy Season
The Weinberg Center’s fifth annual “ESG in the Boardroom” program, titled “Shareholder Proposals at the Crossroads: Boards, ESG, and the Future of SEC Rule 14a-8,” held April 28 in Wilmington, Delaware, brought together directors, jurists, advisors, and regulators to examine a governance environment in which boards are operating with less regulatory certainty and more direct
SEC Chairman Atkins on AI: Strategy, Governance, and the Discipline of Principles
On March 4, 2026, SEC Chairman Paul S. Atkins delivered remarks at the Financial Stability Oversight Council’s Artificial Intelligence Innovation Series Roundtable on Strategy and Governance Principles, outlining how the Commission is approaching artificial intelligence as both a regulatory tool and a market development. In his remarks, Chairman Atkins addressed the implications of AI for
Quick Takes from SRI 2026
At this year’s SRI, a few themes popped up in panels across a range of topics: disclosure trends; governance priorities; and frequently discussed interpretive questions.
IPO Comment Letter Timing: Still Long, but Improving
Initial comment letters for IPOs are still currently taking longer than the 30-day target reflective of both filing volume and working down
Year in Review: Big Deals of 2025
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars.
Antibody Therapy Deals
Novartis acquires Avidity Biosciences
On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced that they had entered into
SEC Announces Creation of Task Force on Artificial Intelligence
On August 1, 2025, the Securities and Exchange Commission (SEC) announced the launch of a task force on artificial intelligence (AI) that will spearhead the agency’s efforts to enhance innovation and efficiency in its operations through the responsible use of AI. Valerie Szczepanik, who has been named the SEC’s Chief AI Officer, is leading the
ISS Launches Annual Global Benchmark Policy Survey
On July 24, 2025, Institutional Shareholder Services (ISS) announced the launch of its Annual Global Benchmark Policy Survey. In its announcement, ISS notes:
This year’s survey begins with core governance topics, including shareholder rights in relation to multi-class capital structures, considerations with regard to shareholder proposals, and board governance, with a focus on director overboarding.
AI & Drug Discovery Symposium: Revolutionizing the Future of Medicine
Jumpstart your week with a deep dive into the future of medicine as part of Goodwin’s exclusive programming during the BIO International Convention in Boston. Join us for a dynamic symposium where industry leaders and AI pioneers come together to unveil how artificial intelligence is revolutionizing drug discovery. Don’t miss this chance to explore groundbreaking
FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them “with more effective, human-relevant methods.” According to the FDA, the “animal testing requirement will be reduced, refined, or potentially replaced
SEC Announces Creation of Cyber and Emerging Technologies Unit
On February 20, 2025, the SEC announced the creation of the Cyber and Emerging Technologies Unit (CETU) “to focus on combatting cyber-related misconduct and to protect retail investors from bad actors in the emerging technologies space.” The CETU’s focus on protecting retail investors harkens back to similar SEC initiatives under former SEC Chairman Jay Clayton.
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