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
Goodwin Procter Blogs
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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.
Acting
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based tools.
The guidance
FDIC Announces $1.775 Million Settlement with Arkansas-Based Bank and Employees
On May 17, 2024, the Federal Deposit Insurance Corporation (FDIC) announced a settlement with an Arkansas bank and nine of its employees, resolving allegations that the bank and the employees violated Section 5 of the Federal Trade Commission Act (FTC Act), Section 8 of the Real Estate Settlement Procedures Act (RESPA), the Fair Credit Reporting Act (FCRA),
CFPB and European Commission Release Report Regarding “Critical” Priority Areas for Consumer Financial Protection Issues
In April 2024, the Consumer Financial Protection Bureau (CFPB or Bureau) and the Commissioner for Justice and Consumer Protection of the European Commission (European Commission) announced that three meetings had been convened with senior staff and subject matter experts to discuss “shared priority areas” of concern for consumer financial protection issues. The CFPB and the