On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. Commissioner Makary’s comments build on sentiments expressed across both the patient community and industry that rare disease drug development needs greater regulatory flexibility in order to…
To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read…
Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies. In the following sections, we analyze data and trends in securities class actions across all industries and in the life sciences industry in…
Michael Siekman, Huiya Wu, Allegra Padula, and Riley Wyberg will present their data-driven analyses of trends in BPCIA litigation and relevant takeaways. With 10 years of litigation since the first BPCIA complaint on NEUPOGEN (filgrastim) was filed in 2014, trends are becoming apparent that should cause all biopharma companies to…
Arman Oruc, Andy Lacy, Sarah Jordan, and Stephen Mavroghenis are excited to invite you to join Goodwin for an in-person, engaging discussion on antitrust in life sciences transactions, navigating global merger control investigations and what to do when your deal hits a regulatory brick wall. We’ll cover the latest trends in early-stage deals,…
Attendees at this year’s symposium were optimistic about the potential for progress, citing momentum from new FDA initiatives, growing legislative support, and increased global innovation in research and development. These efforts, alongside increased patient advocacy and a presidential administration focused on speeding patient access, could lead to significant advances in…
The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close scrutiny and culminating most notably in the issuance of a complaint against the leading pharmacy…
Medtech mergers and acquisitions (M&A) and venture capital (VC) showed signs of life in 2024, contributing to an overall optimistic outlook for the sector this year despite lingering headwinds. Strategic investments are expected to continue as medtech companies innovate, particularly in areas such as AI-driven diagnostics, wearables and remote monitoring…
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…
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming months and years is emerging. Anticipated changes span multiple regulatory fronts: a revamped approach to antitrust review at the Federal…