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- June 2023 (Revised July 2024)
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
- December 2022 (Revised August 2023)
- Case
Ribbit Capital and the Gauntlet Investment Opportunity
By: Shai Bernstein and Allison M. Ciechanover
Ten-year-old, Palo Alto-based Ribbit Capital is best-known for its global investments in fintech. The firm was also an early advocate of crypto and blockchain, having invested in more than two dozen startups in the space in the past decade. In the Spring of 2022,... View Details
Keywords: Alternative Assets; Cryptocurrency; Business Startups; Investment Portfolio; Decision Choices and Conditions; Negotiation Deal; Governing Rules, Regulations, and Reforms; Venture Capital; Financial Services Industry; California
Bernstein, Shai, and Allison M. Ciechanover. "Ribbit Capital and the Gauntlet Investment Opportunity." Harvard Business School Case 823-038, December 2022. (Revised August 2023.)
- November 2001
- Case
Aventis CropScience and StarLink Corn
By: Ray A. Goldberg and James M Beagle
Aventis CropScience responds to the discovery of an unapproved corn variety in food supplies and draws lessons for the company, industry, and governments. View Details
- 01 Oct 2015
- Working Paper Summaries
Efficiencies and Regulatory Shortcuts: How Should We Regulate Companies like Airbnb and Uber?
- 2019
- Book
Fintech, Small Business & the American Dream: How Technology Is Transforming Lending and Shaping a New Era of Small Business Opportunity
By: Karen G. Mills
Fintech, Small Business & the American Dream describes the needs of small businesses for capital and demonstrates how technology—novel data sources, artificial intelligence, machine learning—will transform the small business lending market. This market has been... View Details
Keywords: Fintech; Big Data; Data; Technology; Artificial Intelligence; Great Recession; Regulation; Innovation; Banks; Lending; Loans; Access To Capital; American Dream; Community Banking; Small Business Administration; Entrepreneur; Government; Public Policy; API; Policy Making; Small Business; Financing and Loans; Technological Innovation; Financial Crisis; Banks and Banking; Governing Rules, Regulations, and Reforms; Policy; AI and Machine Learning; Analytics and Data Science; United States
Mills, Karen G. Fintech, Small Business & the American Dream: How Technology Is Transforming Lending and Shaping a New Era of Small Business Opportunity. Palgrave Macmillan, 2019.
- December 2020 (Revised February 2021)
- Supplement
The Tulsa Massacre and the Call for Reparations
By: Mihir A. Desai and Suzanne Antoniou
How should historic social injustices be addressed? Survivors of the 1921 Tulsa Massacre and their descendants, including Representative Regina Goodwin of Tulsa, believe they should be addressed through reparations and have consequently continued to push the government... View Details
Keywords: Cost vs Benefits; Decision Choices and Conditions; Decisions; Judgments; Race; Fairness; Moral Sensibility; Values and Beliefs; Corporate Accountability; Corporate Governance; Policy; Governing Rules, Regulations, and Reforms; Government Legislation; Government and Politics; Government Administration; Lawsuits and Litigation; Legal Liability; Leading Change; Mission and Purpose; Corporate Social Responsibility and Impact; Conflict and Resolution; Conflict Management; Loss; Motivation and Incentives; Perspective; Prejudice and Bias; Civil Society or Community; Social Issues; Welfare; Tulsa; Oklahoma; United States
- 2019
- Working Paper
Understanding and Overcoming Roadblocks to Environmental Sustainability. Past Roads and Future Prospects
By: Ann-Kristin Bergquist, Shawn A. Cole, John Ehrenfeld, Andrew A. King and Auden Schendler
This working paper examines key barriers to business sustainability discussed at a multidisciplinary conference held at the Harvard Business School in 2018. Drawing on perspectives from both the historical and business literatures, speakers debated the historical... View Details
Keywords: Environmental Sustainability; Problems and Challenges; History; Governing Rules, Regulations, and Reforms; Opportunities
Bergquist, Ann-Kristin, Shawn A. Cole, John Ehrenfeld, Andrew A. King, and Auden Schendler. "Understanding and Overcoming Roadblocks to Environmental Sustainability. Past Roads and Future Prospects." Harvard Business School Working Paper, No. 19-067, January 2019.
- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details
Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 17 Aug 2021
- Op-Ed
Dispensing Justice: The Case for Legalizing Cannabis Nationally
Last month, US Senate Majority Leader Charles Schumer and senators Cory Booker and Ron Wyden introduced draft legislation to legalize cannabis federally. Some commentators say that by expunging federal,... View Details
Keywords: by Ashish Nanda and Tabatha Robinson
- September 2023
- Case
The Rise and Fall of FTX
In November 2022, Sam Bankman-Fried's multi-billion-dollar crypto exchange, FTX, collapsed, wiping out investors and throwing the crypto industry into disarray. As FTX's founder and CEO, Bankman-Fried developed a reputation for his unerring business sense and... View Details
Keywords: Cryptocurrency; Crime and Corruption; Financial Statements; Misleading and Fraudulent Advertising; Insolvency and Bankruptcy; Corporate Governance; Governing Rules, Regulations, and Reforms; Failure; Restructuring; United States; Hong Kong; Bahamas
Dey, Aiyesha, Jonas Heese, Joseph Pacelli, and Max Hancock. "The Rise and Fall of FTX." Harvard Business School Case 124-014, September 2023.
- 2018
- Chapter
Between Economic Planning and Market Competition: International Law and Economics in the U.S.
By: Laura Phillips Sawyer
The impact of institutional economics in shaping the American regulatory tradition has largely been dismissed as an incoherent attack on the neoclassical economic paradigm. This essay briefly reconstructs the interwar institutionalist movement, exploring the... View Details
Keywords: Economics; History; Governing Rules, Regulations, and Reforms; Business and Government Relations; United States
Phillips Sawyer, Laura. "Between Economic Planning and Market Competition: International Law and Economics in the U.S." In New Perspectives on the History of Political Economy, edited by Robert Fredona and Sophus A. Reinert, 349–374. New York: Palgrave Macmillan, 2018.
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- February 2025
- Case
Abiomed: Clinical Trials and Tribulations
By: Satish Tadikonda, Faith Robertson and William Marks
After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial... View Details
Keywords: Corporate Disclosure; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Launch; Medical Devices and Supplies Industry
Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: Clinical Trials and Tribulations." Harvard Business School Case 825-096, February 2025.
- October 2023
- Article
Laboratory Safety and Research Productivity
By: Alberto Galasso, Hong Luo and Brooklynn Zhu
Are laboratory safety practices a tax on scientific productivity? We examine this question by exploiting the substantial increase in safety regulations at the University of California following the shocking accidental death of a research assistant in 2008.... View Details
Keywords: Economics Of Science; Risk Perception; Safety Regulations; Governing Rules, Regulations, and Reforms; Working Conditions; Safety; Performance Productivity
Galasso, Alberto, Hong Luo, and Brooklynn Zhu. "Laboratory Safety and Research Productivity." Art. 104827. Research Policy 52, no. 8 (October 2023).
- December 2007
- Article
Learning to Live with Governments: Unilever in India and Turkey, 1950-1980
By: G. Jones
A noteworthy characteristic of the contemporary global economy is the uneven distribution of world foreign direct investment (FDI). In 2007 three-quarters of world FDI was located in developed countries. The residual was concentrated in a small number of emerging... View Details
Keywords: Developing Countries and Economies; Ethics; Foreign Direct Investment; Governing Rules, Regulations, and Reforms; Business and Community Relations; Business and Government Relations; Consumer Products Industry; India; Turkey
Jones, G. "Learning to Live with Governments: Unilever in India and Turkey, 1950-1980." Entreprises et histoire 49 (December 2007).
- 13 Jan 2016
- Working Paper Summaries
Forward Guidance in the Yield Curve: Short Rates versus Bond Supply
- Forthcoming
- Book
Blockchain Forensics and Crypto-Related Cybercrimes
By: Lin William Cong, Kim Grauer, Daniel Rabetti and Henry Updegrave
This handbook provides an overview of various criminal activities related to cryptocurrencies, including investment scams, Ponzi schemes, rug pulls, ransomware attacks, money laundering, and darknet markets. We discuss the need for user protection and education,... View Details
Keywords: Cyberattacks; Blockchain; Network; Cryptocurrency; Crime and Corruption; Cybersecurity; Governing Rules, Regulations, and Reforms; Law Enforcement; Technology Adoption
Cong, Lin William, Kim Grauer, Daniel Rabetti, and Henry Updegrave. Blockchain Forensics and Crypto-Related Cybercrimes. World Scientific Publishing, forthcoming.
- November 2023
- Case
Will Fintechs and Central Banks Play in Emtech's Sandbox?
By: Daniel Isenberg and William R. Kerr
In February 2023, Emtech’s founder Carmelle Cadet is facing a dilemma. Rapidly running out of cash, Cadet has a term sheet from a leading VC but has a choice of how to structure the investment. The decision will have significant implications for Cadet’s own stake, as... View Details
Keywords: Cryptocurrency; Business Startups; Venture Capital; Cash Flow; Currency; Governing Rules, Regulations, and Reforms; Digital Platforms
Isenberg, Daniel, and William R. Kerr. "Will Fintechs and Central Banks Play in Emtech's Sandbox?" Harvard Business School Case 824-096, November 2023.
- 2011
- Working Paper
Fiduciary Duties and Equity-Debtholder Conflicts
By: Bo Becker and Per Stromberg
We use an important legal event as a natural experiment to examine the effect of management fiduciary duties on equity-debt conflicts. A 1991 Delaware bankruptcy ruling changed the nature of corporate directors' fiduciary duties in firms incorporated in that state.... View Details
Keywords: Borrowing and Debt; Capital Structure; Equity; Insolvency and Bankruptcy; Governing Rules, Regulations, and Reforms; Laws and Statutes; Conflict and Resolution; Welfare or Wellbeing; Delaware
Becker, Bo, and Per Stromberg. "Fiduciary Duties and Equity-Debtholder Conflicts." Harvard Business School Working Paper, No. 10-070, February 2010. (Revised June 2011, November 2011.)
- November 2010
- Teaching Note
Mexico: Crisis and Competitiveness (TN)
By: Richard H.K. Vietor and Aldo Musacchio
Teaching Note for 710058. View Details