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- All HBS Web
(490)
- People (1)
- News (131)
- Research (321)
- Multimedia (4)
- Faculty Publications (176)
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- 23 Jul 2013
- First Look
First Look: July 23
School Case 713-483 Yammer (B) Supplement to "Yammer (A)," HBS case 713-407 Purchase this case: http://hbr.org/search/713483-PDF-ENG Harvard Business School Case 712-466 Moving to Universal Coverage: Health Care View Details
Keywords: Anna Secino
- 29 Jan 2015
- Op-Ed
The Fall of Greece
Professor of Business Administration and a native of Greece, offers his insights into what the election means for the country. Many people ask me what the recent elections in Greece mean for the Greek economy. While I agree reforms are... View Details
Keywords: by George Serafeim
- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed... View Details
Keywords: COVID-19; Health Care and Treatment; Health Pandemics; Adoption; Behavior; Governing Rules, Regulations, and Reforms; Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- 2004
- Book
Pharmacopolitics: Drug Regulation in the United States and Germany
By: Arthur A. Daemmrich
Keywords: Health; Governing Rules, Regulations, and Reforms; Government and Politics; United States; Germany
Daemmrich, Arthur A. Pharmacopolitics: Drug Regulation in the United States and Germany. University of North Carolina Press, 2004. (Winner of Edward Kremers Award of the American Institute of the History of Pharmacy For best book in pharmaco-historical writing published in the previous two years presented by American Institute of the History of Pharmacy.)
- 11 Dec 2012
- First Look
First Look: Dec. 11
of Health Care Reform Oberholzer-Gee, Felix, Raffaella Sadun, and Richard G. HamermeshHarvard Business School Case 711-403 Per the Patient Protection and Affordable Care Act (PPACA), which President Obama... View Details
Keywords: Sean Silverthorne
- October 2024
- Article
Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates
By: Pragya Kakani, Michael Anne Kyle, Amitabh Chandra and Luca Maini
Medicare Part D does not allow plans to exclude drugs in six protected classes from their formularies, which may limit plans’ ability to negotiate rebates and lead to higher spending. We estimated the association between protected-class status, US-level estimated... View Details
Keywords: Insurance; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States
Kakani, Pragya, Michael Anne Kyle, Amitabh Chandra, and Luca Maini. "Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates." Health Affairs 43, no. 10 (October 2024): 1420–1427.
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a... View Details
Keywords: Biosimilars; Rebates; Pharmaceuticals; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- 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
- 2024
- Working Paper
Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the... View Details
Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 21-132, June 2021. (Revised May 2024.)
- 2024
- Working Paper
Coronary Artery Bypass Grafting—Impossible to Routine: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant M. Datar and Fabio Villa
We describe how Coronary Artery Bypass Grafting (CABG, or more popularly, “bypass”) operations
revolutionized the treatment of coronary disease (that can produce fatal heart attacks and debilitating
angina). Specifically, we chronicle the: 1) development of the... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Fabio Villa. "Coronary Artery Bypass Grafting—Impossible to Routine: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-010, July 2019. (Revised May 2024.)
- September 2009 (Revised August 2012)
- Case
Novasys Medical
By: Richard G. Hamermesh and Lauren Barley
Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the... View Details
Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Health Disorders; Product Development; Business and Government Relations; Medical Devices and Supplies Industry; United States
Hamermesh, Richard G., and Lauren Barley. "Novasys Medical." Harvard Business School Case 810-027, September 2009. (Revised August 2012.)
- 06 Oct 2015
- First Look
October 6, 2015
at the Narayana Health City Cardiac Hospital (NH) in India. The case discusses the factors driving the adoption of task shifting at NH and identifies the implications of task shifting for surgeon training, surgical capacity, and procedure... View Details
Keywords: Sean Silverthorne
- August 2023 (Revised May 2024)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details
Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry
Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)
- 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.
- 26 Jul 2016
- Working Paper Summaries
The Impact of the Entry of Biosimilars: Evidence from Europe
- 2023
- Article
Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control
By: Susanna Gallani
Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees... View Details
Keywords: Organizational Behavior Modification; Peer Monitoring; Persistence Of Performance Improvements; Crowding Out; Implicit Incentives; Compensation; Healthcare; Social Pressure; Image Motivation; Incentives; Motivation; Performance; Behavior; Motivation and Incentives; Compensation and Benefits; Governing Rules, Regulations, and Reforms; Organizational Culture; Health Industry; California
Gallani, Susanna. "Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control." Accounting Review 93, no. 3 (2023): 1–28.
- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
By: Michael Blank, Samuel G. Hanson, Jeremy C. Stein and Adi Sunderam
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that... View Details
Keywords: COVID-19; Bank Regulation; Recapitalization; Health Pandemics; Banks and Banking; Governing Rules, Regulations, and Reforms; Strategy; Risk Management; United States
Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of... View Details
Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 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.)
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).