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Show Results For
-
All HBS Web
(140)
- News (22)
- Research (108)
- Events (2)
- Multimedia (2)
- Faculty Publications (40)
- 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...
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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.
- December 2003
- Case
Antitrust Regulations in a Global Setting: The EU Investigation of the GE/Honeywell Merger
By: Mihir A. Desai, Belen Villalonga and Mark Veblen
Helps students understand the principles underlying competition and antitrust policy in the context of the proposed GE-Honeywell merger. The U.S. Department of Justice has already approved the transaction and it is being considered by the European Commission. The...
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Keywords:
Mergers and Acquisitions;
Decisions;
Economy;
Fairness;
Governing Rules, Regulations, and Reforms;
Competition;
Aerospace Industry
Desai, Mihir A., Belen Villalonga, and Mark Veblen. "Antitrust Regulations in a Global Setting: The EU Investigation of the GE/Honeywell Merger." Harvard Business School Case 204-081, December 2003.
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial...
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Keywords:
Market Entry and Exit;
Price;
Market Timing;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States;
Germany
Blankart, Katharina, Huseyin Naci, and Amitabh Chandra. "Availability of New Medicines in the U.S. and Germany From 2004 to 2018." e2229231. JAMA Network Open 5, no. 8 (August 2022).
A Radical Treatment for Insulin Pricing
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
- 10 Aug 2015
- Research & Ideas
New Medical Devices Get To Patients Too Slowly
implantable defibrillators or transcatheter heart valves, the FDA's regulatory approval process appears to delay those approvals, which in turn adds to development costs borne by device manufacturers,...
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- April 2021 (Revised December 2021)
- Case
The Carlyle Group: Carving Out Atotech
On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal team—Martin Sumner, Greg Nikodem, Tanaka Maswoswe...
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Keywords:
Oil & Gas;
Deal;
International Acquisition;
International;
Acquisition;
Negotiation Deal;
Transformation;
Chemicals;
Chemical Industry;
United States;
Europe;
Asia;
Germany
Kanter, Rosabeth Moss. "The Carlyle Group: Carving Out Atotech." Harvard Business School Case 321-153, April 2021. (Revised December 2021.)
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords:
Digital;
Medicine;
FDA;
Health Care and Treatment;
Applications and Software;
Safety;
Cybersecurity;
Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- December 2008 (Revised October 2013)
- Case
Amylin Pharmaceuticals: Diabetes and Beyond (A)
By: Richard G. Hamermesh and Rachel Gordon
Ginger Graham, CEO of Amylin Pharmaceuticals, joined the company with the expectation of taking the company's signature drug, Symlin, to market. However, unforeseen regulatory challenges have put the approval process in jeopardy. At the same time, the company has a...
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Keywords:
Regulations;
Drug Regulations;
Symlin;
Negotiation;
Governing Rules, Regulations, and Reforms;
Resource Allocation;
Negotiation Deal;
Product Development;
Research and Development;
Commercialization;
Pharmaceutical Industry;
United States
Hamermesh, Richard G., and Rachel Gordon. "Amylin Pharmaceuticals: Diabetes and Beyond (A)." Harvard Business School Case 809-011, December 2008. (Revised October 2013.)
- December 2019
- Technical Note
Technical Note on Bayesian Statistics and Frequentist Power Calculations
By: Amitabh Chandra and Ariel Dora Stern
This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’...
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Chandra, Amitabh, and Ariel Dora Stern. "Technical Note on Bayesian Statistics and Frequentist Power Calculations." Harvard Business School Technical Note 620-032, December 2019.
- 20 Dec 2016
- First Look
December 20, 2016
to creating your own model. Publisher's link: https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=52002 January 2017 Journal of Public Economics Innovation Under Regulatory Uncertainty: Evidence from Medical Technology By: Stern, Ariel Dora...
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Keywords:
Carmen Nobel
- 2012
- Other Unpublished Work
The Efficacy of Shareholder Voting: Evidence from Equity Compensation Plans
By: Ian D. Gow, Christopher S. Armstrong and David F. Larcker
This study examines the effects of shareholder support for equity compensation plans on subsequent chief executive officer (CEO) compensation. Using cross-sectional regression, instrumental variable, and regression discontinuity research designs, we find little...
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- Forthcoming
- Article
Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms
By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Product Development;
Health Testing and Trials;
Governing Rules, Regulations, and Reforms
Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics (forthcoming). (Pre-published online February 2, 2024.)
- July 2021
- Teaching Note
The Carlyle Group: Carving Out Atotech
Teaching Note for HBS Case No. 321-153. On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal...
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- January 2009 (Revised July 2009)
- Case
Targanta Therapeutics: Hitting a Moving Target
By: Arthur A. Daemmrich
This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful...
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Keywords:
Decision Choices and Conditions;
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Business and Government Relations;
Business Strategy;
Biotechnology Industry;
Pharmaceutical Industry
Daemmrich, Arthur A. "Targanta Therapeutics: Hitting a Moving Target." Harvard Business School Case 709-002, January 2009. (Revised July 2009.)
- 05 May 2003
- Research & Ideas
Greed, Fear, and The System Hinder Corporate Reform
Enforcers of regulatory laws are making some headway, particularly since the passage last summer of the Sarbanes-Oxley Act, but their work as a whole needs more teeth, according to panelists at the session on regulation and enforcement....
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Keywords:
by Martha Lagace
- 17 Apr 2014
- HBS Seminar
Paul Healy, Harvard Business School
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
December 19, 2018 NEJM Catalyst It's Time to Reform the Orphan Drug Act By: Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—No abstract available. Publisher's link: https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=55448 January 2019...
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Keywords:
Dina Gerdeman
- January 2021 (Revised October 2021)
- Case
eToro: Building the World's Largest Social Trading Network
By: Elie Ofek and Danielle Golan
Social trading platform eToro was preparing for the launch of its expanded offering in the U.S. The company faced critical decisions regarding product-market fit, go-to-market strategy, positioning and monetization. Moreover, it faced the challenge of how best to make...
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Keywords:
Social Trading Platform;
Investment;
Social and Collaborative Networks;
Marketing Strategy;
Expansion;
Digital Platforms
Ofek, Elie, and Danielle Golan. "eToro: Building the World's Largest Social Trading Network." Harvard Business School Case 521-057, January 2021. (Revised October 2021.)
- 30 Nov 2016
- Op-Ed
Where Could More Regulation Help Small Businesses? Online Lending.
paperwork, borrowers complete applications in minutes, with approval times cut to days, or even just a few minutes. And, in instances where borrowers want to shop and compare myriad options in one place, they can turn to marketplaces like...
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- 14 Nov 2017
- First Look
New Research and Ideas: November 14, 2017
process is strong regulatory oversight, which in the United States is provided by the U.S. Food and Drug Administration’s Center for Devices and Radiologic Health (FDA/CDRH). This viewpoint discusses the effect of the View Details
Keywords:
Carmen Nobel