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All HBS Web
(485)
- People (1)
- News (143)
- Research (266)
- Events (1)
- Multimedia (3)
- Faculty Publications (92)
- 01 Apr 2014
- News
FDA Moves to Regulate E-Cigarettes
- November 2020
- Case
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...
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Keywords:
Mergers and Acquisitions;
Value;
Valuation;
Judgments;
Decision Making;
Cash Flow;
Financial Instruments;
Cognition and Thinking;
Pharmaceutical Industry;
Biotechnology Industry;
United States
Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Case 221-031, November 2020.
- 25 Sep 2018
- First Look
New Research and Ideas, September 25, 2018
operations. Product failures are, therefore, likely to impact firms’ subsequent innovation activities. Using 13 years of Food and Drug View Details
Keywords:
Dina Gerdeman
- 01 Dec 2022
- News
December 2022 Alumni and Faculty Books and Podcasts
Westminster, Bingham juggled vaccine suppliers, Whitehall, the media circus—and her daughter’s exams. Political maneuvering, miscommunications, and administrative meddling nearly jeopardized the project, but...
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- 19 Dec 2017
- First Look
New Research and Ideas, December 19, 2017
Abstract—No abstract available. Publisher's link: https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=53633 Characterizing the Drug Development Pipeline for Precision Medicines By: Chandra, Amitabh, Craig Garthwaite, View Details
Keywords:
Carmen Nobel
- November 2010
- Supplement
Hikma Pharmaceuticals (B)
By: John A. Quelch
By 2009, Hikma Pharmaceuticals operated 13 manufacturing plants in 8 countries of which 5 were approved by the U.S. Food and Drug Administration. Hikma tracked its sales revenues over the period to show where the largest contributors were from.
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Quelch, John A. "Hikma Pharmaceuticals (B)." Harvard Business School Supplement 511-075, November 2010.
- 01 Dec 2015
- News
Leading Boston and Beyond
(MBA 2002), served as the city’s CFO from 2010 to 2014 after working as an advisor to the mayor and serving in the department of administration and finance. Mitch Weiss (MBA...
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- 31 Oct 2017
- First Look
New Research and Ideas, October 31, 2017
developed new product categories such as organic food and wind and solar energy, which explicitly focused on sustainability. Again this process has been traced back to the...
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by Sean Silverthorne
- November 2020
- Supplement
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...
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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 24 Sep 2007
- Research & Ideas
The FDA: What Will the Next 100 Years Bring?
The U.S. Food and Drug Administration, which was created by the passage of the 1906 Federal Food and View Details
- October 2020 (Revised November 2023)
- Case
COVID-19 Testing at Everlywell
By: Jeffrey J. Bussgang and Olivia Hull
In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the...
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Keywords:
Entrepreneurship;
Business Strategy;
Venture Capital;
Health Care and Treatment;
Health Disorders;
Leading Change;
Technology Adoption;
Digital Platforms;
Competitive Strategy;
Science;
Adaptation;
Corporate Social Responsibility and Impact;
Crisis Management;
Social Entrepreneurship;
Ethics;
Government Legislation;
Health;
Health Testing and Trials;
Health Pandemics;
Consumer Products Industry;
Health Industry;
Technology Industry;
Texas;
United States
Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020. (Revised November 2023.)
- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,...
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Keywords:
Safety;
Industry Growth;
Marketing;
Research and Development;
Health Testing and Trials;
Economics;
Pharmaceutical Industry;
United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- 05 Dec 2017
- First Look
First Look at New Research and Ideas, December 5, 2017
sales, marketing, and communication had made its yogurt a hit with consumers, and its entrepreneurial and innovative culture made it popular with its employees. But by 2012,...
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Keywords:
Sean Silverthorne
- 23 Jun 2015
- Video
Innovations Wanted: Beating Brain Disease
- 08 Dec 2022
- HBS Case
The War in Ukraine and Nestlé’s Moral Dilemma: Stay or Leave Russia?
Nestlé, the world’s largest food and beverage company, faced a difficult choice last February as Russian tanks rolled across Ukraine, and the 24/7 news View Details
- November 2017
- Case
The 'Wonder Drug' That Killed Babies
By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children...
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Keywords:
Regulation;
Business and Government Relations;
Business and Community Relations;
Business and Stakeholder Relations;
Product Marketing;
Corporate Social Responsibility and Impact;
Business History;
Health;
Government Legislation;
Corporate Accountability;
Ethics;
Governing Rules, Regulations, and Reforms;
Public Administration Industry;
Public Administration Industry;
United States;
United Kingdom;
Australia;
Germany;
Europe
Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
- 10 Jan 2024
- Research & Ideas
Technology and COVID Upended Tipping Norms. Will Consumers Keep Paying?
brought along by the pandemic have ushered in changes to the informal customs around who gets tips and how much, according to Jill Avery, senior lecturer of business administration View Details
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by Anna Lamb, Harvard Gazette
- 20 Dec 2018
- Research & Ideas
Most Popular Stories and Research Papers of 2018
Cirrus Foroughi, and Barbara Larson. Developing Novel Drugs This paper by Joshua Krieger and colleagues contributes to our understanding of how financing constraints affect the...
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Keywords:
by Sean Silverthorne