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SSRN

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October 2012 (Revised December 2013)
Case

Urbanizing China

By: Lakshmi Iyer and G.A. Donovan

In 2012, China attained a historic development milestone with more Chinese citizens living in cities than in the countryside. China's rapid urbanization, and the accompanying conversion of agricultural land to non-agricultural uses, raised a number of economic, social,... View Details

Keywords: China; Urbanization; Industrialization; Property Rights; Local Government Finance; Social Protest; Business Environment; Food Security; Safety; Change Management; Food; Urban Development; Social Issues; Growth and Development Strategy; Public Administration Industry; Public Administration Industry; China

August 2008 (Revised September 2008)
Case

The Flaxil Label (B)

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Governance; Risk and Uncertainty; Value Creation; Negotiation; Attitudes; Health Care and Treatment; Government Administration; Pharmaceutical Industry; United States

August 2008 (Revised September 2008)
Case

The Flaxil Label (A)

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Product Launch; Negotiation Process; Business and Government Relations; Safety; Pharmaceutical Industry

September 2013 (Revised August 2015)
Background Note

Leadership and Teaming

By: Ethan Bernstein

Small differences in the leadership of teams can have large consequences for the success of their efforts. Many initiatives fail not because of a fatal error in judgment or insufficient ideas, knowledge, motivation, or capabilities to deliver a solution. They fail... View Details

22 Jun 2021
Research & Ideas

The COVID-19 Mutiny: When Teams Leave and Take Their Clients

industrial washer in the spin cycle, putting entire industries (arts and entertainment, tourism, food and hospitality) at risk even as others (real estate, construction, View Details

Keywords: by Robin Abrahams, Boris Groysberg, and Steven L. Manchel

05 Jun 2018
First Look

New Research and Ideas, June 5, 2018

Mondelēz International Mondelēz International is a packaged foods company competing primarily in “snacks” around the globe. The case describes how and why the Kraft Inc. CEO, View Details

Keywords: Dina Gerdeman

January 2014 (Revised June 2014)
Case

23andMe: Genetic Testing for Consumers (A)

By: John A. Quelch and Margaret L. Rodriguez

On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details

Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States

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

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2024
Working Paper

Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions

By: Caleb Kwon, Ananth Raman and Jorge Tamayo

We investigate whether corporate officers should grant managers discretion to override AI-driven demand forecasts and labor scheduling tools. Analyzing five years of administrative data from a large grocery retailer using such an AI tool, encompassing over 500 stores,... View Details

Keywords: AI and Machine Learning; Forecasting and Prediction; Working Conditions; Performance Productivity

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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

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

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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... View Details

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... View Details

Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States

November 2020
Teaching Note

Valuing Celgene's CVR

By: Benjamin C. Esty and Daniel Fisher

Teaching Note for HBS Case No. 221-031. 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)... View Details

Keywords: Mergers and Acquisitions; Valuation; Value; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States

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... View Details

Keywords: by Sean Silverthorne

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. View Details

Keywords: Strategy; Knowledge Use and Leverage; Sales; Pharmaceutical Industry