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All HBS Web
(375)
- People (1)
- News (45)
- Research (243)
- Events (2)
- Multimedia (2)
- Faculty Publications (83)
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- January 2007 (Revised January 2007)
- Background Note
Note on the U.S. Food and Drug Administration
By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller
Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure.
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Keywords:
Health;
Governance Compliance;
Policy;
Product Development;
Government and Politics;
Pharmaceutical Industry;
Medical Devices and Supplies Industry;
Biotechnology Industry;
Public Administration Industry;
United States
Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)
- 05 Aug 2011
- Working Paper Summaries
An Exploration of Optimal Stabilization Policy
- 12 Jul 2004
- Research & Ideas
Michael Porter’s Prescription For the High Cost of Health Care
will need to be developed. In addition, people in small groups or with individual insurance policies face the likelihood that their premiums will rise sharply if someone in the family actually develops an expensive medical condition, even...
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- April 2010
- Teaching Note
Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug (Brief Case)
By: John A. Quelch and Heather Beckham
Teaching Note to 4183
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- 09 Feb 2024
- HBS Case
Slim Chance: Drugs Will Reshape the Weight Loss Industry, But Habit Change Might Be Elusive
what may at first blush appear to be an easier fix: new drugs such as Ozempic, Wegovy, and Mounjaro, says Harvard Business School Professor Regina E. Herzlinger, who has studied the American health care system for decades. Wegovy has been...
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- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
policy and regulatory policy innovation allowing us to do more with what we have,” she says. A quicker process could save millions—per drug The FDA didn’t receive additional...
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- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...
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Keywords:
Pharmaceuticals;
Drug Spending;
Drug Pricing;
Health Care and Treatment;
Spending;
Price;
Markets;
Cost Management;
United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
- 11 Sep 2019
- Research & Ideas
Germany May Have the Answer for Reducing Drug Prices
policies link price to value for important new therapies. “We’re looking at the extent to which these new German drug pricing laws were able to tie drugs’ negotiated prices to View Details
- 2021
- Working Paper
Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?
By: Eric Barrette, Leemore S. Dafny and Karen Shen
As of 2016 there were an estimated 2.1 million Americans suffering from opioid use disorder (OUD). To date, most policy interventions have focused on curbing opioid prescriptions and extending insurance coverage to include substance use disorder. However, relatively...
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Keywords:
Opioid Treatment;
Medication-assisted Treatment;
Substance Use Disorder;
Private Insurance;
Health Care and Treatment;
Health Disorders;
Insurance;
United States
Barrette, Eric, Leemore S. Dafny, and Karen Shen. "Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?" NBER Working Paper Series, No. 29001, July 2021.
- April 2017
- Supplement
Imprimis (B)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A). It describes the company’s decision to enter into the pharmaceutical compounding business in 2013–2014. Imprimis purchased a compounded ophthalmological medication called Dropless Therapy, which was injected into patients’...
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Keywords:
Healthcare;
Drug Compounding;
Drug Development;
Pharmaceuticals;
Small Business;
Decision-making, Business Model;
Mark Baum;
Imprimis;
Decision Making;
Strategy;
Health Care and Treatment;
Policy;
Pharmaceutical Industry;
United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (B)." Harvard Business School Supplement 717-496, April 2017.
- 19 Oct 2015
- Research & Ideas
Business Research that Makes for Smarter Public Policy
come up with quick policy advice, but to actually try to deepen understanding of those problems through rigorous academic research, which ultimately can lead to new remedies.” Outside of formal hearings, get-togethers between researchers...
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Keywords:
by Michael Blanding
- Research Summary
Clinical Trials as a setting for Health Policy and Management Research
The clinical trial marketplace is in flux. A decade ago, pharmaceutical firms almost exclusively conducted the study of their novel drug compounds within major academic medical centers. But today, industry-sponsored clinical trials are increasingly using community...
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- September 1998 (Revised June 1999)
- Case
Discovery Health (A)
A South African health insurance company undertakes a redesign of its prescription drug coverage policy in light of its experiences with Prozac.
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Keywords:
Motivation and Incentives;
Service Delivery;
Insurance;
Health Care and Treatment;
Insurance Industry;
South Africa
Chun, Samuel S., and Shaun Matisson. "Discovery Health (A)." Harvard Business School Case 599-046, September 1998. (Revised June 1999.)
- September 2014 (Revised February 2015)
- Case
Pfizer and AstraZeneca: Marketing an Acquisition (A)
By: John A. Quelch and James Weber
In 2014, Pfizer proposed a friendly acquisition of AstraZeneca, but the AstraZeneca board resisted over price and strategy concerns. Was this good for pharmaceutical consumers? Pfizer, like pharmaceutical companies in general, faced difficulties in growing sales due to...
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Keywords:
Health Care Policy;
Mergers And Acquisitions;
Marketing;
Government Relations;
Crisis Management;
Decision Making;
Growth and Development;
Management;
Markets;
Strategy;
Pharmaceutical Industry;
United Kingdom;
United States
Quelch, John A., and James Weber. "Pfizer and AstraZeneca: Marketing an Acquisition (A)." Harvard Business School Case 515-007, September 2014. (Revised February 2015.)
- Article
Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study
By: Maryaline Catillon
Keywords:
Biomedical Research;
R&D;
Innovation;
Technology;
Drug Trials;
RCT;
Health;
Healthcare;
Health Care And Treatment;
Health Care Policy;
Innovation and Invention;
Innovation Strategy;
Research and Development;
Technological Innovation;
Health Industry;
Pharmaceutical Industry
Catillon, Maryaline. "Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study." BMJ Open 9, no. 9 (September 2019).
- September 1998 (Revised July 1999)
- Case
Discovery Health (B)
By: Samuel S. Chun and Shaun Matisonn
A South African health insurance company grapples with designing a financially viable coverage solution for a new prescription drug treatment for male impotence.
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Keywords:
Motivation and Incentives;
Service Delivery;
Insurance;
Health Care and Treatment;
Insurance Industry;
South Africa
Chun, Samuel S., and Shaun Matisonn. "Discovery Health (B)." Harvard Business School Case 599-047, September 1998. (Revised July 1999.)
- January 2021
- Case
mPharma (A)
By: Rembrand Koning, John D. Macomber, Pippa Tubman Armerding and Wale Lawal
mPharma pioneered electronic prescriptions in Ghana, and aimed to increase drug affordability and accessibility in Africa, but the company remained unprofitable. Following investor concerns about mPharma's business, CEO Gregory Rockson considered alternative business...
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Keywords:
Strategy;
Entrepreneurship;
Acquisition;
Health;
Business Model;
Health Industry;
Technology Industry;
Ghana
Koning, Rembrand, John D. Macomber, Pippa Tubman Armerding, and Wale Lawal. "mPharma (A)." Harvard Business School Case 721-428, January 2021.
- October 2023
- Article
What Does the Inflation Reduction Act Mean for Patients and Physicians?
By: Amitabh Chandra and Benedic Ippolito
The debate around prescription drug measures in the recently passed U.S. Inflation Reduction Act (IRA), which limit some patients’ out-of-pocket costs, has not fully addressed their effect on physicians and patients via their effect on payers. Reducing patients’ costs...
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Chandra, Amitabh, and Benedic Ippolito. "What Does the Inflation Reduction Act Mean for Patients and Physicians?" NEJM Catalyst Innovations in Care Delivery 4, no. 10 (October 2023).
- Research Summary
Marketing and Competition in Pharmaceutical Markets
In his research on pharmaceutical markets, Professor King explores how marketing and product differentiation affect competition among firms in the prescription market for anti-ulcer drugs. Four main results emerge from an analysis of antiulcer drug sales from 1977 to...
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- January 2021
- Supplement
mPharma (B)
By: Rembrand Koning, John D. Macomber, Pippa Tubman Armerding and Wale Lawal
mPharma pioneered electronic prescriptions in Ghana, and aimed to increase drug affordability and accessibility in Africa, but the company remained unprofitable. Following investor concerns about mPharma's business, CEO Gregory Rockson considered alternative business...
View Details
Keywords:
Strategy;
Health;
Entrepreneurship;
Business Model;
Health Industry;
Technology Industry;
Ghana
Koning, Rembrand, John D. Macomber, Pippa Tubman Armerding, and Wale Lawal. "mPharma (B)." Harvard Business School Supplement 721-429, January 2021.