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- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details
- August 2012 (Revised December 2023)
- Background Note
Note on Health Insurance Coverage, Coding, and Payment
By: Regina E. Herzlinger and Jo Ellen Slurzberg
This note explains how health care technology and service innovators receive payment from government insurers, in the U.S. and abroad, and from private insurers. It describes each of the three steps needed to obtain reimbursement: coverage, coding, and payment. It also... View Details
- October 2010 (Revised November 2010)
- Background Note
Plavix: Drugs in the Age of Personalized Medicine
By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon
PIavix, one of the world's best selling drugs in 2010, appears to have a limited future. Its patent was due to expire soon, and recently new data had been discovered that indicated that a small subset of the population would be at risk for stroke, heart attack, or even... View Details
- July 2010
- Case
Metabical: Positioning and Communications Strategy for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Cambridge Sciences Pharmaceuticals (CSP) expects final approval for its revolutionary weight loss drug, Metabical. Metabical will be the only weight loss drug with FDA approval that is also clinically proven to be effective for moderately overweight people. Barbara... View Details
- April 2010
- Case
Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Metabical is a new weight loss drug from Cambridge Sciences Pharmaceuticals intended for moderately overweight individuals. In anticipation of final FDA approval, the senior director of marketing, Barbara Printup, prepares for the product launch and must make several... View Details
- November 2009 (Revised August 2010)
- Case
NovoCure Ltd.
By: William A. Sahlman and Sarah Flaherty
Venture capitalist William Doyle must raise $35 million for a portfolio company with a promising, novel cancer therapy, just as global capital markets are imploding in the fall of 2008. NovoCure, Ltd., has developed an electrical-field-based therapy, called Tumor... View Details
- November 2009 (Revised December 2009)
- Case
GTC Biotherapeutics: Developing Medicines in the Milk of Goats
By: Ray A. Goldberg and Sarah Morton
GTC is the first company in the animal world to receive FDA approval of a transgenic pharmaceutical. What are the implications for other firms in plants and animals and their opportunities to produce new medicines in an economical and safe fashion? View Details
- 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
- March 2008
- Case
The Multiple Sclerosis Center of Atlanta
By: Regina E. Herzlinger and Alfred Martin
The Multiple Sclerosis Center of Atlanta wishes to expand beyond Georgia. The factors influencing this decision are discussed, including drug treatments currently available, and the impact of future drugs in the FDA pipeline as well as financing issues. View Details
- November 2007
- Case
Antegren: A Beacon of Hope
By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann
The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion... View Details
- 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. View Details
- December 2006 (Revised January 2008)
- Case
ViaGen: Revolutionizing the Livestock Industry
By: David E. Bell, Reed Martin and Mary L. Shelman
ViaGen has invested heavily to develop cloning technology for the livestock industry. Cloning has the potential to significantly improve the genetics of livestock, leading to higher quality meat, healthier animals, and more efficient production. Since 2003, the firm... View Details
- November 2006 (Revised May 2025)
- Case
Eli Lilly: Developing Cymbalta
By: Elie Ofek and Ron Laufer
Anticipating the expiration of its Prozac patent, Eli Lilly has to make tough decisions regarding the development of its next-generation antidepressant drug. In particular, the company needs to decide whether to first establish that once-a-day dosing for Cymbalta... View Details
- August 2001
- Case
Scios, Inc.
Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process. View Details
- July 2001 (Revised August 2005)
- Case
Medicines Company, The
It is early 2001 and the Medicines Co. just received FDA approval to market Angiomax, a blood thinner to be used during angioplasties and heart procedures. It is intended to be a better alternative to Heparin, an 80-year-old drug that costs less then $10 per dose. The... View Details
- January 2001 (Revised July 2003)
- Case
Pharmacyclics: Financing Research & Development
By: Malcolm P. Baker, Richard S. Ruback and Aldo Sesia
Pharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more... View Details
- April 1998
- Case
Cephalon, Inc.
By: Peter Tufano
In early 1997, Cephalon, awaited an FDA panel's decision on whether its drug, Myotrophin, would be approved. If the drug was approved, the firm might need substantial additional funds to commercialize as well as to buy back rights to it (which had been sold earlier to... View Details
- February 1992 (Revised September 2003)
- Case
Beech-Nut Nutrition Corporation (A-1)
By: Lynn S. Paine
The CEO of Beech-Nut Nutrition Corp. must decide what to do when he receives information that the company's supply of apple juice concentrate may be adulterated. The concentrate is used in many of the company's juice products. It appears that others in the company may... View Details
- November 1991
- Case
Monsanto's March into Biotechnology (B)
Monsanto has yet to receive FDA approval for BST, a growth hormone for cows. Anti-BST groups have successfully lobbied Wisconsin and Minnesota, major milk producing states, to ban milk from BST-injected cows; the FDA has charged Monsanto with improperly promoting BST... View Details