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- February 2025
- Case
Abiomed: A Change of Heart
By: Satish Tadikonda, Faith Robertson and William Marks
After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details
- February 2025
- Case
Abiomed: Clinical Trials and Tribulations
By: Satish Tadikonda, Faith Robertson and William Marks
After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial... View Details
- June 2023 (Revised July 2024)
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
- 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... View Details
- 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
- 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... View Details
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
- 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... View Details
- 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... View Details
- Fall 2020
- Article
Christo and Jeanne‐Claude: The Negotiation of Art and Vice Versa
Over the past two decades the Program on Negotiation at Harvard Law School (PON) has named thirteen people as Great Negotiators. The project, directed by my colleague Jim Sebenius, has given us the opportunity to commend our honorees’ outstanding work and to learn from... View Details
- 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’... View Details
- November 2019
- Teaching Note
Actera Group: Investing in Mars Cinema Group (A) and (B)
By: Victoria Ivashina and Jeffrey Boyar
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,... View Details
- September 2017
- Supplement
Actera Group: Investing in Mars Cinema Group (A)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,... View Details
- September 2017
- Supplement
Actera Group: Investing in Mars Cinema Group (B)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second larger player in the market, AFM,... View Details
- September 2017 (Revised July 2019)
- Case
Actera Group: Investing in Mars Cinema Group (A)
By: Victoria Ivashina and Eren Kuzucu
In summer of 2010, Murat Çavuşoğlu (HBS MBA 1994) led private equity firm Actera Group’s investment in Mars Cinema Group (Mars), the leading movie exhibitor in Turkey. Immediately after acquiring Mars and merging it with the second largest player in the market, AFM,... View Details
- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
- 5 Feb 2013
- Conference Presentation
Financing Entrepreneurial Growth
By: Tom Alberg, Andrew A. Bogan, Harold Bradley, Robert D. Cooter, Monika Gruter Cheney, Oliver R. Goodenough, William R. Hambrecht, Frank Hatheway, Thomas F. Hellmann, Marianne Hudson, Jared Konczal, Josh Lerner, Robert E. Litan, Diane Mulcahy, Ramana Nanda, Frank Partnoy, Joe Ratterman, Nava Ravikant, Jay R. Ritter, Alicia Robb, David T. Robinson, Allison Schrager, Barry Silbert, E. R. Sirri, Daniel Stangler and Sharon Vosmek
Despite recent innovations in entrepreneurial finance, particularly at the early stage of business creation, many new and young companies continue to face hurdles to acquire capital.
The Kauffman Foundation addressed current challenges and opportunities in... View Details
- 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
- 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... View Details
- 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... View Details