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      • June 2023
      • 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 case...  View Details
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      Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023.
      • 2023
      • Working Paper

      Evaluation and Learning in R&D Investment

      By: Alexander P. Frankel, Joshua L. Krieger, Danielle Li and Dimitris Papanikolaou
      We examine the role of spillover learning in shaping the value of exploratory versus incremental R&D. Using data from drug development, we show that novel drug candidates generate more knowledge spillovers than incremental ones. Despite being less likely to reach...  View Details
      Keywords: Research and Development; Forecasting and Prediction; Valuation; Pharmaceutical Industry
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      Frankel, Alexander P., Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou. "Evaluation and Learning in R&D Investment." Harvard Business School Working Paper, No. 23-074, May 2023. (NBER Working Paper Series, No. 31290, May 2023.)
      • May 2023 (Revised June 2023)
      • Case

      Novartis (A): Reimagining Medicine

      By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
      This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...  View Details
      Keywords: Health Care and Treatment; Business Model; Leadership; Pharmaceutical Industry; Switzerland
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      Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (A): Reimagining Medicine." Harvard Business School Case 723-443, May 2023. (Revised June 2023.)
      • May 2023 (Revised June 2023)
      • Supplement

      Novartis (B): Reimagining Medicine

      By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
      This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...  View Details
      Keywords: Health Care and Treatment; Business Model; Production; Business Strategy; Pharmaceutical Industry
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      Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (B): Reimagining Medicine." Harvard Business School Supplement 723-444, May 2023. (Revised June 2023.)
      • May 2023 (Revised June 2023)
      • Supplement

      Novartis (C): Reimagining Medicine

      By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
      This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...  View Details
      Keywords: Health Testing and Trials; Health Care and Treatment; Business Model; Problems and Challenges; Pharmaceutical Industry; Switzerland
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      Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)
      • April 2023
      • Background Note

      Note on Healthcare in Ghana

      By: Regina E. Herzlinger and Ben Creo
      This note accompanies case 323-033, “mPharma: Scaling Access to Affordable Primary Care in Africa” which discusses mPharma’s make-or-break strategic decisions. This note’s coverage of the Ghanaian healthcare system ranges from how care and drugs are delivered and...  View Details
      Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Health Industry; Pharmaceutical Industry; Ghana
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      Herzlinger, Regina E., and Ben Creo. "Note on Healthcare in Ghana." Harvard Business School Background Note 323-112, April 2023.
      • February 2023
      • Teaching Note

      Cost Plus Drugs

      By: Alexander J. MacKay
      Teaching Note for HBS Case No. 723-362.  View Details
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      MacKay, Alexander J. "Cost Plus Drugs." Harvard Business School Teaching Note 723-037, February 2023.
      • 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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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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.
      • January 2023
      • Teaching Note

      The Opioid Settlement and Executive Pay at AmerisourceBergen

      By: Suraj Srinivasan and Li-Kuan Ni
      Teaching Note for HBS Case No 122-014. In 2020, AmerisourceBergen Corporation, a Fortune 50 company in the drug distribution industry, agreed to settle thousands of lawsuits filed nationwide against the company for its opioid distribution practices that critics alleged...  View Details
      Keywords: Opioids; Shareholder Activism; Investment Activism; Corporate Accountability; Corporate Governance; Governance Compliance; Governance Controls; Executive Compensation; Risk Management; Corporate Social Responsibility and Impact; Business and Shareholder Relations; Business and Stakeholder Relations; Distribution Industry; Health Industry; Pharmaceutical Industry; United States; West Virginia; Tennessee; Ohio; Pennsylvania
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      Srinivasan, Suraj, and Li-Kuan Ni. "The Opioid Settlement and Executive Pay at AmerisourceBergen." Harvard Business School Teaching Note 123-067, January 2023.
      • January 2023
      • Case

      Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery

      By: Regina Herzlinger and Brian Walker
      What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful...  View Details
      Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
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      Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
      • 2022
      • Working Paper

      Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

      By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
      Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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      Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
      • November 2022
      • Case

      The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales

      By: Regina E. Herzlinger and Tiffany Farrell
      Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous...  View Details
      Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
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      Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
      • November 2022 (Revised February 2023)
      • Case

      Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams

      By: Debora L. Spar and Julia M. Comeau
      In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication...  View Details
      Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Pharmaceutical Industry; Medical Devices and Supplies Industry; United States; District of Columbia
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      Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised February 2023.)
      • October 2022
      • Case

      Cost Plus Drugs

      By: Alexander MacKay and James Barnett
      In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....  View Details
      Keywords: Business Ventures; Decision Making; Entrepreneurship; Ethics; Health; Markets; Social Enterprise; Society; Strategy; Health Care and Treatment; Business Divisions; Factories, Labs, and Plants; Health Industry; Pharmaceutical Industry; United States; Texas
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      MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
      • September 2022
      • Article

      Find and Replace: R&D Investment Following the Erosion of Existing Products

      By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor
      How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first...  View Details
      Keywords: R&D Investments; Drug Development; Product Shocks; M&A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry
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      Krieger, Joshua L., Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Management Science 68, no. 9 (September 2022): 6552–6571.
      • September 2022
      • Article

      Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities

      By: Leemore Dafny, Christopher Ody and Teresa Rokos
      The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...  View Details
      Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
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      Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
      • September 2022
      • Article

      The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente

      By: Alyce S. Adams, Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong and Wesley Yin
      Most hospitals have financial assistance programs for low-income patients. We use administrative data from Kaiser Permanente to study the effects of financial assistance on health care utilization. Using a regression discontinuity design based on an income threshold...  View Details
      Keywords: Healthcare; Utilization; Financial Assistance; Health Care and Treatment; Social Issues; Poverty; Health Industry
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      Adams, Alyce S., Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong, and Wesley Yin. "The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente." American Economic Review: Insights 4, no. 3 (September 2022): 389–407.
      • 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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      Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
      • 2022
      • Working Paper

      Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

      By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
      Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...  View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
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      Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
      • April 18, 2022
      • Article

      Will mRNA Technology Companies Spawn Innovation Ecosystems?

      By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern
      The mRNA technologies that helped rapidly create effective COVID-19 vaccines could become technology platform businesses, which has tremendous implications for players in the world of drug development. These platforms could attract other companies interested in...  View Details
      Keywords: Health Care; Digital Health; Technology; Innovation; Health Care and Treatment; Technological Innovation; Digital Transformation; Health Industry; United States
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      Grimpe, Christoph, Timo Minssen, W. Nicholson Price, II, and Ariel Dora Stern. "Will mRNA Technology Companies Spawn Innovation Ecosystems?" Harvard Business Review (website) (April 18, 2022).
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