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- All HBS Web (171)
- Faculty Publications (65)
- 08 Jan 2008
- First Look
First Look: January 8, 2008
challenges arise against the backdrop of the accelerated approval process, uncertainty about what the FDA will ultimately decide, and whether the company should indeed pursue early approval. Purchase this case:...
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Martha Lagace
- 01 Jun 2000
- News
The Business of Biotech
combination of professional and personal factors," Williams says, adding that he left his job at a technology consulting firm and joined a biotech start-up soon after that conversation. Time - a precious asset in any industry - has special value in biotech,...
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Julia Hanna
- 06 Dec 2021
- News
Vision: Sound Science
It was a milestone to celebrate: Earlier this year, designations from FDA and European Union regulators moved researchers at the Boston-based startup Akouos, Inc., a step closer to producing the first-ever therapy for gene-mediated...
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Deb Blagg
- 31 Jul 2007
- First Look
First Look: July 31, 2007
would mean navigating the FDA approval process, as well as raising the capital necessary to finance the endeavor. It was up to Bollinger to decide on a strategy for Vascugel's clinical trials. In addition, he would have to decide how much...
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Martha Lagace
- 07 Apr 2003
- Research & Ideas
XTV: Xerox’s Attempted Recovery From “Fumbling the Future”
with researchers at PARC. Much of that time was occupied with interviewing prospective customers who had significant problems with document management. For example, a pharmaceutical company that was applying for FDA approval had to manage...
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by Henry Chesbrough
- 07 Aug 2000
- Research & Ideas
The Business of Biotech
are fundamental to biotech's success.—Gail Maderis Time—a precious asset in any industry—has special value in biotech, particularly since the multiphase FDA approval process can add years to a drug's development. "My biggest source...
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- 01 Dec 2019
- News
The Race Against Resistance
people die as a result. And yet, there are only 42 antibiotics currently in clinical development, and typically only 20 percent of infectious disease drugs that enter phase 1 clinical trials will receive FDA approval. Eric Kimble (MBA...
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Lisa Scanlon Mogolov
- 14 Aug 2018
- First Look
First Look at New Research and Ideas, August 14, 2018
in partnering with Spark to develop its hemophilia B program. Also, the company is working with the FDA on a potential change to its protocol. The CEO is preparing for a board meeting, and he is contemplating the best path to deal with...
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by Sean Silverthorne
- 09 Feb 2010
- First Look
First Look: Feb. 9
human patients. Doyle believes NovoCure has the potential to become an important company with a major new cancer therapy platform but must complete pivotal (Phase III) clinical trials and receive FDA approval. Doyle's venture capital...
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Martha Lagace
- 22 Aug 2005
- Research & Ideas
Balancing the Future Against Today’s Needs
remote monitoring service for cardiac device patients, which hit the market well before 2010 (the FDA approved it in January 2002). It was only by thinking in terms of "reinvention," says George, that this could have been...
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by Paul Michelman
- 15 Apr 2014
- First Look
First Look: April 15
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 marketed as a diagnostic and preventative tool and that it was subject to...
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Sean Silverthorne
- 10 Oct 2017
- First Look
First Look at New Research and Ideas, October 10, 2017
https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=53307 Harvard Business School Case 518-031 MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work In June 2014, MannKind Corporation announced that after years of development and billions of dollars in...
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Sean Silverthorne
- 01 Mar 2010
- News
Sole Mates
FDA to work 1 million acres of forest, a concession worth hundreds of millions of dollars. Every word of the company’s forty-page proposal was plagiarized from a U.S. Forest Service report on woodlands 7,000 miles away. And even though I...
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- 05 Feb 2013
- First Look
First Look: Feb. 5
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...
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Sean Silverthorne
- 18 Dec 2018
- First Look
New Research and Ideas, December 18, 2018
R&D-intensive firms react to negative shocks to their existing products? We explore this question using detailed project-level data from drug development firms. Using FDA Public Health Advisories as an exogenous and idiosyncratic...
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Dina Gerdeman
- 19 Sep 2017
- First Look
First Look at New Research and Ideas, September 19
time, Imprimis was in the process of seeking FDA approval for a branded drug called Impracor. This process, already difficult, was further complicated by recent manufacturing issues. Meanwhile, the opportunity arose for Imprimis to...
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Sean Silverthorne
- 13 Feb 2018
- First Look
New Research and Ideas, February 13, 2018
improve the care of patients with diabetes by contracting an app. They go through a rigorous evaluation of the FDA regulations, the existing market, and potential commercial competitors to try and identify a market opportunity. Since...
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Sean Silverthorne
- 07 Aug 2007
- First Look
First Look: August 7, 2007
and issues around current practices. Purchase this note: http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807124 U.S. Food and Drug Administration Harvard Business School Note 807-050 Describes the U.S. FDA with particular...
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Martha Lagace
- 07 Dec 2010
- First Look
First Look: Dec. 7
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 death if they took PIavix. As a result, the FDA had added a black box warning—the...
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Sean Silverthorne
- 01 Dec 1996
- News
An Entrepreneurial Journey
habit. Introduced as a prescription drug in 1992 by de Weese's company, California-based Cygnus Research Corporation (now Cygnus, Inc.), Nicotrol represented a breakthrough in transdermal patch technology. Receiving FDA approval in a...
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