Filter Results:
(166)
Show Results For
- All HBS Web (166)
- Faculty Publications (66)
Show Results For
- All HBS Web (166)
- Faculty Publications (66)
- 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... View Details
Keywords: Sean Silverthorne
- 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:... View Details
Keywords: 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,... View Details
Keywords: Julia Hanna
- 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... View Details
Keywords: 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... View Details
Keywords: by Paul Michelman
- 16 Jul 2019
- News
The Making of a Movement
today,” David observes. “Earlier this year, for example, the FDA approved a new treatment that resulted from research that Cycle for Survival donations helped fund. That was Jen’s dream. That was the goal that guided every decision we... View Details
- 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... View Details
Keywords: by Henry Chesbrough
- 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... View Details
Keywords: 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... View Details
Keywords: 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... View Details
- 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... View Details
Keywords: by Sean Silverthorne
- 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... View Details
Keywords: Sean Silverthorne
- 01 Dec 2013
- News
Curing Health Care
fundraising, IP, patent law, and the ins and outs of FDA and HIPAA regulations. Tecco and Gross refined their vision for Rock Health in a field study with HBS senior lecturer Bob Higgins. But first, Tecco had the experience of founding... View Details
- 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... View Details
Keywords: 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... View Details
Keywords: Martha Lagace
- 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... View Details
- Web
Faculty & Advisors | MBA
Previously, Prem served as a Product Lead on Google Search’s Social Impact verticals including launching Health Search and helping create the first FDA approved deep learning, medical screening algorithm. He also launched the Internet Bus... View Details
- 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... View Details
Keywords: Sean Silverthorne
- 05 Mar 2019
- First Look
New Research and Ideas, March 5, 2019
to minors—an allegation JUUL Labs’s executives strongly denied. The company now faced an FDA probe and investigations by at least two state attorney generals. It needed a strategy to deal with its mounting regulatory and public relations... View Details
Keywords: Dina Gerdeman
- 12 Jul 2021
- News
Alumni Confront the COVID-19 Crisis
“We have a highly effective mask that protects both the health professionals and the patients from transfer of microorganisms, body fluids, and particulate matter,” says Sarka, who is submitting the product for an Emergency Use Authorization and View Details