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  • 06 Feb 2007
  • First Look

First Look: February 6, 2007

2003, the firm has been waiting for the FDA to declare that meat and milk from cloned animals are no different from non-clones. During that period the company has worked to educate regulators, consumers, and members of the livestock chain... View Details
Keywords: Martha Lagace
  • 15 Jun 2016
  • Research & Ideas

These VC Partners May Make Your Firm Less Innovative

same VCs. Finally, they determined how “innovative” each company was, based on the number of new products they introduced that were approved by the FDA (averaging one product every two years). The data showed that companies tied to a... View Details
Keywords: by Michael Blanding; Financial Services; Banking
  • 29 Aug 2017
  • First Look

First Look at New Research and Ideas, August 29

loomed large. Purchase this case: https://cb.hbsp.harvard.edu/cbmp/product/215036-PDF-ENG Harvard Business School Case 910-403 GTC Biotherapeutics: Developing Medicines in the Milk of Goats GTC is the first company in the animal world to receive View Details
Keywords: Sean Silverthorne
  • 04 Apr 2019
  • Cold Call Podcast

Can Mark Zuckerberg Rebuild Trust in Facebook?

they're getting great results because of leadership. I think it's time for Mark Zuckerberg and Sheryl Sandberg to step up to leadership. Industries do not do a good job of self-regulation, so we have regulatory bodies. We don’t let pharma regulate itself. They have to... View Details
Keywords: Re: Daniel Rabetti
  • 15 Feb 2000
  • Research & Ideas

The Right Connections

connections can be a source of information about the FDA approval process and offer insights as to how to market and sell the young firm's products. They can also provide resources and contacts to facilitate these tasks. Another... View Details
Keywords: by Judith A. Ross
  • 06 Jun 2017
  • First Look

First Look at New Research and Ideas: June 6, 2017

Pharmacyclics is a biotechnology company that had received FDA approval in late 2013 for its flagship asset Imbrivica (ibrutinib), a biologic treatment for chronic lymphocytic leukemia and two other even rarer blood malignancies. Entering... View Details
Keywords: Sean Silverthorne
  • 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
  • 16 Apr 2001
  • Research & Ideas

Brand Power from Wedgwood to Dell: Part One

was a time of diluted, distorted foods. There was no FDA or FTC. His brand was created on quality, tastiness, pure manufacturing techniques, and on convenience. Convenience was not part of Wedgwood's equation. But convenience needed to be... View Details
Keywords: by Martha Lagace
  • 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
  • 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
  • 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... View Details
Keywords: Martha Lagace
  • 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
  • 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
  • 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
  • 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
  • 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
  • 10 Oct 2017
  • First Look

First Look at New Research and Ideas, October 10, 2017

https://www.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... View Details
Keywords: Sean Silverthorne

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