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- All HBS Web (169)
- Faculty Publications (64)
Donald H. Rumsfeld
profit of over $120 million in 1982. The real success of Searle under Rumsfeld, however, came with the FDA approval of Aspartame, the artificial sweetener that became popular and very profitable for Searle during the 1980s diet craze.
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Healthcare
- 09 Apr 2019
- News
Finding a Fix for Food Allergies
photo by Stu Rosner Food allergies affect 30 million Americans and one in 12 children, sometimes triggering life-threatening reactions. Yet there are no approved FDA treatments or cures. These sobering facts became alarmingly real to...
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Jill Radsken
- Fast Answer
Medical Devices: Pipeline
agencies, and private industry. Studies listed in the database are conducted in 50 states and 157 countries. US FDA Medical Device Databases – provides a list of over 20 specific databases covering guidance, pre-market approval,...
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- 14 Dec 2020
- Research & Ideas
What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?
aspects of the drug trial and approval process, including allowing time for potential issues to materialize. When you see an FDA emergency approval for a COVID-19 vaccine, don't interpret this as a normal “FDA approval.” I understand that...
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- 24 Apr 2014
- News
Fighting the diabetes epidemic using mobile phones
scientists, and clinicians work together,” says Jena, whose product is now being piloted at three major hospital centers across India. He expects US FDA approval for their product by November 2014. (Published April 2014)
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Biotech, Medical devices, and Pharmaceuticals: regulatory information
Tip: may use the search function to have a jump start. Nexis Uni – IP cases, case law, government document. FDA Regulatory Information portal Emergo -- Web site of regulatory consulting firm provides...
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- 01 Mar 2011
- News
Fixing What Ails the Drug Industry
In 2008, private investors and the National Institutes of Health plowed more than $100 billion into pharmaceutical research. And yet, “We’re not seeing the new diagnostics, treatments, preventative approaches, and cures that we might have expected,” View Details
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Pharmaceuticals: Pipeline
Profiles cover detailed information such as alternative names, therapeutic uses, FDA actions and licensing changes, companies associated with development of the drug, etc. To begin a search, use the function BI PHRM DEX, select...
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- 01 Jun 2012
- News
The Power of Philanthropy
Boston Globe (February 9, 2012). “Joe could have turned away and said he hates this disease, but he didn’t,” said C. Richard Mattingly, COO of the Cystic Fibrosis Foundation. “He led us. He wasn’t working to save Joey’s life. He was working for others who still had a...
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- 01 Dec 2017
- News
2017 in Health Care: Telemedicine Has Arrived
drug and the FDA says it is safe and effective and doctors prescribe it, insurance generally will pay for it. But everyone is getting fed up with that approach—the ‘Pharma bro’ Martin Shkreli did not help—and we’ve reached a critical mass...
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- 01 Sep 2008
- News
Mara Aspinall
accordingly. In several areas of oncology, particularly blood cancers, we have also moved close to full acceptance. Is there a role for the FDA to play in bringing personalized medicine more into the mainstream? The View Details
- 31 Oct 2004
- Research & Ideas
Bypass Marketing: Are Docs Influenced?
directly to consumers as we have come to know it was first advocated by the pharmaceutical industry in 1981. In 1983, the FDA requested a voluntary moratorium on such advertising in order to study its likely effects. The View Details
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by Manda Salls
- 01 Sep 2015
- Blog Post
Building a Startup at HBS
next steps are to ensure we have all the necessary FDA approvals, to get more of our product units into the hands of doctors and nurses in hospitals, and to begin the sales process with the hospitals from which we originally received...
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- 01 Mar 2007
- News
Daniel Vasella
(twenty years in the United States), and the other is the solidity of the patent. Regarding length, it’s a sensitive point. If we have delays in FDA regulatory approval because more questions are being asked, or if we are more diligent...
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- 01 Jun 2000
- News
The Right Connections
impact on the size of the start-up's IPO. "Downstream social capital was essential in attracting the interest of a top investment bank and getting a high valuation for the IPO," Higgins says. Such downstream connections can be valuable sources of information about the...
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Judith A. Ross
- 01 Mar 2016
- News
Off Script
because the present ratio in pharma R&D spend is in the high teens. The best way to improve the cost of prescription drugs is to improve the supply of new drugs. The two best approaches to this are modernizing the FDA so it gets a “pro-...
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- 01 Sep 2016
- News
Pricing Paradise
eliminated; a 20 percent loss due to budget cuts was deemed a realistic possibility.) The researchers adopted the “willingness-to-pay” methodology that federal agencies such as OSHA and the FDA use to determine how much people would pay...
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Julia Hanna
- 13 Nov 2020
- News
Student Startups Help Fight COVID-19
Labs. “A crisis like this illuminates the importance of innovation.” One example is Umbulizer, which offers a reliable, portable ventilator at 10 percent of the cost of a $40,000 hospital-grade machine. The device recently gained emergency View Details
- 04 Sep 2019
- News
Accelerating Scientific Discovery
have, and how can we support their development?” Chandra explains that because “science is long and hard”—running the gamut from basic research and drug discovery, to clinical trials, to FDA review and approval, to post-approval...
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Jennifer Gillespie
- 01 Dec 2013
- News
Your Own Medicine
spur further developments. John Crowley's (MBA 1997) quest to conquer Pompe disease began when his son and daughter were diagnosed with the rare, often fatal neuromuscular disorder in 1998. He helped push the development of the first-ever treatment for Pompe, approved...
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