ORDER NOW & RECEIVE 30% OFF: Nudging Health:

Johns Hopkins University Press, October 2016
by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), and Christopher T. Robertson (Academic Fellow alumnus), eds.

Abstract of the Introduction: 

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This introductory chapter to the edited volume Nudging Health:...

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Trump’s HHS Pick Favored Drugmakers, Device Makers And Doctors

Kaiser Health News, January 23, 2017
by Christina Jewett and Marisa Taylor

As Cabinet nominee Tom Price faces a Senate confirmation hearing Tuesday, a newly released trove of...

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When clinical trials compete: prioritising study recruitment

Journal of Medical Ethics, January 20, 2017 (online)
by Luke Gelinas (Clinical Research Ethics Fellow), Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, and I. Glenn Cohen (Faculty Director)

Abstrac

t

It is not uncommon for multiple clinical trials at the same institution to recruit concurr...

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Crucial California HIV Program In Disarray After Contract Switch

Kaiser Health News, January 19, 2017
by Anna Gorman

A change in contractors for a state-run AIDS program has resulted in enrollment delays and left some...

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6 Senators Assessing Trump’s HHS Nominee Own Health Care Stocks, Too

NPR, January 18, 2017
by Sydney Lupkin

President-elect Donald Trump's pick to run the Department of Health and Human Services is taking...

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Donors and Drug Makers Offer $500 Million to Control Global Epidemics

New York Times, January 18, 2017
by Donald G. McNeil, Jr.

Stung by the lack of vaccines to fight the West African Ebola epidemic, a group of prominent donors...

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Mid-Atlantic Health Law Works-in-Progress Retreat
Seton Hall Law School

Deadline: February 03, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to...

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Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

>Abstract: Inventors face a stark choice between two intellectual property systems of protecting... Read More

From Twitter To Treatment Guidelines, Industry Influence Permeates Medicine

NPR, January 17, 2017
by Charles Ornstein

The long arm of the pharmaceutical industry continues to pervade practically every area of medicine,...

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Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies

Kaiser Health News, January 17, 2017
by Sarah Jane Tribble and Sydney Lupkin

More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at mot...

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Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-148
0
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUI
T  
; AMGEN INC., AMGEN MANUFAC...

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FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Several praised the move to delay the final guidance, particularly as a new...

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PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

>Ameet Sarpatwari, J.D., Ph.D., is an Instructor in Medicine at Harvard Medical School, an Assoc...

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Regeneron CEO: Amgen’s disruptive Praluent-blocking patent move hurts patients

FiercePharma, January 10, 2017
by Carly Helfand, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: 

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Now, Regeneron and Sanofi will ask the Federal Circuit “to quickly re...

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Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, January 6, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol...

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If Taxpayers Invent A Drug, Should The Government Just Give It Away?

BuzzFeed News , December 31, 2016
by Dan Vergano, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

The dispute “is not the first time someone has raised questions over NIH&r...

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Medicare Pays For A Kidney Transplant, But Not The Drugs To Keep It Viable

NPR, December 22, 2016
by Richard Harris

The federal government will pay more than $100,000 to give someone a kidney transplant, but after th...

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Senate Aims to Stop Firms From ‘Buying Up Drugs and Jacking Up Prices’

New York Times, December 21, 2016
by Robert Pear

WASHINGTON — On the heels of headline-grabbing price spikes on prescription drugs, a bipartisa...

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Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits

New York Times, December 19, 2016
by Matt Richtel and Andrew Pollack, quoting Rachel E. Sachs (Academic Fellow alumna)

From the article

:

Rachel Sachs, an associate law professor at Washington University in St. Louis an...

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Study: Communities Most Affected By Opioid Epidemic Also Voted For Trump

NPR, December 17, 2016
by Scott Simon, interviewing Shannon Monnat

Voting patterns show that areas where Donald Trump did well were also places where opiate overdoses...

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20 States Accuse Generic Drug Companies of Price Fixing

New York Times, December 15, 2016
by Katie Thomas

The attorneys general in 20 states on Thursday accused six generic pharmaceutical companies, includi...

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The FDA Should Approve Drugs Based on Evidence, Not Emotions

Slate, December 13, 2016
by Alan Levinovitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Unlike many other countries, the United States managed to avoid the thalidomide c...

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Price Poised To Protect Doctors’ Interests At HHS

Kaiser Health News, December 12, 2016
by Christina Jewett and Marisa Taylor

In picking Tom Price to be secretary of Health and Human Services, Donald Trump has chosen an orthop...

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Former Pharma Executives Bribed Doctors To Prescribe Powerful Opioid, Prosecutors Allege

Kaiser Health News, December 9, 2016

KHN Morning Briefing: Summaries of health policy coverage from major news organization

s

The fo...

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Cures Act Gains Bipartisan Support That Eluded Obama Health Law

New York Times, December 8, 2016
by Robert Pear

WASHINGTON — With self-congratulatory zeal and smiles all around, huge bipartisan majorities i...

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HIV ‘game-changer’ now on NHS

BBC News, December 4, 2016
by James Gallagher

A drug that dramatically reduces the risk of being infected with HIV will now be given to patients b...

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Funding for Cures Bill Remains Sticking Point for Health Groups

Bloomberg, November 28, 2016
by Anna Edney and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

The Cures bill will fund some prevention efforts, said Lynne Weil, a spokeswoman...

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Morning View 11-28-16: Pharmaceuticals News

Institute for Clinical and Economic Review's Morning View, November 28, 2016
by Mitchell Stein, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

On Friday, building on the long-standing DC tradition of releasing gargantuan reg...

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House lines up biotech lollipops as support grows for an epic 21st Century Cures Act

Endpoints News, November 28, 2016
by James Carroll, citing Bill of Health blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

According to Kaiser Health News, more than 1,400 lobbyists have ta...

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Lame duck Congress looks for swift approval of massive medical innovation bill

AJC.com (The Atlanta Journal-Constitution), November 27, 2016
by Jamie Dupree, citing Tweet & Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

(Tweet by Rachel E. Sachs) My 1st thoughts on today's draft of 21st Cent...

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Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

Regulatory Affairs, November 16, 2017
by Zachary Brennan, citing Twitter accounts of Rachel E. Sachs (Academic Fellow Alumna), Ameet Sarpatwari, Aaron Kesselheim and Amitabh Chandra (Affilia

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matte...

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Online J-Term Health Law Courses
875 Summit Ave. | St. Paul, MN 55105

Deadline: January 02, 2017

The Mitchell Hamline School of Law Health Law Institute is pleased to offer two online health law co...

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Regulating Off-Label Promotion — A Critical Test

NEJM, November 2, 2016
by Christopher Robertson, JD, PhD (Academic Fellow Alumnus) and Aaron S. Kesselheim, MD, JD, MPH (Faculty Affiliate)

Petrie-Flom Academic Alumnus ;Christopher T. Robertso;and Faculty Affiliate ;Aaron S....

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Proposition 61 Gives California Mandate To Lower Drug Prices, Not Tools

KPBS Midday Edition, October 31, 2016
by Ben Bradford, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Proposition 61 would require Medi-Cal to get VA prices for about 3 million of its...

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Drug prices: Where do we go after the Election?

The Conversation US, October 30, 2016
by Rachel E. Sachs (Academic Fellow Alumna)

Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ag...

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Drug Pricing: Where Do We Go After the Election?

Institute for Public Health, Washington University in St. Louis, October 26, 2016
by Rachel Sachs

From the blog post

:

Martin Shkreli. Valeant Pharmaceuticals. Mylan. Just a year ago, most Americans...

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Health Law Workshop: W. Nicholson Price II

Monday, October 17, 2016 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Presentation: "Regulating Black-Box Medicine

"

This paper is not available for download. To request...

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The Readout: Speaking of Drug Prices

STAT, October 12, 2016
by Damian Garde and Meg Kesh, featuring Rachel Sachs (Academic Fellow alumna)

From the post

:

How? Washington University law professor Rachel Sachs and Department of Veterans Aff...

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Innovation–Innovation Tradeoffs in Drug Pricing

Annals of Internal Medicine, October 11, 2016
by Rachel Sachs (Academic Fellow alumna)

From the article

:

The uproar over the price of the EpiPen is the latest episode in a longstanding c...

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Generic EpiPen Will Likely Secure Profits For Mylan

Law360, September 22, 2016
by Dani Kass, quoting Rachel Sachs (Academic Fellow alumna)

[...] Many customers are still likely to use the branded products once the generic is released,...

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EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

Journal of Law and the Biosciences, September 16, 2016
by Emily A. Largent (Student Fellow alumna)

Abstract

:

In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in...

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EpiPen Maker Quietly Steers Effort That Could Protect Its Price

New York Times, September 16, 2016
by Eric Lipton and Rachel Abrams, quoting Rachel E. Sachs (Academic Fellow Alumnus)

[...] The idea being advanced is simple: If the EpiPen makes the federal preventive l...

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5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the...

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How Mylan cornered the consumer epinephrine market

MedCityNews, September 8, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The New York state attorney general’s office announced Tuesday it will investigate...

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Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are...

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EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

NPR, September 7, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how...

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Missouri law professor: Consider price controls after Epipen controversy

Missourinet, September 5, 2016
by Jason Taylor, quoting Rachel E. Sachs (Academic Fellow Alumna)

A Missouri law professor thinks Congress should consider imposing price controls on certain drugs af...

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Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post

:

Obviously Mylan didn't want to underprice its own branded drug, but it's pos...

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Mylan’s decision to make a cheaper, generic EpiPen ‘baffles’ experts

Business Insider, August 31, 2016
by Lydia Ramsey, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the article

:

"I and others who study these issues full time cannot understand why Mylan though...

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Endpoints News Early Edition

Endpoints News, August 31, 2016
by John Carroll, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the email

:

Don't miss this commentary from Harvard's Rachel Sachs: 

;

I am not sho...

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Mylan’s Lower-Cost EpiPen May Not Hurt Drugmaker’s Sales Much

Bloomberg, August 29, 2016
by Cynthia Koons and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow alumna)

[...] Meanwhile, by introducing its generic, Mylan will set the market price for subsequent com...

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The FDA Wants To Make It Harder To Buy And Sell Poop

BuzzFeed, August 13, 2016
by by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] Depending on how the approval is handed down, Rebiotix could very well put outfits like OpenBi...

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The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine&n...

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This Could Have Been The First Poop Pill To Hit The Market, But It Failed Clinical Trials

BuzzFeed Science, July 29, 2016
by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] “I think it is a big deal,” said Rachel Sachs, a professor of health and law...

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A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:      
; Scholars, advocates, and courts have begun to recogniz...

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Health Insurance as Innovation Incentive

Jotwell, June 9, 2016
by Amy Monahan, reviewing paper by Rachel E. Sachs (Academic Fellow)

Excerpt from the article

:

In Prizing Insurance: Prescription Drug Insurance as Innovation Incentive...

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The Relationship Between Bioethics and U.S. Health Law

In The Oxford Handbook of U.S. Healthcare Law, I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., July 2016 (online), January 2017 (print)
by I. Glenn Cohen (Faculty Director)

>Abstract: ;This chapter explores the way bioethics is taught as part of U.S. health law. It begi... Read More

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Regulatory Affairs Professionals Society, May 19, 2016
by Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)

From the article: 

;

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health L...

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Divided Infringement and the Doctor-Patient Relationship

IP Theory, 2016 (Forthcoming)
by Rachel E. Sachs (Academic Fellow)

>Abstract: ;     
; With its recent en banc decision in Akamai v. Limeligh... Read More

Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

81 Iowa Law Review 1581, 2016
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

>Abstract: ;The Supreme Court recently held that in reverse-payment settlements of drug patent di... Read More

What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article

:

[...] HEALTH WONK RECAP — PULSE flagged a few interesting stu...

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Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract: 

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A problem perennially facing scholars of both intellectual property and health law...

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Promoting Healthcare Innovation on the Demand Side

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract

:

Innovation policy often focuses on the incentives of firms that sell new products. But op...

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Chinese Market Offers New Life to Many Drugs

Dow Jones Business News, March 29, 2016
by Fanfan Wang, quoting I. Glenn Cohen (Faculty Director)

Excerpt from Article

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[...] But the new trend also raises the question of whether China has become...

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Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicis

t

Status: Full Tim

e

File#: 2016-449

4

Dept/Health System: Ethic

s

Site: Trillium...

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Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

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[...] The draft guidance comes as over the past few years, FMT, which basic...

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The ;Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Pe...

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How to Make the Most of Drugs We Already Have

The Upshot, New York Times, February 22, 2016
by By Austin Frakt, citing Ben Roin (Academic Fellow alumnus)

From the articl

e

[...] Moreover, if a drug company cannot ascertain the problem for which a prescri...

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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't attend in person? Learn more about the event

:
  • Learn more about the presentations -...

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Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

>From the article

:

[...] Talk about sending the wrong signals about what sorts of drugs we value mos...

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“FDA in the 21st Century: A Panel Discussion”:

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch a...

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Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article: 

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Most people would agree that it would be better to prevent cancer, if...

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How to Decrease Prices for an Expensive Class of Drugs

The New York Times, November 16, 2015
by Austin Frakt, quoting W. Nicholson Price II (Academic Fellow Alumnus)

Excerpt from the article

:

[...] As the law professors W. Nicholson Price and Arti Rai put it,...

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