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: 

;

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

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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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Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy

NPR, November 25, 2016
by Sydney Lupkin

The 21st Century Cures Act now being refined by the lame duck Congress is one of the most-lobbied he...

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Surgeon General Murthy Wants America To Face Up To Addiction

NPR, November 17, 2016
by Steve Inskeep, interviewing Dr. Vivek Murthy

In 1964, the U.S. surgeon general released a report on the health impacts of smoking, and it shaped...

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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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One Employer Fights Against Prescription-Drug Abuse:

Wall Street Journal, November 15, 2016
by Rachel Emma Silverman

>This article is behind a paywall. Harvard affiliates can access it via ;Hollis+. 

;

A handfu...

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How Donald Trump May Impact The FDA

Forbes, November 14, 2016
by Jon LaMattina

The election of a new President always sparks discussions around the new policies that the new leade...

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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., May 2016
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: 

;

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

:

[...] 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: 

;

[...] 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: 

;

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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Regulating Secrecy

Washington Law Review, 2015 (Forthcoming)
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:      

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Regulation interacts with intellectual-property excl...

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Salad Days: Professor Jacob Gersen on the rise of food law

Harvard Crimson, September 29, 2015
by Michael Zuckerman, quoting Jacob Gersen (Director, Food Law Lab at the Petrie-Flom Center& Affiliated Faculty)

From the article

:

[...] Much of Harvard Law School now seems hungry to talk about it, too. In addit...

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Heidi Williams wins MacArthur “genius grant”

MIT News, September 29, 2015
by Peter Dizikes, on Heidi Williams (Student Fellow Alumna)

From the article

:

MIT economist Heidi Williams, whose scholarly work looks at the effects of patent...

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How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article

:

To see evidence of this, just look at the behavior of pharmaceutical firms. When...

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How Prescription Drugs Get So Wildly Expensive

WIRED, September 23, 2015
by Nick Stockton, quoting Rachel E. Sachs (Academic Fellow)

From the article

:

[...] With all that in mind, here’s the important question: Is Sh...

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Research Assistants, International Health and Drug Law
Multi-Regional Clinical Trials Center, Brigham & Women's Hospital

Deadline: November 03, 2015

The MRCT Center of BWH and Harvard is seeking one or two research assistants for the Multi-Regional...

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FDA in the 21st Century:

Columbia University Press, September 2015
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director), eds.

Just out from Columbia University Press, ;FDA in the Twenty-First Century: The Challenges o...

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Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

>Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the Na...

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Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus ;Nicholson Price, now an Assistant Professor at the&nbs...

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More than meets the IRB: On human subjects research and regulation: perspectives on the future

More Than Meets the IRB Podcast , May 2015, No. 11
by Holly F. Lynch (Executive Director), I. Glenn Cohen (Faculty Director), Michael Leary

In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen (...

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Countdown to Cures

The Medicine Maker, June 25th, 2015, Issue #0615
by Stephanie Sutton, quoting Rachel Sachs (Academic Fellow)

From the article: 

;

[...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Cent...

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Fall 2015 Course: Drug Product Liability Litigation
Harvard Law School

Deadline: September 08, 2015

Drug Product Liability Litigatio

n

Mr. Peter Gross
i Fall 2015 Cours
e Meets: T, W 5:00pm - 7:00p
...

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“Ending Institutional Corruption” conference, May 1-2

Edmond J. Safra Center for Ethics at Harvard University, April 14, 2015

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in the...

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Health Law Workshop: Rachel E. Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

>Presentation Title: "Rethinking the Incentives/Access Dichotomy: Prescription Drug Reimbursement as... Read More

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

Iowa Law Review, Vol. 81, No. 4, 2016 Forthcoming
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Founding Faculty Director ;Einer Elhauge and four co-authors have just posted a new article ...

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Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the Uni...

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