Global Tobacco Control as a Public Health and Human Rights Imperative

Monday, February 08, 2016 5:00 - 6:30 PM
Lectures and Panels
Hauser 102
Harvard Law School, Cambridge, MA

Please join us for a talk by Professors Howard Kyongju Koh and Harold Hongju Koh regarding the batt...

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Exclusive: FDA preps crackdown on stem cell clinics peddling unproven treatments

STAT, February 8, 2016
by Usha Lee McFarland

LOS ANGELES — Federal regulators are preparing to crack down on scores of clinics a...

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C.D.C. Defends Advice to Women on Drinking and Pregnancy

New York Times, February 5, 2016
by Daniel Victor

The Centers for Disease Control and Prevention defended arecommendation that sexuall...

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Under Pressure, F.D.A. Adds Measures on Opioid Abuse

New York Times, February 4, 2016
by Sabrina Tavernise

Under pressure from Congress to take action amid a worsening opioid epidemic, the Food and Dru...

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Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

Regulatory Affairs, February 3, 2016
by Zachary Brennan, quoting I. Glenn Cohen (Faculty Director)

From the article:

Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, B...

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At House Hearing, Pharma Execs Expected To Argue Price Hikes Affect Hospitals, Not Patients

Kaiser Health News, February 4, 2016

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

But M...

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Rite Aid Shareholders OK Walgreen Deal As CVS Melds Target Pharmacies

Forbes, February 4, 2016
by Bruce Japsen

Rite Aid shareholders this morning overwhelmingly approved the company’s $9 billion sale...

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NAM Releases Report on Mitochondrial Replacement Therapy

Bill of Health Blog, February 3, 2016
by I. Glenn Cohen (Faculty Director)

From the Part II post: 
My last post was a summary of the NAM’s Reco...
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Babies With Genes From 3 People Could Be Ethical, Panel Says

NPR, February 3, 2016
by Rob Stein

Would it be ethical for scientists to try to create babies that have genetic material from three di...

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Health Law Workshop: Michelle M. Mello

Monday, February 01, 2016 5:00 - 7:00 PM
Health Law Workshops
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation Title: "Reforming the Medical Liability System in New York: Outcomes of the New York S...

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Scientists get ‘gene editing’ go-ahead:

BBC News, February 1, 2016
by James Gallagher

It is the first time a country has considered the DNA-altering technique in embryos and approved it.

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Zika Virus a Global Health Emergency, W.H.O. Says

New York Times, February 1, 2016
by Sabrina Tavernise and Donald G. McNeil, Jr.

The World Health Organization declared the Zika virus and its suspected link to birt...

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CDC Endorses A More Effective HPV Vaccine To Prevent Cancer

NPR, February 1, 2016
by Tara Haelle

The updated childhood immunization schedule, released today from the Centers for Disease Control an...

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C.D.C. Ends Chipotle Case With Illness Still a Mystery

New York Times, February 1, 2016
by Christine Hauser

The E. coli outbreaks at Chipotle Mexican Grill restaurants in the United States appear to be over,...

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California Voters Will Have Their Say On Drug Prices

Kaiser Health News, January 29, 2016
by Anna Gorman

California voters will weigh in this November on a high-stakes ballot proposition intende...

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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 mo...

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WHO Urges Action On Obesity As New Studies Link Fat To Bad Health Outcomes

Forbes, January 28, 2016
by Arlene Weintraub

When most people think about the obesity epidemic, they tend to correlate it with skyrocketing rate...

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Obama bans solitary confinement for juveniles in federal prisons

Washington Post, January 26, 2016
by Juliet Eilperin

President Obama on Monday announced a ban on solitary confinement for juvenile offenders in the fed...

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Ed Markey blocks vote on FDA chief over opiate approvals

Boston Globe, January 23, 2016
by Mark Arsenault

US Senator Edward Markey is using Senate rules to block the nomination of a proposed new leader of...

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When the Water Turned Brown

New York Times, January 23, 2016
by Abby Goodnough, Monica Davey, and Mitch Smith

[...] Nearly a year and a half after the city started using water from the long-polluted Flint...

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Kansas Court of Appeals Voids Restrictive 2015 Abortion Law

New York Times, January 22, 2016
by Erik Eckholm

In a split decision, the Kansas Court of Appeals on Friday held that the state Constitution, like t...

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As Zika virus spreads, El Salvador asks women not to get pregnant until 2018

Washington Post, January 22, 2016
by Joshua Partlow

MEXICO CITY — The rapid spread of the Zika virus has prompted Latin American governments...

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Childhood Vaccination Rates Climb In California

NPR, January 21, 2016
by Lisa Aliferis

Maybe it was last January's big measles outbreak at Disneyland that scared more California pare...

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Pharma ‘cash call’ for new antibiotics

BBC News, January 21, 2016
by James Gallagher

More than 80 pharmaceutical companies have called on governments to develop new ways of paying them...

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Solving Pharma’s Shkreli Problem

Forbes, January 20, 2016
by Matthew Herper

[...] Martin Shkreli has a knack of saying exactly the thing that will make people angry. But the i...

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France drug trial:

BBC News, January 17, 2016

A man left brain-dead after an experimental drug trial in France has died, local media report.


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Obama Declares State Of Emergency Over Flint’s Contaminated Water

NPR, January 17, 2016
by Camila Domonoske

Water contamination in Flint, Mich, — where the city switched water sources, causing pipe cor...

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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...

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National Guard Called To Help Provide Safe Water In Flint, Mich.

NPR, January 13, 2016

Six months after high levels of lead were found in the drinking water in Flint, Mich., there have b...

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Implant for Opioid Addicts Urged for Federal Approval

New York Times, January 12, 2016
by Sabrina Tavernise

SILVER SPRING, Md. — A panel of medical experts recommended Tuesday that the Food and Dr...

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IRS: 1.4M Households Failed To Properly Account For Subsidies From Health Law

Kaiser Health News, January 11, 2016

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


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Law on Ultrasounds Reignites Abortion Battle in North Carolina

New York Times, January 10, 2016
by Richard Fausset

RALEIGH, N.C. — A state law requiring that doctors who perform anabortion after the 16th...

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Uncle Sam Just Told Us To Drink Water, Not Soda. You Might’ve Missed It.

NPR, January 9, 2016
by Maria Godoy

[...] Last year, as we reported, a coalition of nutrition scientists and public health ad...

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Health Care Organizations and the Power of Procedure

The American Journal of Bioethics , Vol. 16, Issue 1, January 2016
by Emily A. Largent (Student Fellow Alumna)

From the article:

Rationing refers to “any explicit or implicit measures that allow people t...

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Under Gun Rules, F.B.I. Will Receive Health Data

New York Times, January 6, 2016
by Robert Pear

WASHINGTON — Responding to Republicans who have repeatedly tied gun violence to mental h...

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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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FDA Says Gay Men Can Give Blood — But Only If They Don’t Have Sex for a Year

VICE News, December 22, 2015
by VICE News Staff, quoting I. Glenn Cohen (Faculty Director)

From the article:

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VIC...

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FDA eases blood donation ban on gay men

CBS News, December 21, 2015
by Interview with I. Glenn Cohen (Faculty Director)

The FDA is easing its restrictions on gay and bisexual men who want to make a blood donation. But t...

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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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Euthanasia in Belgium:
The most recent legal developments and policy challenges

Tuesday, November 10, 2015 11:00 AM - 12:15 PM
Lectures and Panels
Conference Room, 1st floor
Harvard Medical School, 641 Huntington Ave. , Boston, MA

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghe...

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FDA’s Pathway for Regulation of Fecal Microbiota Transplants

Journal of Law and the Biosciences, October 26, 2015
by Margaret F. Riley and Bernat Olle, in response to Rachel Sachs (Academic Fellow)

From the article: 

[...] A recent article by Rachel Sachs and Carolyn Edelstein inthe Journal...

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Second Annual HLS-UCLA Food Law and Policy Conference:
Drugs, Animals, and Food: Law & Policy of Antibiotics in the Food System

Friday, October 23, 2015 8:30 AM - 3:30 PM
Pound Hall, Room 102
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA


The debate over antibiotic use in animal agriculture combines elements of science, eth...

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Neuroethics Seminar: Brain Hacking to Boost Your A-Game:
The Ethics of Cognitive Enhancement in Gaming and Competition

Wednesday, October 21, 2015 4:30 - 6:00 PM
Lectures and Panels
Armenise Building, D Amphitheatre
Harvard Medical School, 210 Longwood Ave., Boston, MA

Event Description

This event was free and open to the public. 

Personal enhancement isn'...

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Regulating Secrecy

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


Regulation interacts with intellectual-property exc...

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The Non-Spaces of Medical Tourism

Harvard Design Magazine, S/S 2015, No. 40
by I. Glenn Cohen (Faculty Director)

From the article:

I spent the last six years as a strange kind of tourist. I traveled the globe vi...

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Notice of Proposed Rulemaking to Amend the Federal Policy for the Protection of Human Subjects

by Department of Health and Human Services (and several other federal departments and agencies)

This Federal Register notice from September 2015 outlines proposed changes to the Common Rule. Thes...

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Special Section: Moving Forward in Animal Research Ethics

Cambridge Journals, October 2015

The articles in this special section address a range of issues relating to animal research, law, an...

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Non-Human Primates in Research:
Legal and Ethical Considerations

Wednesday, September 30, 2015 12:00 PM
Lectures and Panels
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA 02138


This discussion explored critical legal, ethical, scientific, and social issues raised...

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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 addi...

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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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At the Frontier: The Ethics of Innovative Surgery
A Neuroethics Seminar Series Event

Thursday, September 10, 2015 4:30 - 6:00 PM
Lectures and Panels
Armenise Building D, Amphitheater
Harvard Medical School, Boston, MA

All modern surgical techniques were once new, so the ethics of surgical innovation is not a new top...

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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 Cen...

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Contrived Threats v. Uncontrived Warnings:

University of Chicago Law Review, Vol. 83, No. 2 (forthcoming 2016)
by Einer R. Elhauge (Founding Faculty Director)

Contractual duress, unconstitutional conditions, and...

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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...

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Complexifying Commodification, Consumption, ART, and Abortion

Journal of Law, Medicine and Ethics , July 2015, Vol. 43, Issue 2
by I. Glenn Cohen (Faculty Director)


This commentary on Madeira's paper complicates the relationships between commo...

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Inbound medical tourism to Barbados:

BMC Health Services Research, July 2015, Vol. 15
by I. Glenn Cohen (Faculty Director) et al.



Enabled by globalizing processes such as trade liberalization, medical...

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Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review:

I highly recommend two recently posted articles on declining innovation incentive...

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Research, Regulation, and Ethics: Discussion of Human Subjects Research Regulation Book

Science for the People Podcast, July 2015, No. 327
by Desiree Schell

About the podcast:

This week we're learning about the regulatory frameworks that try to balanc...

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With The ACA Secure, It’s Time To Focus On Social Determinants

Health Affairs Blog, July 21, 2015
by Lauren Taylor (Student Fellow alumna) and Elizabeth Bradley

From the article: 

While Medicaid expansion remains a dream for Americans in many states, the...

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Existential Suffering and Cura Personalis: Dilemmas at the End-of-Life

CUA Columbus School of Law Legal Studies Research Paper, No. 2015-3, July 1, 2015
by George P. Smith II (past Visiting Scholar)

Existential, or non-somatic suffering, is often assoc...

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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 N...

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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&nb...

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Black Box Medicine

Harvard Journal of Law & Technology, Vol. 28, No. 2 Spring 2015
by W. Nicholson Price II (Academic Fellow alumnus)

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

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Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow Rachel E. Sachs has a new article on the regulatory challenges ...

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Supreme Court Decision in King v. Burwell (2015)

by Supreme Court of the United States

Read the Supreme Court's 2015 decision upholding the Constitutionality of federal insuranc...

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A New Chapter by Faculty Director I. Glenn Cohen,

Edward Elgar Publishing, 2015
by Edited by Neil Hunt, Daniel Horsfall and Johanna Hanefeld

Faculty Director I. Glenn Cohen has authored a new chapter on medical tourism in the...

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Visible Solutions:
How Neuroimaging Helps Law Re-envision Pain

Saturday, June 06, 2015 8:00 AM - 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA


Can brain imaging be a “pain-o-meter” that tells courts when a person is i...

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Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

New York Times, May 21, 2015
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Faculty Director I. Glenn Cohen has co-authored an op-ed for the New York Times on the FD...

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Congress seeks to quash patent trolls

Nature News, May 20, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article:

Predatory ‘patent trolls’ could soon find it harder to operate in th...

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2015 Annual Conference
Law, Religion, and Health in America

Saturday, May 09, 2015
Wasserstein Hall, Milstein East BC
1585 Massachusetts Ave., Cambridge, MA

Join the conversation on Twitter! @PetrieFlom #lawreligionhealth

To request copies of se...

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Drug Product Liability Litigation Course


Drug Product Liability Litigation Course
Harvard Law School

Deadline: Open until filled.

Instructor: Mr. Peter Grossi

Semester: Fall 2015 Course

Meets: T, W 5:00pm - 7:00p.

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Innovation Law and Policy:

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of pers...

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What Does Indiana’s Religious Freedom Law Mean For Health Care?

Health Affairs Blog, April 21, 2015
by Holly Fernandez Lynch (Executive Director)

Executive Director Holly Fernandez Lynch spoke on the impact of the Hobby Lobby decision...

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Review of Human subjects research regulation: perspectives on the future

Theoretical Medicine and Bioethics, Vol. 36, Issue 2, April 2015
by Lydia Stewart Ferreira (Visiting Scholar)

Petrie-Flom Visiting Scholar Lydia Stewart Ferreira, currently Adjunct Professor at...

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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 th...

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Health Law Workshop: Rachel E. Sachs

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

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

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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&nbs...

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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 Un...

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Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy:

Science, April 10, 2015
by I. Glenn Cohen (Faculty Director), with Eli Adashi and Julian Savulescu

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regu...

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Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

MedicalXpress, April 10, 2015
by Bob Yirka, citing I. Glenn Cohen (Faculty Director) et al.

Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adash...

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Is UK evaluation of reproductive tech a model for US?

MedicalXpress, April 10, 2015
by David Orenstein, citing I. Glenn Cohen (Faculty Director) et al.

When the United Kingdom resoundingly approved mitochondrial replacement therapy in Februa...

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FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Thursday, April 09, 2015 12:00 PM
Lectures and Panels
Griswold Hall, 110
Harvard Law School, 1525 Massachusetts Ave., Cambridge, MA

Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussed the balance between sp...

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