When Your Dreams of Motherhood Are Destroyed

Marie Claire, October 1, 2018
Kayla Webley Adler, quoting I. Glenn Cohen (Faculty Director)

From the article:  Neither major political party is expected to push for more regulation. Democrats aren’t likely to touch fertility because of how close the issue is to the abortion debate. “Any attempt to regulate reproductive technology almost…

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The Health 202: Trump vowed drug companies would lower prices. That hasn’t happened yet.

The Washington Post, October 1, 2018
Paulina Firozi, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  The AP found in the two months after Trump’s prediction of major cuts,  price increases outpaced decreases by a 16.5-to-1 ratio. During that time there were 395 price increases and 24 decreases.…

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Yes, PTAB proceedings against Orange Book patents are on the up. No, they’re not wiping them out

IAM Media, October 1, 2018
Adam Houldsworth, featuring work by Jonathan Darrow

From the article: Further data has emerged showing that the Patent Trial and Appeal Board (PTAB) is far from the “death squad” that many in the US life sciences industries fear that it may be becoming. A…

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Gilead to launch authorized generics of two HCV drugs: The goal is to remain competitive while lowering the cost for patients

Chemical and Engineering News, September 26, 2018
Lisa M. Jarvis, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The effect on costs for patients and overall spending remains to be seen. “It’s unlikely this will result in lower government spending because this is what governments were approximately paying already,” says Rachel…

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Petrie-Flom Center and Edmond J. Safra Center for Ethics Fellow-in-Residence: The Ethics of Technological and Biomedical Innovation

Petrie-Flom Center, Applications Due: November 15, 2018

Each year the Edmond J. Safra Center for Ethics at Harvard University hosts several fellows-in-residence. For 2019-20, they are concentrating their fellowships on the Ethics of Technological…

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Researchers Point to R&D Treaty to Spur New Infectious Disease Treatments

RAPS Regulatory Focus , September 24, 2018
Zachary Brennan, quoting Jonathon Darrow (Student Fellow Alumnus)

From the article:  As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper suggest forming a research and development…

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Smart pills can transmit data to your doctors, but what about privacy?

New Scientist, September 19, 2018
I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)

From the article:  Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food and Drug Administration (FDA), in November 2017. Its roll-out…

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A pharma exec raised the price of antibiotic by 400 percent — and the government can’t do much about

Stat Plus, September 11, 2018
Ike Swetlitz and Nicholas Florko, quoting Rachel Sachs (Academic Fellow Alumnus)

From the article:  Three years after Martin Shkreli became the poster boy of pharmaceutical company greed, another drug company executive is setting himself up for a similar infamy. And now, just as then, there is little the government…

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Capitol Checkup: Medicare indication coverage; pre-existing conditions battle

S&P Global Market Intelligence, September 4, 2018
Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  "Allowing for indication-based coverage could result in some drugs not being available for some indications, but it could also result in drugs that aren't being covered now becoming available for higher-value uses," Coukell…

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A Setback For Massachusetts In States’ Drive To Contain Medicaid Drug Spending

NPR Shots/WBUR, September 12, 2018
Martha Bebinger, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  States serve as "laboratories of democracy," as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals. …

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Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents

Intellectual Property Watch, September 6, 2018
William New, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the Patent Trial and Appeal Board (PTAB) process. …

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Generic Drugmakers Embrace Inter Partes Review Process

RAPS Regulatory Focus , September 4, 2018
Zachary Brennan. quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  [Generic Drugmakers Embrace Inter Partes Review Process]Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced a new process, known as inter partes review (IPR),…

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Is Medical Tourism Safe?

The Doctors, featuring I. Glenn Cohen (Faculty Director)

The Doctors welcomed Medical Tourism Association President Renee-Marie Stephano and Harvard professor and author of “Patients with Passports” Glenn Cohen to discuss just how safe going to other countries for medical procedures is.

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Listening to NFL Players On Mental Health: New report highlights key findings from interviews with players and family members

Journal of Clinical Sport Psychology, Volume 12 Issue 3, September 2018
Sarah A. McGraw, Christopher R. Deubert, Holly Fernandez Lynch, Alixandra Nozzolillo, Lauren Taylor, I. Glenn Cohen (Faculty Director)

When it comes to their careers, current and former NFL players express satisfaction – and frustrations – about their lives both on and off the field. “Life on an Emotional Roller Coaster: NFL Players and Their Family Members’ Perspectives on Player Mental Health” covers…

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Petrie-Flom is Hiring! Call for Applications: Petrie-Flom Center Student Internship Program

Petrie-Flom Center, September 2018

General information The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the Fall 2018. Availability to start immediately…

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Who’s to blame when a machine botches your surgery?

Quartz, September 10, 2018
Robert David Hart (quoting W. Nicholson Price II, Academic Fellow Alumnus)

From the article:  Determining the levels of legal responsibility for AIs as a whole is a fairly new area and one that has yet to be seriously tested in court. What’s more, in a health care context, AIs’ current status as “decision aides”…

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Petrie-Flom Welcomes 2018-2019 Student Fellows

Petrie-Flom Center, September 10, 2018

We are so excited to welcome a new crop of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from Harvard Law School, the…

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FDA confronts its limits in push on drug pricing

Biopharmadive, August 27, 2018
Ned Pagliarulo, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market entry. In the case of Humira, a low-cost option likely won't…

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Drug Prices in Ads: Senate Passes Amendment

RAPS Regulatory Focus, August 24, 2018
Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Earlier this month, CMS also announced plans to begin using what’s called step therapy to try to lower the spend on Part B drugs by about 20% in Medicare Advantage plans. The announcements are beginning to add up to a wider…

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HHS offers scant evidence Trump’s drug blueprint putting brakes on price hikes

S&P Global Market Intelligence, August 22, 2018
Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Health and Human Services provided scant evidence, filled with caveats, to back up its chief's claim that drugmakers were responding to the Trump administration's plan to lower Americans' costs for prescription medicines by…

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