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Holland & Knight LLP

Senate Releases Bipartisan AI Roadmap

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A group of four bipartisan senators known as the Bipartisan Senate Artificial Intelligence (AI) Working Group (Working Group) on May 15, 2024, released "Driving U.S. Innovation in Artificial Intelligence: A Roadmap for...more

King & Spalding

The Administration Takes Aim At Drug Prices Again – This Time Through A Controversial Framework for Exercising March-In Rights

King & Spalding on

The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more

Foley & Lardner LLP

NIH Funded Research Centers Support Precision Medicine Research

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Somatic mosaicisms are post-conception changes to cellular DNA that lead to genetic variation among cells in an organism. These changes can account for variation among individuals’ health or disease progression. Therefore, an...more

Manatt, Phelps & Phillips, LLP

[Webinar] The NCATS Alliance: Speeding the Process of Bringing New Treatments to Patients - March 15th, 1:00 pm - 2:00 pm ET

Manatt, Phelps & Phillips, LLP on

Featuring Francis Collins, M.D., Ph.D., Senior Advisor to President Biden and Former Director of the National Institutes of Health, and Joni Rutter, Ph.D., NCATS Director, Plus a Panel of Health Care Leaders From Pfizer,...more

Health Care Compliance Association (HCCA)

ARPA-H Begins to Take Shape Amid Questions About Scope, Mission, Overlap With NIH

Health Care Compliance Association (HCCA) on

Report on Research Compliance 19, no. 7 (July, 2022) - NIH’s highest ranking external advisory committee had just heard a spirited, hour-long explanation about the agency’s Advanced Research Project Agency for Health...more

MoFo Life Sciences

CURES 2.0: WILL IT BE BETTER THAN THE ORIGINAL?

MoFo Life Sciences on

It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of...more

McCarter & English Blog: Government Contracts...

NIST On Track To Clarify Bayh-Dole To Ensure High Prices Cannot Be Used As Grounds For Exercising March-in Rights – Or Is It?

McCarter & English Blog: Government Contracts... on

On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Foley & Lardner LLP

Precision Medicine - Even Medicare Will Pay for It!

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President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

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