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Innovation Medical Research

Carlton Fields

[Event] The Heartbeat of Innovation: Tampa's Medical District Initiative - June 4th, Tampa, FL

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Inspired by renowned medical districts in the nation’s greatest cities, Tampa General Hospital and USF Health Morsani College of Medicine have partnered with the Tampa Bay Economic Development Council to create a life...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

Holland & Knight LLP on

President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Manatt, Phelps & Phillips, LLP

What the Hospital-at-Home Movement Tells Us About Igniting Innovation in Health Care

Editor’s Note: In a recent op ed first published in STAT’s First Opinion, James Rebitzer and Robert Rebitzer—coauthors of the new book Why Not Better and Cheaper? Healthcare and Innovation—discuss the innovative...more

Foley & Lardner LLP

NIH Funded Research Centers Support Precision Medicine Research

Foley & Lardner LLP on

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

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

Foley & Lardner LLP on

With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Foley & Lardner LLP

The Health AI Frontier: New Opportunities for Innovation Across the Health Care Sector

Foley & Lardner LLP on

With the health care industry under pressure to improve patient outcomes while controlling costs, artificial intelligence (AI) and machine learning (ML) are quickly becoming indispensable tools. These technologies show...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

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

Manatt, Phelps & Phillips, LLP

[Webinar] Reimagining Medicine: Can Policy Keep Pace With Scientific Advances? - February 1st, 1:00 pm - 2:00 pm ET

Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more

Health Care Compliance Association (HCCA)

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

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

Wilson Sonsini Goodrich & Rosati

2020 Life Sciences Securities Litigation Roundup

2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more

K&L Gates LLP

K&L Gates Triage: ONC Signals Federal Health IT Priorities with 2020-2025 Strategic Plan

K&L Gates LLP on

In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”). Mr. Severson discusses...more

Patrick Malone & Associates P.C. | DC Injury...

FDA reviews go faster — but with less proof drugs are safer or more effective

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

McDermott Will & Emery

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

McDermott Will & Emery on

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more

Hogan Lovells

Poland: New Medical Research Agency

Hogan Lovells on

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish...more

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

Smart & Biggar on

September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

McDermott Will & Emery

Blazing New Trails in Health Care and Technology Innovation Ventures

McDermott Will & Emery on

As the health industry evolves to meet consumer expectations for better quality, lower-cost and more convenient health care options, the demand for technology-driven innovation is accelerating as is the level of interest and...more

Knobbe Martens

The Druggable Microbiome

Knobbe Martens on

Discoveries regarding the role of the microbiome in human health and disease have been emerging with stunning frequency. While each new discovery builds upon the last, occasionally a point is reached at which, in the...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - April 2018

The latest medical news can be dizzying: Medical scientists regularly push new bounds by, for example, targeting cancer treatments based on individual patient genetics. Doctors are applying supercomputing, artificial...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...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

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

McDonnell Boehnen Hulbert & Berghoff LLP

U.S. Trade Representative Issues 2016 Special 301 Report

On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more

McDonnell Boehnen Hulbert & Berghoff LLP

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

King & Spalding

Also In The News - Health Headlines - October 2015 #2

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HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

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