News & Analysis as of

Biden Administration Clinical Trials

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

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

Better Health Care Newsletter - September 2023

Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more

Manatt, Phelps & Phillips, LLP

New FDA Draft Guidance Encourages Industry Focus on Improving Clinical Trial Diversity

Last week, in the midst of the Biden Administration’s coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity. In a...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

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Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

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

Medicare curbs Alzheimer’s drug coverage, fueling regulatory turmoil

As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s...more

Goodwin

Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation

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Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021

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In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 19

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In Washington: President Biden on Thursday doubled to 200 million his administration’s goal for the number of COVID-19 vaccination shots to administer in his first 100 days in office. The U.S. is set to reach Biden’s original...more

King & Spalding

The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities

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On March 8, 2021, President Biden signed an Executive Order, establishing a Gender Policy Council (“the Council”) tasked with the broad policy goal of “advancing gender equity and equality” for the purpose of reducing...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, February 2021 # 16

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In Washington: The House Budget Committee approved legislation for a $1.9 trillion coronavirus relief package on Monday evening, with a full House vote is expected at the end of this week. So far, House Democrats expect a...more

Robins Kaplan LLP

Financial Daily Dose 1.25.2021 | Top Story: Merck Abandons Covid Vaccine Effort Over Ineffective Results

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U.S. drug giant Merck is shuttering its coronavirus vaccine development “after early trial data showed [its pair of vaccines] failed to generate immune responses comparable to natural infection or existing vaccines.” ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 9

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In Washington: President-elect Joe Biden unveiled the first plan to is two-part $1.9 trillion stimulus package calling on Congress to approve $415 billion in emergency spending to scale up vaccinations, testing, and other...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

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