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Public Health Biotechnology

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Six

On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more

Hogan Lovells

JPM panelists see opportunities under new U.S. regulators for venture capital and investing in emerging life sciences fields

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The outcome of the 2024 U.S. election had far-reaching implications for the global investment landscape, especially in the dynamic field of venture capital and early-stage investing. Speaking at the J.P. Morgan Healthcare...more

Jones Day

Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

Jones Day on

The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more

Goodwin

White House Announces “Bold Goals” for Biotech

Goodwin on

In a report entitled “Bold Goals for U.S. Biotechnology and Biomanufacturing,” the White House recently announced several biotech-related “bold goals” to advance the environmental, agricultural, economic, health, and science...more

Goodwin

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

Goodwin on

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

Arnall Golden Gregory LLP

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: Learning from the Past

As we continue to discuss the ethical considerations related to the distribution of a safe and effective coronavirus vaccine, it is important to consider lessons learned from other pandemics. Though the particular facts of...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: The Basics

Before we continue our Bioethics in a Pandemic series, we thought it would be helpful to provide a quick overview of the various principles that inform ethical decision-making in the health care setting. As you might...more

Hogan Lovells

COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct

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On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

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The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Morgan Lewis

Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries

Morgan Lewis on

The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Hogan Lovells

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

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FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

Hogan Lovells

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

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On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

Hogan Lovells

FDA Releases Plant and Animal Biotechnology Innovation Action Plan

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The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more

Hogan Lovells

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

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Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

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