News & Analysis as of

Research and Development Coronavirus/COVID-19

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Womble Bond Dickinson

The Evolution of Vaccinology: From Humble Beginnings to Advanced Science

Womble Bond Dickinson on

For centuries, humans have sought ways to protect from deadly diseases. The practice of intentionally exposing healthy people to smallpox, a practice known as variolation, likely began as early as 200 BCE. ...more

Cozen O'Connor

Broad Street Brief: Council Investigates City’s Carbon Neutrality Efforts

Cozen O'Connor on

A Preview of Mayor Parker’s First Budget Proposal Mayor Cherelle Parker will present her first budget plan next week, which is expected to focus largely on her campaign promises to make Philadelphia safer, cleaner, and...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

McDonnell Boehnen Hulbert & Berghoff LLP

International Trade Commission Issues Report of COVID-19 IP Waiver

It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Sandoz Biosimilar for Tysabri®

It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs.  See "Trump...more

K2 Integrity

Post-Pandemic Era: Understanding the CHIPS and Science Act of 2022 and Its Impact on the Construction Industry

K2 Integrity on

The COVID-19 pandemic created unprecedented challenges in technology, with the demand for equipment increasing dramatically as the world quickly transitioned into remote operations. During this time, the United States’...more

MoFo Tech

AI Trends For 2023 - Bioinformatics

MoFo Tech on

From improving genomic sequencing to discovering new drug formulations, AI plays a key role in advancing biomedical research. In particular, the field of bioinformatics, which involves the collection and interpretation of...more

Hogan Lovells

Zniesienie Stanu Epidemii – Skutki Dla Podmiotów Gospodarczych

Hogan Lovells on

Stan epidemii w związku z COVID-19 wprowadzono w Polsce 20 marca 2020 roku. Z dniem 16 maja 2022 roku, stan epidemii w Polsce został zniesiony i zastąpiony stanem zagrożenia epidemicznego. Podstawą prawną dla tej zmiany było...more

Hogan Lovells

Lifting the state of epidemic - effects on economic entities

Hogan Lovells on

The state of epidemic for COVID-19 was introduced in Poland on 20 March 2020. As of 16 May 2022, the state of epidemic in Poland was lifted and replaced by the state of epidemic emergency. The legal basis for this change was...more

Mintz

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

Mintz on

As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

AEON Law

Patent Poetry: Dispute over COVID Vaccine Shows Importance of Inventorship

AEON Law on

Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

Maynard Nexsen on

Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 11. In This Month’s E-News: November 2021

Report on Research Compliance 18, no. 11 (November, 2021) - A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...more

Goodwin

Navigating The New Normal: Disruption And Reinvention: The Pivot to Local Supply Chains

Goodwin on

It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Research Integrity ‘Whistleblower’: Don’t Ignore Outsiders, Train Senior Investigators

Report on Research Compliance 18, no. 7 (July 2021) - Elisabeth Bik will not be silenced. While Bik, who has a doctorate in microbiology, has been active in calling out fraudulent research for several years, she gained...more

King & Spalding

Biden Administration Issues 100-Day Supply Chain Report

King & Spalding on

Industry-Specific Primer – Semiconductor Manufacturing And Advanced Packaging - On June 8, 2021, the Biden Administration issued the reports mandated by the Executive Order on America’s Supply Chains (the “America’s Supply...more

Foley & Lardner LLP

Foley Weekly Automotive Report - May 2021 - 4

Foley & Lardner LLP on

This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Fitch Ratings and AutoForecast Solutions estimate a global production...more

McDonnell Boehnen Hulbert & Berghoff LLP

Science Does Not Support the Latest COVID Hysteria

In a time of a global pandemic, with antivaxxer and anti-science sentiments running rife, and when combinations of fear, distrust, and paranoia are rampant, it is easy for important results from basic science to become fodder...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

McDonnell Boehnen Hulbert & Berghoff LLP

Evolution of SARS-CoV-2 from Bat to Human Pathogen

A recent COVID post elicited the comment that we were just a "ray of sunshine."  Following in this tradition, this post concerns a recent report, in PLOS Biology, that the evolution of the SARS-CoV-2 virus (which causes...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Wayne A.I. Frederick (transcript)

Our “Innovation Conversations” series continues with President of Howard University Dr. Wayne A.I. Frederick. Sterne Kessler Director Trey Powers and Director of Marketing and Communications Kathryn Holmes Johnson (HU Class...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Wayne A.I. Frederick

Our “Innovation Conversations” series continues with President of Howard University Dr. Wayne A.I. Frederick. Sterne Kessler Director Trey Powers and Director of Marketing and Communications Kathryn Holmes Johnson (HU Class...more

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