News & Analysis as of

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Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 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

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

King & Spalding

Group of Nearly 60 WTO Members Seek Unprecedented Waiver from WTO Intellectual Property Protection for COVID-related Medical...

King & Spalding on

Companies holding intellectual property in medical products used in the fight against COVID-19 should be aware of formal efforts by a group of nearly 60 developing countries, led by India and South Africa, to obtain a waiver...more

Bradley Arant Boult Cummings LLP

Lessons Learned in the Early Days of Telemedicine Prosecutions: Practical Tips for Defendants Facing Indictments

Last week, Acting Assistant Attorney General Brian C. Rabbitt delivered remarks to lawyers at an annual conference in Washington, D.C. While the remarks included the Justice Department’s annual boasting of significant...more

Womble Bond Dickinson

New blood test to guide personalized cancer treatment

Womble Bond Dickinson on

On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more

The Volkov Law Group

COVID-19: DOJ’s Aggressive Prosecution of Fraud and Pandemic-Related Crimes

The Volkov Law Group on

The Justice Department and the FBI have acted to focus on fraudsters who are preying on the public panic in response to the pandemic.  The Justice Department has alerted US Attorneys’ Offices, and federal, state and local...more

Hogan Lovells

FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19

Hogan Lovells on

On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more

Foley & Lardner LLP

Managing the Commercial Impact of the Coronavirus: FAQs for the Life Sciences Industry

Foley & Lardner LLP on

As the coronavirus outbreak continues to wreak havoc on markets and industries in the U.S. and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges...more

McDermott Will & Emery

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

McDermott Will & Emery on

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Foley & Lardner LLP

2019 FDA Precision Medicine Approvals: Progress At FDA

Foley & Lardner LLP on

On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

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

As medical costs climb, it’s not just drip, drip waste, look at hospital bloat, too

Whether it happens in the drip, drip, drip of costly eye drops or it occurs in the flash of a pricey imaging scan, patients get gouged by modern medicine’s wasteful practices. The inefficiencies can be traced to many and...more

Foley & Lardner LLP

FDA Approves Companion Dx for PD-1 Inhibitor

Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Smart & Biggar

Rx IP Update - December 2016

Smart & Biggar on

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

Mintz - Health Care Viewpoints

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Foley & Lardner LLP

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

Foley & Lardner LLP on

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

King & Spalding

OIG Releases Mid-Year Update to its Work Plan

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On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

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