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Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with...

Maynard Nexsen on

Ming-Wei Chen and Fanheng Zhou, the scientists behind RephImmune, join hosts Lynnsey and Matthew to discuss how their biotech startup is developing a next-generation cell therapy platform designed to overcome the limitations...more

Spilman Thomas & Battle, PLLC

The Story of Henrietta Lacks and the Biotechnology Company Accused of Selling Her Cells for Profit

Spilman Thomas & Battle, PLLC on

Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this...more

Faegre Drinker Biddle & Reath LLP

Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Faegre Drinker Biddle & Reath LLP on

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case...more

McDonnell Boehnen Hulbert & Berghoff LLP

Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance

McDonnell Boehnen Hulbert & Berghoff LLP on

Chemotherapeutic drug resistance is one reason cancer remains an unsolved clinical problem despite the efforts ever since President Nixon declared his "War on Cancer" in 1971.  Cancer cells, due in part to the genetic...more

Wilson Sonsini Goodrich & Rosati

Companies with New Cancer Drug Candidates Should Plan Now for August 2020

Wilson Sonsini Goodrich & Rosati on

Requirement for a Pediatric Clinical Investigation - Starting on August 18, 2020, any drug company submitting an original application for a first-to-be approved or licensed cancer drug that: - is indicated for an adult...more

Wilson Sonsini Goodrich & Rosati

FDA Launches Expanded Access Experimental Cancer Drug Project

Wilson Sonsini Goodrich & Rosati on

In the U.S., patient access to investigational cancer drugs—outside of clinical trials licensed by the U.S. Food and Drug Administration (FDA)—has historically proven insurmountable for most patients for at least the...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...

Wilson Sonsini Goodrich & Rosati on

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

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

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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

Foley Hoag LLP

2013-2014: Evolving Challenges for Value-Priced LDTs

Foley Hoag LLP on

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

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