Meeting Cancer Reporting Requirements
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 136: Dr. Amy Curtis, Radiation Oncologist, Gibbs Cancer Center & Research Institute
The Rare Air of Elevation Oncology: Raising Nearly $200M in 2 Years, with CEO Shawn Leland
Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more
On July 14, 2023, the World Health Organization (WHO) published a summary of two findings regarding aspartame, an artificial sweetener found in many consumer products. One finding categorized aspartame as “possibly...more
The NIH is Soliciting Research on How Cannabinoid Signaling Influences Cancer Biology - There is a recognized need for more research on how cannabis derivatives can be used for therapeutic purposes. As part of a growing...more
Thank you for reading the May 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss Spotify's exploration into NFTs, two new USPTO policies with practical implications for trademark applicants...more
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
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
We’ve been talking about telehealth and mental health this week. Here’s both combined in one interesting and highly valued announcement today, followed by several tests – well, 3 million COVID tests a week to be exact, and,...more
Clinical manifestations of head and neck cancers often occur only after the disease has reached an advanced stage. Development of new technology for earlier diagnosis is of critical importance. Since the nasopharynx, base of...more
No painful procedure or biopsy needed. We can test our blood to diagnose and even predict cancer. The Human Genome Project, a joint effort between the U.S. Department of Energy and the National Institutes of Health, began...more
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
Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design and recruitment methods,...more
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been...more
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
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
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
The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law,...more
To assist the International Agency for Research on Cancer (IARC) in selecting agents for review in future Monographs, IARC regularly convenes international, interdisciplinary Advisory Groups to review all public nominations...more
The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more
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
A well-known research university and some excitable journalists have sown confusion about prostate cancer and the value of the PSA screening test. The mess can be traced to a study by physicians from Northwestern University...more
An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations...more
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
On July 30, 2013, the United States Attorney’s Office for the Northern District of Illinois announced that Northwestern University entered a settlement agreement to pay the United States $2.9 million to settle False Claims...more
Last month, the American Association for Cancer Research (AACR) announced that researchers at the National Cancer Institute (NCI) had generated a data set of cancer-specific genetic variations, which the researchers were...more