News & Analysis as of

Cancer

Court Holds International Cancer Agency Is Not A Private Corporation

by Allen Matkins on

More than a half century ago, the World Health Assembly established the International Agency for Research on Cancer as the specialized cancer agency of the World Health Organization. Although headquartered in Lyon, France,...more

The Legality of Cannabidiol and Concerns Regarding False Advertising

by Cozen O'Connor on

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

Precision Medicine Advances: Medicare Coverage of Next Generation Sequencing Testing

by Baker Ober Health Law on

Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more

FDA Approval for Auris' Robotic Endoscopy Platform

by Knobbe Martens on

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics,...more

Coffee Now Served With A Cancer Warning In California

by Husch Blackwell LLP on

Coffee sellers in the State of California will now be required to provide cancer warnings on their coffee products. On March 28, 2018, a California State Court issued a Statement of Decision in a Proposition 65 (Prop 65) case...more

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved...more

CMS Expands Coverage of Certain Advanced Cancer Companion Diagnostic Tests Employing Next Generation Sequencing

Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

A busy month for discrimination law

by Dentons on

It's been a busy few weeks for judgments; we round up the most recent discrimination cases below....more

Obstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for...

by Epstein Becker & Green on

A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more

23andMe Receives First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test

by Knobbe Martens on

On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a subject’s risk of developing specific cancers. 23andMe already...more

Food and Beverage News and Trends

by DLA Piper on

Judge appears to cast doubt on the case against glyphosate. March 14 was the final day of testimony in a hearing before Judge Vince Chhabria of the US District Court for the Northern District of California centering on...more

CMS finalizes National Coverage Determination for Next Generation Sequencing Tests for advanced cancer

by Hogan Lovells on

On Friday, March 16, Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests for Medicare beneficiaries with advanced cancer. Please see...more

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

The Latest in the Prop. 65 World: Processed Meat; Lead and Cadmium in Chocolate; and Glyphosate in Herbicides

by Downey Brand LLP on

February was a busy month in the Proposition 65 world with two developments that may impact businesses that manufacture or sell processed meat or chocolate products. In addition, the United States District Court for the...more

Prop. 65 Litigation Involving Acrylamide Heats Up on Eve of Ruling in Coffee Cases

California Proposition 65 litigation over acrylamide in food has been heating up lately, receiving national news coverage in anticipation of a ruling in a fiercely contested case involving exposure to acrylamide in...more

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

by Knobbe Martens on

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

ASCO Issues Statement on Use of Biosimilars in Oncology

by Goodwin on

The American Society of Clinical Oncology (ASCO) recently issued a statement on use of biosimilars in oncology. According to ASCO, “[a]s many biosimilars come to market in the next several years, their use in oncology will...more

Seattle Genetics Acquires Cascadian Therapeutics, Continuing a Strong 2018 Start in Biotech Mergers and Acquisitions

by Knobbe Martens on

On January 31, two Seattle biotech companies, Seattle Genetics and Cascadian Therapeutics, announced a merger agreement under which Seattle Genetics will acquire Cascadian Therapeutics for $614 million. The announcement...more

Known to the State of California to Cause Cancer or Reproductive Harm – What is Proposition 65 and What You Need to Know

by Cozen O'Connor on

A majority of California voters in 1986 approved a ballot initiative known as Proposition 65, officially titled California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Prop. 65”). Prop. 65 seeks to protect...more

New York Law Extends Statute of Limitations for Failure to Diagnose Cancer

by Harris Beach PLLC on

On January 31, 2018, New York State Governor Andrew M. Cuomo signed into law Senate Bill S 7588-A, which amended the statute of limitations for medical, dental and podiatric malpractice cases where there is an alleged failure...more

Brazilian Society of Clinical Oncology Publishes Position Statement on Biosimilars in Oncology

by Goodwin on

This month the Brazilian Society of Clinical Oncology (SBOC) published a position paper on approval and use issues concerning biosimilars in oncology. The paper, published in the Brazilian Journal of Medical and Biological...more

Prop 65: 9 chemicals added to California’s list for required warnings

by Thompson Coburn LLP on

During 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) added nine compounds to its list of chemicals that product manufacturers are required by law to disclose to consumers. The disclosure...more

South Florida Breast Exams — Mammogram Quality in Question

Mammogram Studies and Their Quality - Medical professionals have debated the frequency and relative age for performing mammogram studies on women; some claiming that once yearly is too often and under 50 years old is too...more

Exercise as Key Component of Treatment for “Chemobrain”

Although the primary focus of this blog is on “traumatic” brain injury, the literature increasingly demonstrates that the physiological causes of cognitive impairment overlap between a range of conditions having...more

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