Cancer

News & Analysis as of

Wrap-Up of Federal and State Chemical Regulatory Developments April 2015

EAB Reverses Epic Penalty In Elementis Case, But Affirms EPA's "Continuing" TSCA Section 8(e) Interpretation: On March 13, 2015, the U.S. Environmental Protection Agency (EPA) Environmental Appeals Board (EAB) reversed the...more

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

GAO Calls for Changes to Medicare Payments to PPS-Exempt Cancer Hospitals

A recent Government Accountability Office (GAO) report, “Medicare: Payment Methods for Certain Cancer Hospitals Should Be Revised to Promote Efficiency,” examines the Medicare reimbursement methodology for cancer hospitals...more

IARC Announces Cancer Classification for Glyphosate and Other Pesticides

On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides....more

HHS Launches New Payment and Delivery Model to Improve Oncology Care

Cancer care is notoriously complex, intensive and costly. With more than 1.6 million people diagnosed with cancer each year, there is a strong impetus towards reforming service delivery. Accordingly, the U.S. Department of...more

Washington Healthcare Update

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA Warning on Hysterectomy Procedure Raises Awareness of Cancer Risk

A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure. ...more

New Obamacare Benefit Mandate Takes Aim at Breast Cancer

Under the Affordable Care Act, insurers and employers that sponsor non-grandfathered medical plans must cover and pay the full cost of specified preventive services in accordance with recommendations issued by the U.S....more

FDA Imposes Firmer Rules on Tanning Salons

The Federal Drug Administration (“FDA”) is tightening rules on tanning salons because of the cancer risk posed by the use of sunlamps. Due to the increased risk of melanoma, future tanning bed designs will include warnings...more

Is J&J Baby Powder Carcinogenic?

The question about whether or not Johnson & Johnson’s Baby Powder contains carcinogens is reportedly about 30 years old. That is alleged in a plaintiffs’ lawsuit against Johnson & Johnson over its Baby Powder claiming there...more

J&J Takes Morcellator Off the Market Due to Cancer Threat

It is not exactly a recall – but Johnson and Johnson (J&J) has removed from the market its Laparoscopic Power Morcellation, a medical device used to break uterine fibroids into little pieces using a cylindrical blade with a...more

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

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

Florida Says Can Do To Medical Cannabis

In the waning days of the 2014 legislative session, the Florida Legislature passed the Compassionate Medical Cannabis Act of 2014. It is a very limited medical marijuana bill with very strict restrictions and conditions on...more

E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors

E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors The dangers of e-cigarettes exposed by a new study showing e-cigarettes can cause cancer and the realization that many of the “safe”...more

Patent Profile: VM Institute of Research Receives Patent for Method of Treating Triple Negative Breast Cancer

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,642,270, which is entitled "Prognostic biomarkers to predict overall survival and metastatic disease in patients with triple negative breast cancer." The...more

ADA Protects Individuals with Cancer, Diabetes, Epilepsy and Intellectual Disabilities

Nearly 34 million Americans diagnosed with cancer, diabetes or epilepsy, and over two million suffering from an intellectual disability are now protected from discrimination under the Americans with Disabilities Act (ADA)....more

Patent Profile: Patent Issued for Method of Differentiating Pancreatic Cancer from Benign Pancreatic Disease

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods." The '983 patent, which is assigned to the Van Andel Research...more

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more

Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...more

Patent Profile: Duke University and Cognosci Receive Patent for Methods of Diagnosing Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,623,601, which is entitled "Methods of diagnosing cancer." The '601 patent, which is assigned to Duke University and Cognosci, Inc. (out of the...more

No, You Can’t Impose An Unknown Regulation On A Hospice Provider And Attempt To Retroactively Deny Payment

In December, 2013, the Pennsylvania Commonwealth Court ruled that a hospice facility’s due process rights were violated when the Department of Public Welfare (“DPW”) imposed an additional requirement without giving notice to...more

Pennsylvania Continues Trend of Stricter Review of Experts in Product Liability and Toxic Tort Cases

For years, plaintiffs in product liability and toxic tort cases have viewed Pennsylvania's state court system as a favorable forum. Over the past year and a half, however, the Pennsylvania appellate courts have issued...more

Oakland Children's Hospital Sued by EEOC for Disability Discrimination

Medical Center Fired Employee with Breast Cancer, Federal Agency Charged - OAKLAND, Calif. - An Oakland-based non-profit regional medical center violated federal law when it failed to accommodate and instead fired an...more

Court Report -- December 08, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astrazeneca AB et al. v. Aurobindo Pharma Ltd. et al. 3:13-cv-07298; filed December 3, 2013 in the District Court of New...more

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