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By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging.  Driven by this increased demand and desire to create positive environmental change, companies are working hard to shift to more sustainable materials and packaging and seeking to communicate such efforts to consumers through product labels and advertising.  “Recyclable.”  “Biodegradable.”  “Made of

The post It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims appeared first on Kleinfeld Kaplan & Becker LLP.

BCC marks the second non-melanoma skin cancer for which Libtayo has demonstrated first-in-class data, the firms note

I am pleased to announce our new 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available for purchase and immediate download.

• Click here to download a free report overview (including the Table of Contents and a List of Exhibits)

• Pharmacy Industry Revenues Hit Record High—Amid Profit Pressures and Amazon Threat, Says New Drug Channels Institute Study (press release)

We’re offering special discounted pricing if you order before March 22, 2020.

The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is a truly unique resource. With 203 proprietary charts, exhibits, and data tables, this 11th edition provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system.

The full document clocks in at 374 pages. I can safely say there is nothing else available that comes close to this report.

The chart below illustrates the depth and breadth of the 2020 edition. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow.


Below, you can read more info and some behind-the-scenes tidbits.

P.S. If you would like to pay by corporate purchase order or check, please email Tamra Feldman. If you preordered the report, you should have already received an email with download instructions. Please contact us if you did not receive the email.
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The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,...

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.

Click to view a price quote on TLRY.

Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)…

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.

The Justice Department today announced the filing of a lawsuit and the settlement of its claims against Fort Bend County, Texas, alleging violations of the Voting Rights Act of 1965, as amended, and the Help America Vote Act (HAVA).

“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising health care costs that all Americans must bear,” said Attorney General Holder.

“Today, we mourn the loss of Dr. Benjamin Hooks, one of our nation’s great civil rights leaders," said Attorney General Holder.

Arturo Fonseca, Isis Torres, Francisco Portillo, Eduardo Romero and William Madrigal pleaded guilty before U.S. District Judge Adalberto Jordan to various health care fraud charges.

"Here, in the church that Reverend King called his home, and in houses of worship across America – his spirit lives," said Attorney General Holder.

A federal court in Los Angeles has permanently barred William Alexander of Pasadena, Calif., and his two companies, Retirement Plan Services Inc. and Lyons Pensions Inc., from selling or administering pension plans or employee welfare-benefit plans.

The Department of Justice announced today that it has resolved claims made by Stephen Ralston against the South Bend, Ind., Public Transportation Corporation (TRANSPO) under the Uniformed Services Employment and Reemployment Rights Act of 1994.

The Justice Department is seeking to block a husband and wife from operating a scheme that allegedly helps high-income individuals attempt to improperly avoid income taxes by funneling money through purported “welfare benefit plans.”

Marubeni Corporation has agreed to pay a $54.6 million criminal penalty to resolve charges related to the Foreign Corrupt Practices Act (FCPA) for its participation in a decade-long scheme to bribe Nigerian government officials to obtain engineering, procurement and construction (EPC) contracts.

"The federal-state agreement contains provisions to ensure that our servicemembers receive the full protection of current law, as well as substantial new benefits," said Assistant Attorney General Perez.

A federal court has permanently barred Tracy L. Sunderlage, Linda Sunderlage and four companies from operating an alleged scheme to help high-income individuals attempt to avoid income taxes by funneling money through purported employee benefit plans, the Justice Department announced today.

"The Fair Sentencing Act is just one example, albeit a very important one, of many I could give you where Criminal Division lawyers and others in the department have worked hard to advance needed legislation and reform an aspect of the criminal justice system in need of repair," said Assistant Attorney General Breuer.

Dr. Shih Chi Liu, 73, of Silver Spring, Md., pleaded guilty before U.S. District Judge James C. Cacheris.

Suiza Dairy has agreed to pay a penalty and make significant upgrades to settle Clean Air Act violations, the Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today.

UBS Securities Japan Co. Ltd. (UBS Japan), an investment bank, financial advisory securities firm and wholly-owned subsidiary of UBS AG, has agreed to plead guilty to felony wire fraud and admit its role in manipulating the London Interbank Offered Rate (LIBOR), a leading benchmark used in financial products and transactions around the world.

RBS Securities Japan Limited, a wholly owned subsidiary of The Royal Bank of Scotland plc (RBS), has agreed to plead guilty to felony wire fraud and admit its role in manipulating the Japanese Yen London Interbank Offered Rate (LIBOR), a leading benchmark used in financial products and transactions around the world.

The Justice Department announced today the filing of a complaint alleging that the County Employees’ and Officers’ Annuity and Benefit Fund of Cook County and Cook County willfully violated the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA) by failing to allow U.S. Army Reserve Member Latoya Hayward to lawfully contribute to her pension for the time she was serving in the armed forces.

Attorney General Eric Holder and Acting Assistant Attorney General for the Office of Justice Programs Mary Lou Leary announced several improvements to the Public Safety Officers’ Benefits (PSOB) Program following the completion of a comprehensive review of the program ordered by the Attorney General in May 2012.

In the Obama administration’s latest step to ensure equal treatment for same-sex married couples following the Supreme Court’s decision to strike down a key section of the Defense of Marriage Act, U.S. Attorney General Eric Holder announced Wednesday that President Obama has directed the Executive Branch to take steps allowing for same-sex spouses of military veterans to collect federal benefits.

St. James Healthcare (St. James), a hospital located in Butte, Mont., and its parent company, Sisters of Charity of Leavenworth Health System (Sisters of Charity), a health care organization based in Denver, Colo., have agreed to pay $3.85 million to resolve allegations that they violated the Anti-Kickback Statute, the Stark Law and the False Claims Act by improperly providing financial benefits to physicians and physician groups that made referrals to the hospital.

The Departments of Veterans Affairs, Defense, Education and Justice, along with the Consumer Financial Protection Bureau and the Federal Trade Commission announced today the launch of a new online complaint system designed to collect feedback from veterans, service members and their families who are experiencing problems with educational institutions receiving funding from Federal military and veterans educational benefits programs, including benefits programs provided by the Post-9/11 GI Bill and the DoD Military Tuition Assistance Program.

A civilian employee of the U.S. Navy posted at the Capodichino Navy Base near Naples, Italy, was arraigned yesterday in Norfolk, Va., for allegedly obtaining more than $360,000 in housing benefits that he was not entitled to receive.

Tracy Mitchell, a resident of Phenix City, Ala., was indicted for her involvement in a stolen identity refund fraud scheme, Assistant Attorney General Kathryn Keneally of the Justice Department's Tax Division and U.S. Attorney George L. Beck Jr. for the Middle District of Alabama announced today following the unsealing of the indictment.

Marubeni Corporation, a Japanese trading company involved in the handling of products and provision of services in a broad range of sectors around the world, including power generation, entered a plea of guilty today for its participation in a scheme to pay bribes to high-ranking government officials in Indonesia to secure a lucrative power project.

Marubeni Corporation, a Japanese trading company involved in the handling of products and provision of services in a broad range of sectors around the world, including power generation, was sentenced today for its participation in a scheme to pay bribes to high-ranking government officials in Indonesia.

William P. Danielczyk Jr., formerly of Oakton, Virginia, pleaded guilty to one count of willful failure to collect and pay over employment taxes for the quarter ending Sept. 30, 2010, and one count of theft or embezzlement from an employee benefit plan for the calendar year 2010, the Department of Justice and Internal Revenue Service (IRS) announced today.

Attorney General Eric Holder released the following statement Tuesday regarding the arrest of Ahmed Abu Khatallah for his role in the attack on the U.S. facilities in Benghazi, Libya

Ahmed Abu Khatallah, aka Ahmed Mukatalah, a Libyan national approximately 43 years of age, has been charged for his alleged participation in the Sept. 11, 2012, attack on the U.S. Special Mission and Annex in Benghazi, Libya, which resulted in the deaths of four Americans

Following the Supreme Court’s historic decision striking down Section 3 of the Defense of Marriage Act, Attorney General Eric Holder on Friday issued a formal report on the yearlong effort by the Justice Department and other federal agencies to implement the decision smoothly across the entire government

Ahmed Abu Khatallah, aka Ahmed Mukatallah, made his first appearance today in the U.S. District Court for the District of Columbia on a federal terrorism offense arising from his alleged participation in the Sept. 11 through 12, 2012, terrorist attacks in Benghazi, Libya, which resulted in the deaths of Ambassador J. Christopher Stevens, Sean Smith, Tyrone Woods and Glen Doherty

An owner of an electrical contracting company pleaded guilty today to falsifying disclosure documents required under the Employee Retirement Income Security Act (ERISA), by intentionally under-reporting hours worked by employees to avoid contractually required contributions to employee benefit plans.

In a settlement with the United States, Consumers Energy, a subsidiary of CMS Energy Corporation, has agreed to install pollution control technology, continue operating existing pollution controls and comply with emission rates to reduce harmful air pollution from the company’s five coal-fired power plants.

Enable trade and investments to generate concrete outcomes for the people.

From : Communities>>Regulatory Open Forum
From a clinical perspective, nothing will make your medical device "safe" as this word is defined in a dictionary.  Different jurisdictions will adopt what are essentially legal definitions of this word. Devices that meet this definition are "safe" only within the scope of that definition, which is more than just the words, but also includes the process the regulatory agency follows to determine whether the device meets that definition.  Two different jurisdictions may adopt the same literal definition, [More]