What Hulu's 'Mrs. America' gets right and wrong about Republican congresswoman Jill Ruckelshaus and evangelical activist Lottie Beth Hobbs in Episode 6.

According to reports, Prince Harry and Meghan Markle are quarantining in a Beverly Hills home owned by "Madea" franchise mastermind Tyler Perry.

Essentially, you surface your first-ever Facebook profile picture — and then nominate three friends to do the same.

In the U.S. almost three quarters use it, along with others such as Instagram and Snapchat. Twenty-four per cent say they’re online almost constantly.

Los Angeles Times journalists Christopher Knight and Molly O'Toole won Pulitzer Prizes on Monday, bringing the newspaper's total to 47.

As many as 20% to 25% of healthcare workers in hard-hit areas, experts say, are likely to develop disorders such as anxiety, depression or post-traumatic stress.

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a pandemic (“Guidance”).  The Guidance provides recommendations that affect adverse event reporting obligations for drugs, biologics, medical devices, combination products, and dietary supplements. To summarize, FDA states in the Guidance that

The post FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics appeared first on Kleinfeld Kaplan & Becker LLP.

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.

This was the first time in a long time that I’ve renewed my nursing license with the thought that I might need it — that I might be needed.

The post Preparing to Go Back to the Bedside During COVID-19: A Nurse-Turned-Bioethicist Reflects appeared first on Bill of Health.

This morning, Alydia Health, a tiny Menlo Park, Calif., startup co-founded by a 21-year-old woman, announced that it has secured $10 million in funding to test a medical device to prevent mothers from bleeding to death after childbirth.

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.
Read more »

First, let me say thank you to all of the healthcare workers who are putting themselves at risk during this crisis.

As I noted last week, many of the crucial issues for our healthcare system will remain after we all get through this challenging period. In that regard, here’s a look at some noteworthy news from the past month:

• Sanofi discloses new data about insulin prices

• Excellent new academic research on list vs. net drug prices

• Three notable researchers overturn their earlier research on drug costs

• Amazon switches PBM vendors for some of its employees

Plus, we unveil the teaser trailer for Drug Channels Video!

P.S. Join the more than 9,000 followers of my daily links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted such topics as:

• How GoodRx shares patients’ prescription data
• 2019 drug trend at Prime Therapeutics
• Controversy about the independent pharmacy market
• A new $5 generic mail order program, Medicare Part D reform
• Retail pharmacy’s future
• Job openings at Amazon 
• Frozen cookie dough
• And much more!

I have also been tweeting many under-the-radar stories about how the coronavirus affects drug channels.
Read more »

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

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.

A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons.

Click to view a price quote on AGN.

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.

The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.

China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.

Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January.

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.

A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order.

The United States has sued a Dallas tax preparer, Tina Preston, her tax-preparation firm – Preston Tax Services, Inc. – and several other individuals associated with the firm, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Dallas with the U.S. District Court for the Northern District of Texas.

The United States has sued a Clive, Iowa, couple to bar them from preparing federal tax returns for others. According to the government complaint, Jill Schwartz-Musin, her husband Howard Musin, and their business, SSC Services, prepare fraudulent federal income tax returns for small business owners.

The United States has sued a Sacramento, Calif., tax preparer, Chris Elmer, his firm – Associated Tax Planners Inc. (ATP) – and several members of his family associated with ATP, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Sacramento with the U.S. District Court for the Eastern District of California.

A federal judge in Pennsylvania has permanently barred Chalamar Muhammad and her husband, Curtis Muhammad, from preparing tax returns for others. Judge Harvey Bartle III of the U.S. District Court for the Eastern District of Pennsylvania entered the order of permanent injunction after the Coatesville, Pa., couple failed to defend against the government’s allegations.

Eduardo Cortez, a resident of Mays Landing, N.J., was sentenced to 36 months incarceration and three years of supervised release by U.S. District Judge Noel L. Hillman in Camden, N.J. According to his plea agreement, Cortez and his employees knowingly prepared false and fraudulent tax returns for customers that included false and inflated deductions, credits and adjustments.

We appreciate the diligent work of the National Research Council’s committee on forensic science in preparing this report. The Department of Justice’s principal focus in dealing with forensic evidence is on applying it dispassionately to law enforcement challenges, and we regularly use forensics to not only convict the guilty, but also to exonerate the innocent.

A federal court in Maine permanently barred Donna L. Hamilton from preparing federal tax returns for others. The court also ordered the Maine resident to provide her customer lists to the government and to mail copies of the court order to her customers. Hamilton consented to the civil injunction order.

DaJuan Jackson, a former tax return preparer in District Heights, Md., was sentenced to 51 months in prison by U.S. District Judge Roger W. Titus for preparing false tax returns for customers.

A federal district court in Tennessee has permanently barred Chattanooga resident Demita Brown-Watkins from preparing federal income tax returns for others. Brown-Watkins agreed to the civil injunction order. According to the government complaint, Brown-Watkins ran her tax-preparation business through two companies—Fastax and Rapid Tax Service—and advertised the “largest refund in town.”

Rodrick Williams, a former tax return preparer from District Heights, Md., was sentenced to 24 months in prison by U.S. District Judge Roger W. Titus for preparing false tax returns for customers.

The Department announced today the resolution of the lawsuit filed by the United States against the state of Vermont to enforce the reporting requirements of the Uniformed Overseas Citizen Absentee Voting Act (UOCAVA). UOCAVA is designed to ensure that members of the uniformed services and overseas citizens may effectively participate in federal elections.

The United States has sued Robert Cusenza, a West Palm Beach tax return preparer, seeking to bar him permanently from the tax preparation business. The government’s complaint asks the court to order Cusenza to stop preparing returns and to turn over his customer list to the Justice Department.

The United States has filed suit against a Jacksonville, Fla., tax return preparer, seeking to shut down her business. According to the government complaint, Shirley Clark, who operates the Nichet Corp., has prepared at least 1,250 federal tax returns for her customers from 2004 until 2007 and, on those returns, Clark has claimed nearly $750,000 in fraudulent fuel tax credits.

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.

A grand jury in the District of Columbia returned a three-count indictment today charging a former staff member in the U.S. House of Representatives with corruption offenses. Fraser C. Verrusio, 39, was charged by the grand jury with conspiring to accept an illegal gratuity, accepting an illegal gratuity, and making a false statement in failing to report his receipt of gifts from a lobbyist and the lobbyist’s client on his 2003 financial disclosure form.

A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers’ non-deductible personal expenses.

Beverly L. Masek, a former elected member of the Alaska House of Representatives, pleaded guilty today to conspiracy to commit bribery.  Masek pleaded guilty before U.S. District Judge Ralph Beistline in Anchorage to one count of conspiracy to commit bribery concerning programs receiving federal funds.

The United States has sued a Fort Richey, Fla., tax preparer, Frank Lighty, and his tax-preparation firm – Lighty & seeking to bar them permanently from the tax preparation business. The civil injunction suit was filed in Tampa with the U.S. District Court for the Middle District of Florida.

The United States has asked a federal court in Savannah, Ga., to permanently bar Ophelia Kelley of Vidalia, Ga., from preparing federal income tax returns for others. According to the government complaint, Kelley operates two return preparation firms in Vidalia – Kelley Tax Service, and City and Country Girl Tax Service.