Members of the Energy and Commerce Committee’s Health and Oversight and Investigations subcommittees today held a bipartisan teleconference forum with Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat, M.D., to discuss racial disparities in health outcomes for COVID-19 patients. Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released a joint statement following the call: “Today, bipartisan members of our two subcommittees discussed the deeply troubling racial disparities in health outcomes for COVID-19 patients with CDC’s Principal Deputy Director Schuchat.  During the call, members received an update on CDC’s COVID-19 response, current data collection efforts, and reiterated the need for more accurate and timely demographic data.  “Congress stands ready to work with the CDC to secure comprehensive demographic data to help us direct resources and support to close this gap in these health outcomes.” ###

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.

Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan…

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.

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.

Today, Safe Shores is a model of public-private collaboration at its best, an example for Child Advocacy Centers across – and beyond – the country, and a critical partner in the work of seeking and administering justice.

Richard Jaensch, a resident of Annandale, Va., has been indicted by a Alexandria, Va., federal grand jury with one count of corruptly endeavoring to impede the Internal Revenue Service (IRS), one count of filing a false claim for a refund and four counts of failing to file a tax return for 2004 through 2007.

Oddie Tribble, 51, a former deputy sheriff with the Kershaw County, S.C., Sherriff’s Office, was sentenced to 63 month in prison and three years of supervised release by U.S. District Judge Cameron McGowan Currie for using excessive force on a man in his custody on Aug. 5, 2010.

Kirby Dollar, 37, a former detective with the Russell County Sheriff’s Office, pleaded guilty in federal court in Montgomery, Ala., for his role in the assault of a handcuffed man.

The Department of Justice announced today that it will require Cumulus Media Inc., one of the largest operators of radio stations in the United States, to divest three radio stations in two markets in order for Cumulus to proceed with its acquisition of Citadel Broadcasting Corporation.

The complaint and consent decree were filed today in accordance with an agreement with the defendants resolving numerous violations of the Food, Drug and Cosmetic Act.

"The Access to Justice office represents an unprecedented commitment by this Administration to addressing our indigent defense system, to growing pro bono service opportunities, and – ultimately – to strengthening our entire legal system," said Senior Counselor Mark Childress.

The seven-count indictment alleges that Michael Moore, 44, of Chadds Ford, Penn., infringed the copyright protected works during seven six-month periods between May 2006 and June 2010.

Kirby Dollar and Timothy Watford, former deputies with the Russell County, Ala., Sheriff’s Office, were sentenced in federal court in Montgomery, Ala., for their participation in the beating of a handcuffed man who had been taken into official custody.

The U.S. Justice Department and the U.S. Attorney’s Office for the Western District of Washington announced today that they are closing the federal criminal civil rights investigation of a former Seattle Police Department Officer for the fatal shooting of the late Native American woodcarver John T. Williams, and that charges will not be filed.

Enyinnaya Udo was sentenced to 24 months in prison today and ordered by U.S. District Judge Barbara J. Rothstein to pay more than $262,966 in restitution to the Internal Revenue Service (IRS) as a condition of supervised release, the Justice Department and IRS announced.

The U.S. District Court for the District of Columbia has entered judgment for more than $17 million against Dr. Ishtiaq Malik and his two companies, Ishtiaq Malik M.D., P.C. and Advanced Nuclear Diagnostics, for submitting false nuclear cardiology claims to federal and state health care programs.

Christopher Eugene Reynolds, 39, a former police officer of the Selmer, Tenn., Police Department (SPD), pleaded guilty today in the U.S. District Court for the Western District of Tennessee to violating the civil rights of an arrestee, the Justice Department announced.

The Department of Justice announced today that a federal grand jury in the Middle District of Alabama has returned an indictment against J. Keith McCray, a criminal investigator with the Macon County, Ala., Sheriff’s Office for violating the rights of a man he unlawfully seized and assaulted.

J. Keith McCray, a criminal investigator with the Macon County, Ala., Sheriff’s Office, pleaded guilty in federal court today to assaulting a handcuffed man at the county jail, resulting in bodily injury to the victim.

You know as well as anyone that the challenges we face are daunting. You’ve shown us that, as we seek to address the problem of substance abuse, it makes sense to focus on the most dangerous types of drugs. And right now, few substances are more lethal than prescription opioids and heroin.

The Department of Justice announced today that it will require Sinclair Broadcast Group and Perpetual Corp. to divest their interests in WHTM-TV, an ABC affiliate in Harrisburg, Pennsylvania, in order to proceed with Sinclair’s proposed $963 million acquisition of Perpetual

J. Keith McCray, previously a criminal investigator with the Macon County, Alabama, Sheriff’s Office, was sentenced today by Judge Myron H. Thompson to serve 36 months in prison and two years of supervised release for assaulting a handcuffed man at the county jail, announced the Justice Department and the U.S. Attorney’s Office for the Middle District of Alabama.

Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

Youâve likely heard of life hacks, which are tricks or shortcuts that help you be more efficient in life. You may or may not have heard of biohacks. But chances are, youâve already tried some without even knowing it. You might even be biohacking right nowâ

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

The Maximus call center was accused by a whistleblower of failing to practice what it hired workers to preach.

Camille François is a leading investigator of disinformation campaigns and author of the well-known "ABC" or "Actor-Behavior-Content" disinformation framework, which has informed how many of the biggest tech companies tackle disinformation on their platforms. Here, she speaks with Lawfare's Quinta Jurecic and Evelyn Douek for that site's series on disinformation, "Arbiters of Truth." Earlier this…

Camille François is a leading investigator of disinformation campaigns and author of the well-known "ABC" or "Actor-Behavior-Content" disinformation framework, which has informed how many of the biggest tech companies tackle disinformation on their platforms. Here, she speaks with Lawfare's Quinta Jurecic and Evelyn Douek for that site's series on disinformation, "Arbiters of Truth." Earlier this…

Find out what steps the CDC is taking to prevent a massive Zika virus outbreak in the United States.

Camille François is a leading investigator of disinformation campaigns and author of the well-known "ABC" or "Actor-Behavior-Content" disinformation framework, which has informed how many of the biggest tech companies tackle disinformation on their platforms. Here, she speaks with Lawfare's Quinta Jurecic and Evelyn Douek for that site's series on disinformation, "Arbiters of Truth." Earlier this…