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

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 

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. 

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits that NID manufactured, marketed and sold to laboratories throughout the country until 2006. The payment of $302 million will resolve these allegations and represents one of the largest recoveries ever in a case involving a medical device.

A former officer and two employees of Teamsters Local 743 (Local 743) were convicted today in federal court in Chicago of federal labor fraud and theft charges in connection with stealing union ballots in an effort to rig two elections in favor of an incumbent slate of officers in 2004. A federal jury returned guilty verdicts today, after deliberating since April 29, 2009, against the three defendants whose trial began on April 6, 2009.

"We at the Department are especially committed to encouraging compliance with the Act and to fulfilling President Obama's goal of making this Administration the most open and transparent in history."

A federal grand jury in Las Vegas today returned indictments against 10 Nevada-certified emissions testers for falsifying vehicle emissions test reports.

"We must be vigilant in our efforts to safeguard and strengthen the American economy. Our efforts to fight economic crime are a vital component of our broader strategy - a strategy that seeks to foster confidence in our financial system, integrity in our markets, and prosperity for the American people."

"We must invest today to improve public safety in tribal communities. The problems in tribal communities are severe: American Indian and Alaska Native communities suffer from violent crime at far higher rates than other Americans."

The settlement, which will require legislative and judicial approval to become effective, is fair to the plaintiffs, is responsible for the United States, and provides a path forward for the future.

"Although unprecedented challenges and new demands have emerged, our key priorities remain clear," Attorney General Holder said.

Detroit-area resident Emma King pleaded guilty today to engaging in a fraudulent medical testing scheme.

"Today I’ve been asked to report on the Justice Department’s progress, priorities, and goals. I’m proud to tell you what we have accomplished and what we plan to achieve," said Attorney General Holder.

Lobato, 25, pleaded guilty today before U.S. District Court Judge Alan S. Gold in the Southern District of Florida to one count of conspiracy to commit health care fraud.

"I also am personally committed to the restoration and transformation of the Civil Rights Division, as is the Attorney General, whose support of the Division has been unwavering and complete," said Assistant Attorney General Perez.

Young, 56, pleaded guilty to one count of conspiracy to commit health care fraud before U.S. District Court Judge Patrick J. Duggan in the Eastern District of Michigan.

"The Civil Rights Division enforces the Americans with Disabilities Act (“ADA”) and Section 504 of the Rehabilitation Act, and we have a substantial role in implementing Section 508 of the Rehabilitation Act."

"Through our efforts and our partnerships with other Federal agencies and State partners, we will continue to ramp up fair lending enforcement to ensure that all Americans have equal access to credit," said Assistant Attorney General Thomas E. Perez.

"Thank you for this opportunity to discuss the President’s Fiscal Year 2011 Budget for the Department of Justice and to provide an update on the department’s progress, key priorities and future plans," said Attorney General Holder.

"For the Department of Justice, turning the promise of the Olmstead decision into a reality for individuals with disabilities across the nation has become a major component of ADA enforcement," said Assistant Attorney General Thomas E. Perez.

"In the two decades since its enactment, the ADA has revolutionized the way society thinks about individuals with disabilities, and it has transformed the way that people with disabilities live in communities," said Assistant Attorney General Perez.

Carlos Grana, a Miami resident, was also sentenced by U.S. District Judge Lawrence P. Zatkoff in the Eastern District of Michigan to three years of supervised release following his prison term and was ordered to pay $2 million in restitution.

"The Department of Justice is committed to using all available tools in our effort to combat fraud and corruption in the public and private sectors," said Assistant Attorney General Breuer.

Miami-area residents Emilio and Maria Haber and Detroit-area residents Genna Yates and Darryl Nichols pleaded guilty yesterday for their roles in a Detroit-area diagnostic testing fraud scheme.

A Detroit-area patient recruiter was sentenced today to 40 months in prison for his role in a conspiracy to defraud the Medicare program.

The Justice Department today announced a settlement under the Americans with Disabilities Act (ADA) with the National Board of Medical Examiners (NBME), a private, non-profit organization that administers the U.S. Medical Licensing Examination (USMLE), a standardized examination related to medical licensing.

"Today, I come to you on behalf of my colleagues – the more than 117,000 dedicated men and women who serve our nation’s Justice Department in positions and offices all around the world. Above all, I come to you on behalf of my fellow citizens."

W. Scott Harkonen, M.D., the former chief executive office (CEO) of InterMune Inc., was sentenced Wednesday before U.S. District Court Judge Marilyn Hall Patel for wire fraud relating to the dissemination of false and misleading statements about the results of a clinical trial of InterMune’s drug Actimmune.

Wajdi Waked, 25, of Las Vegas, pleaded guilty today before Judge Philip M. Pro of the U.S. District Court in Nevada, to one count of violating the Clean Air Act by falsifying emissions test results.

An owner of a Detroit-area medical clinic was sentenced today to 15 months in prison for her role in a $1.12 million Medicare fraud scheme.

William Joseph McCown, 49, of Las Vegas, was sentenced today before District Judge Lloyd D. George of the U.S. District Court for the District of Nevada.

Mohamad Anas Haitham Soueid, 47, a resident of Leesburg, Va., has been charged for his alleged role in a conspiracy to collect video and audio recordings and other information about individuals in the United States and Syria who were protesting the government of Syria and to provide these materials to Syrian intelligence agencies in order to silence, intimidate and potentially harm the protestors.

The U.S. District Court for the District of Colorado has ordered that Jo Ann Scott be permanently enjoined from using force, threat of force or physically obstructing any person because that person is or has been obtaining or providing reproductive health services.

"I am here today because I understand and appreciate the importance of congressional oversight, and because I am committed to ensuring the highest standards of integrity and professionalism at the Department of Justice," said Attorney General Holder.

"“In response to my call to identify savings across the department, almost $700 million in savings have been developed – funds that are being reinvested in critical mission areas. I also want to note that, in the department’s FY 2013 budget of $27.1 billion, proposed spending increases have been exceeded by proposed cuts," said Attorney General Holder.

"As the 2011 enforcement record illustrates, the Division’s Fair Lending Unit uses every possible tool to address the range of abuses seen in the market, in both mortgage and non-mortgage lending," said Assistant Attorney General Perez.

"Despite the significant fiscal constraints the federal government has faced in recent years, the 116,000 dedicated employees who serve in Department offices around the world have made significant – and, in many cases, historic – progress in safeguarding our citizens from terrorism, violent crime, financial fraud, and a range of threats that often disproportionately threaten the most vulnerable members of society," said Attorney General Holder.

"As someone who spent over a dozen years as a prosecutor and then nearly twenty more as a defense attorney, I know firsthand the importance that discovery plays in ensuring criminal defendants fair trials. But, at the same time, I am acutely aware of the other critical interests – such as the safety and privacy of witnesses and victims – that our criminal justice system properly takes into account," said Deputy Attorney General Cole.

" am proud of the work that’s been done – by the Department’s 116,000 employees, as well as our government and law enforcement partners worldwide – to help fulfill the promises that I made before this Committee more than three years ago," said Attorney General Holder.

"I am proud of all that’s been achieved by the 116,000 men and women who serve the Department in offices around the world. Their dedicated efforts – and those of our government and law enforcement partners at every level – have allowed me to fulfill the commitments that I made during my first appearance before this Committee as Attorney General," said Attorney General Holder.

"The Department’s Olmstead enforcement activities are dynamic and ongoing," said Assistant Attorney General Perez.

"In our system, antitrust and intellectual property policy function together to provide consumers with high-quality products and services at competitive prices, while at the same time preserving strong incentives for the innovation that creates and improves those products," said Acting Assistant Attorney General Wayland.

Miami-area resident Emilio Haber, 53, was sentenced by U.S. District Judge Patrick Duggan in the Eastern District of Michigan in Detroit.

"In the year since I last appeared before this Subcommittee, the Civil Rights Division has continued our vigorous, fair and independent enforcement of civil rights laws. It is fitting that I come before you today, on the 22nd anniversary of the Americans with Disabilities Act, a landmark law that represents a bipartisan tradition of evenhanded civil rights enforcement," said Assistant Attorney General Perez.

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"Today, I am proud to share with you the Division’s recent accomplishments in preventing, punishing, and deterring violent acts of bigotry and hate," said Deputy Assistant Attorney General Austin.

New Mexico-based Akal Security, Inc., one of the largest providers of security services at federal courthouses, agreed to pay $1,875,000 to resolve allegations that it failed to appropriately conduct firearms testing in the Northern District of California.

A federal judge issued an order today allowing the Justice Department to intervene in a disability discrimination lawsuit against the Law School Admission Council (LSAC). The department’s intervention expands the case from a statewide class action limited to California residents to a nationwide pattern or practice lawsuit.