The Department of Justice and the Consumer Financial Protection Bureau (CFPB) today announced the federal government’s largest auto loan discrimination settlement in history to resolve allegations that Detroit-based Ally Financial Inc. and Ally Bank have engaged in an ongoing nationwide pattern or practice of discrimination against African-American, Hispanic and Asian/Pacific Islander borrowers in their auto lending since April 1, 2011.

Conrad Alvin Barrett, 27, has been charged with a federal hate crime related to a racially-motivated assault of a 79-year-old African American man.

A patient recruiter for a fraudulent Miami-area mental health company, American Therapeutic Corporation (ATC), pleaded guilty today for her participation in a $190 million Medicare fraud scheme.

U.S. Attorney General Eric Holder on Thursday urged Congress to pass the bipartisan Smarter Sentencing Act, introduced by Senators Dick Durbin and Mike Lee.

Three Miami residents have been indicted for their alleged participation in a $190 million Medicare fraud scheme.

A former Guatemalan Special Forces officer was sentenced today to serve 10 years in prison for covering up his involvement in a 1982 massacre at Dos Erres, Guatemala.

The Civil Rights Division and U.S. Attorney’s Office for the Central District of California announced that two Latino men associated with the Compton 155 street gang were sentenced today by U.S. District Judge Terry J. Hatter Jr. for their racially-motivated attack on African-American juveniles at a residence in Compton, Calif., on Dec. 31, 2012.

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration.

Omnicare Inc., an Ohio-based long-term care pharmacy, has agreed to pay the government $4.19 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act.

It’s a special privilege to share the stage with Deputy Marshal [Kirk] Bowden, who, as we’ve just heard, stood on the literal front lines of this fight during a critical moment in the Civil Rights Movement – at a time when young students, law enforcement officials, National Guardsmen, and brave citizens risked their lives to integrate historic institutions across the Deep South.

A federal jury in Houston today convicted two owners of a former Houston mental health care company, Spectrum Care P.A. (Spectrum), several of its employees and the owners of certain Houston group care homes for their participation in a $97 million Medicare fraud scheme.

The Justice Department announced today that it has reached an agreement in principle with the city of New York and intervening plaintiffs to settle an employment discrimination lawsuit involving the New York City Fire Department.

Five California-based masonry subcontractors and two individuals paid the government nearly $1.9 million to resolve allegations that they violated the False Claims Act by misrepresenting their disadvantaged small business status in connection with military construction contracts.

Following the recent tragedies at a Jewish Community Center in Kansas and at Ft. Hood, Attorney General Eric Holder urged Congress Tuesday to approve $15 million in funding for active shooter training for law enforcement officers to ensure they have the tools they need to effectively respond to threats, protect themselves, and save innocent lives.

The Department of Justice announced today that CRC Health Corp. (CRC) has agreed to pay $9.25 million to the federal government and the State of Tennessee to settle allegations that CRC knowingly submitted false claims by providing substandard treatment to adult and adolescent Medicaid patients suffering from alcohol and drug addiction at its facility in Burns, Tenn.

A federal jury in Detroit today convicted a physical therapist, physical therapy assistant and unlicensed doctor for their participation in a nearly $15 million Medicare fraud scheme.

Attorney General Eric Holder and Department of Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that a nationwide takedown by Medicare Fraud Strike Force operations in six cities has resulted in charges against 90 individuals.

A total of 19 individuals were arrested across the United States and internationally on charges brought by federal prosecutors in Mississippi, South Carolina and Georgia.

Medtronic Inc., of Fridley, Minnesota, has agreed to pay the United States $9.9 million to resolve allegations under the False Claims Act that the company used various types of payments to induce physicians to implant pacemakers and defibrillators manufactured and sold by Medtronic.

The Department of Justice and the Consumer Financial Protection Bureau (CFPB) today announced a settlement to resolve allegations that GE Capital Retail Bank, known as of this month as Synchrony Bank, engaged in a nationwide pattern or practice of discrimination by excluding Hispanic borrowers from two of its credit card debt-repayment programs

JC Stamps, a former union official, pleaded guilty today to embezzling more than $190,000 from two labor organizations he founded and an employee benefit plan

According to court documents submitted today, BNP Paribas S.A. (BNPP), a global financial institution headquartered in Paris, agreed to enter a guilty plea to conspiring to violate the International Emergency Economic Powers Act (IEEPA) and the Trading with the Enemy Act (TWEA) by processing billions of dollars of transactions through the U.S. financial system on behalf of Sudanese, Iranian, and Cuban entities subject to U.S. economic sanctions

The Department of Justice announced today that it will be co-hosting the historic program and celebration, “The 50 th Anniversary of the Civil Rights Act of 1964: Preserving Progress, Charting the Future,” with Howard University on July 15, 2014. Signed into law by President Lyndon B. Johnson on July 2, 1964, the groundbreaking act outlawed discriminatory voting requirements and segregation in schools, employment and places of public accommodation. Attorney General Eric Holder has made protecting civil rights a top priority of his administration of the Department of Justice

Attorney General Eric Holder will deliver the keynote address at the Department of Justice’s 50th anniversary celebration of the Civil Rights Act of 1964. Secretary of Labor Thomas Perez, Secretary of Education Arne Duncan, Congresswoman Eleanor Holmes Norton, Deputy Attorney General James Cole, Associate Attorney General Tony West, Ambassador Andrew Young and Howard University Interim President Dr. Wayne A.I. Frederick will also deliver remarks at the event co-hosted by Howard University, on TUESDAY, JULY 15, 2014, at 10:00 a.m. EDT, to honor the civil rights movement and celebrate the groundbreaking act

"We must recommit ourselves to the legacies of visionary leaders and courageous citizens who made the passage of the Civil Rights Act, and the creation of this agency, possible. And we must resolve to keep moving forward together – as one nation and one people – driven by the needs that remain unfulfilled, determined to transcend the barriers that still divide us, and dedicated to the enduring promise of equal justice under law."

History is not just a series of events; it is the people who create those events. It is the impact of the stories—told and untold—of the many trailblazers and unsung heroes whose tireless sacrifices and relentless dedication have resulted in justice, equality, opportunity, and freedom for all.

"My Brother's Keeper is about letting young people take responsibility for themselves and realizing success on their own terms. Those of us in positions of leadership -- we need to do our part to make sure you have a fair shot at your dreams; that you're not being held back by bias and discrimination; that the justice system designed to protect your rights is treating you fairly. That's our job."

The Justice Department announced today that Community Health Systems Inc. (CHS), the nation’s largest operator of acute care hospitals, has agreed to pay $98.15 million to resolve multiple lawsuits alleging that the company knowingly billed government health care programs for inpatient services that should have been billed as outpatient or observation services. The settlement also resolves allegations that one of the company’s affiliated hospitals, Laredo Medical Center (LMC), improperly billed the Medicare program for certain inpatient procedures and for services rendered to patients referred in violation of the Physician Self-Referral Law, commonly known as the Stark Law. CHS is based in Franklin, Tennessee, and has 206 affiliated hospitals in 29 states

Berkshire Hathaway Inc. has agreed to pay an $896,000 civil penalty to settle charges that it violated premerger reporting and waiting requirements when it acquired voting securities of USG Corp., the Department of Justice announced today

Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company.

DB Group Services (UK) Limited, a wholly owned subsidiary of Deutsche Bank AG (Deutsche Bank), has agreed to plead guilty to wire fraud for its role in manipulating the London Interbank Offered Rate (LIBOR), a leading benchmark interest rate used in financial products and transactions around the world

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate   What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html   Updates from Health Canada Type of Update and Link Date Posted Notice – Update to Clinical Trial Site Information Form 29 November …

Continue reading »

By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages …

Continue reading »

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

Continue reading »

The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome.

Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science.

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

Today's Daily Dose brings you news about the revised FDA decision date for Bristol Myers' CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma's primary biliary cholangitis trial results; MacroGenics' anticipated clinical data read-outs and regulatory event for this year and Trovagene's name change.

Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

Life sciences company LabCorp (LH) announced Tuesday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 at-home test kit.

Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

These are exciting times for Vapotherm Inc. (VAPO) whose share price has almost doubled in value since the beginning of this year.

Today's Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara's pivotal KALM-2 trial; LabCorp's at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant's much-awaited clinical trial catalyst.

Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.

In the span of just a few short months, the ramifications and impact of COVID-19 have been vast. Virtually every aspect of public health has been affected by this pandemic, and the fight against antibiotic-resistant bacteria is no exception.