Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.

The Justice Department announced today that under its settlements with five of the nation’s largest mortgage servicers, 952 service members and their co-borrowers are eligible to receive over $123 million for non-judicial foreclosures that violated the Servicemembers Civil Relief Act (SCRA)

A Northern California real estate investor has agreed to plead guilty for his role in bid rigging and fraud conspiracies at public real estate foreclosure auctions in Northern California, the Department of Justice announced

Preet Bharara, the United States Attorney for the Southern District of New York, announced that ROBERT STEWART, the father of former investment bank managing director Sean Stewart, pled guilty today to participating in a conspiracy to trade on inside information about several mergers and acquisitions announced between 2011 and 2014

Preet Bharara, the United States Attorney for the Southern District of New York, Diego Rodriguez, the Assistant Director-in-Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”), and Philip R

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

A Georgia real estate investor pleaded guilty today for his role in conspiracies to rig bids and commit mail fraud at public real estate foreclosure auctions in Fulton and DeKalb counties, Georgia

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

A Las Vegas man pleaded guilty today to conspiracy for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses

A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors

ALEXANDRIA, Va

ALEXANDRIA, Va

NORFOLK, Va

ALEXANDRIA, Va

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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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 …

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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 …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS    Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and …

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By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below.  We note that approximately one-third of FDA’s guidances this past month are related to COVID-19.    Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and …

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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 …

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By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, …

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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.

The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

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.

Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint.

Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging.

Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel.

Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses.

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 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.

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.

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.

The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue?

As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be...

The COVID-19 pandemic is providing a grim reminder of an unfortunate truism: Public health often does not receive the attention it deserves until a disaster hits.

The Health Impact Project’s toolkit contains resources that help communities, agencies, and other organizations take action to improve public health. The toolkit offers a collection of health impact assessments, guides, and other research to support policymakers’ efforts to consider health when making decisions across sectors, such as housing, planning, and education.

The federal government in March released a pair of long-awaited rules that will give patients greater access to their health data and improve the flow of information across care settings.