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Detroit-Area Doctor Admits to Providing Medically Unnecessary Chemotherapy to Patients

A Detroit-area hematologist-oncologist pleaded guilty today for his role in a health care fraud scheme, admitting that he administered unnecessary chemotherapy to fraudulently bill the Medicare program and private insurance companies. According to court records, the scheme enabled the doctor to submit approximately $225 million in claims to Medicare over six years.



  • OPA Press Releases

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Pennsylvania Man Pleads Guilty in Conspiracy to Illegally Export Restricted Laboratory Equipment to Syria

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law



  • OPA Press Releases

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Two Former Rabobank Traders Indicted for Alleged Manipulation of U.S. Dollar, Yen Libor Interest Rates

Two former Coöperatieve Centrale Raiffeisen-Boerenleenbank B



  • OPA Press Releases

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Alabama Real Estate Investor Pleads Guilty to Conspiracy to Commit Mail Fraud

An Alabama real estate investor pleaded guilty yesterday for his role in a conspiracy to commit mail fraud related to public real estate foreclosure auctions held in southern Alabama, the Department of Justice announced today



  • OPA Press Releases

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Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud at Public Foreclosure Auctions

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



  • OPA Press Releases

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Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis

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.



  • OPA Press Releases

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Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions

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



  • OPA Press Releases

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Deutsche Bank's London Subsidiary Agrees to Plead Guilty in Connection with Long-Running Manipulation of LIBOR

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



  • OPA Press Releases

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Former Owner of Empire Towers Pleads Guilty for Fraudulent $7 Million Bond Scheme and Filing False Tax Return

Misled More Than 50 Individual Investors Who Bought Bonds

A former Queenstown, Maryland, resident pleaded guilty today to securities fraud and filing a false tax return



  • OPA Press Releases

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Father Of Former Investment Bank Managing Director Pleads Guilty To Insider Trading Conspiracy

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



  • OPA Press Releases

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Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions

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



  • OPA Press Releases

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Former California Attorney Pleads Guilty in International Investment Fraud Scheme

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



  • OPA Press Releases

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Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses

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



  • OPA Press Releases

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Former Postal Clerk Pleads Guilty to Stealing Mail

NORFOLK, Va



  • OPA Press Releases

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New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors

ALEXANDRIA, Va



  • OPA Press Releases

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Former Fox News Commentator Pleads Guilty to Fraud

ALEXANDRIA, Va



  • OPA Press Releases

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Alexandria Adult Day Healthcare Center Settles Civil Fraud Allegations

ALEXANDRIA, Va



  • OPA Press Releases

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Former Director of General Services Administration Division and Husband Indicted for Fraud and Nepotism

ALEXANDRIA, Va



  • OPA Press Releases

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Toano Man Pleads Guilty to Impersonating a Federal Agent

NEWPORT NEWS, Va



  • OPA Press Releases

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Former Nurse Pleads Guilty to ID Theft and Bank Fraud

RICHMOND, Va



  • OPA Press Releases

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What’s New Health Canada? November 2019 Updates

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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New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings

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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New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

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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What’s New Health Canada? January and February 2020 Updates

  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: Product Monograph Implementation Plans 13 January 2020 …

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New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings

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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New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings

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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Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

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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New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings

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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What’s New Health Canada?

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   New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the …

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SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch

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.




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Axsome Therapeutics (AXSM) Advances To Cross $100-Mark

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




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Avadel (AVDL) Soars On REST-ON Trial Results

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.




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Gilead's Remdesivir Becomes 1st Drug Allowed For Emergency Use For COVID-19

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.




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FDA Decision On BMY's Drug Postponed, ENTA's PBC Study Fails, MGNX Turns Heads

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.




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Relmada Therapeutics (RLMD): Sending The Right Signals?

Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37.




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HIAs and Other Resources to Advance Health-Informed Decisions

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.




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Policy Priorities to Address Opioid Use Disorder

Individuals with opioid use disorder (OUD) struggle to get effective care: Of 2 million Americans with the illness, only 26% receive treatment. Now, as the coronavirus pandemic presents an added strain on the U.S. health care system, it is creating greater hardships for those seeking OUD treatment.




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Pew Calls On DEA to Expedite Addiction Treatment Regulation

Pew’s substance use prevention and treatment initiative sent a letter to the Drug Enforcement Administration (DEA) on April 27 encouraging the agency to expedite a final rule that will help opioid treatment programs (OTPs)—federally regulated facilities where patients take medications for opioid use disorder under the supervision of medical staff and receive counseling and other care services—...




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Some Indicators of Public Health in Philadelphia Had Improved Before COVID-19

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.




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Pew Urges Congress to Promote Patient Matching in Electronic Health Records to Address COVID-19

The Pew Charitable Trusts sent a letter May 4 to the leaders of the Senate and House of Representatives urging them to support improved patient matching in electronic health records to help combat the COVID-19 pandemic.




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Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.




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Ordinary People Achieving The Extraordinary: Lessons In Leadership From The Court To The C-suite

This blog was written by Josh Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC. I stood in front of 15 skeptical parents and prepared to sell them on an improbable mission. They had

The post Ordinary People Achieving The Extraordinary: Lessons In Leadership From The Court To The C-suite appeared first on LifeSciVC.




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Long-Range Planning (LRP): Reframed Leaders Require Purpose

This blog was written by Rene Russo, CEO of Xilio Therapeutics, as part of the From The Trenches feature of LifeSciVC. In an environment where senior leaders are tasked with defining agile strategies in uncertain times, there are many perspectives

The post Long-Range Planning (LRP): Reframed Leaders Require Purpose appeared first on LifeSciVC.




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Amin Talati Continues its Expansion in Washington DC With Addition Of Dietary Supplement Industry Leader

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.




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'Doctor' Tony Huge: Brand Ambassador or Founder/Boss of Enhanced Athlete?

New Legal Motion Challenges Tony Huge’s Supposed Unpaid Role in Enhanced Athlete




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Organic Trade Association and The Organic Center Applaud Senate Bill, Organic Agriculture Research

The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018.




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PR—The Most Important Part of Trade Show Marketing

Natural product brands can boost trade show ROI by investing in PR to work with trade press via press releases and onsite interviews.




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Ad Agency Settles FTC, Maine AG Complaint

An advertising agency agreed to settle a complaint brought by state and federal regulators over the creation and dissemination of allegedly deceptive radio advertisements for weight-loss products.




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Immunity products: "This is the world's biggest ever advertising campaign, bar none"

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.



  • Markets and Trends

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The inside-out beauty boom? Nutricosmetics start-up D+ For Care says ‘the whole world is ready’

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.