l Attorney General Holder Remarks on Financial Fraud Prosecutions at NYU School of Law By www.justice.gov Published On :: Wed, 17 Sep 2014 14:28:51 EDT Thank you, Professor [Jennifer] Arlen, for those kind words – and thank you all for being here. It’s a privilege to be at New York University this afternoon Full Article Speech
l Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve By www.justice.gov Published On :: Thu, 18 Sep 2014 11:01:37 EDT Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice. Full Article OPA Press Releases
l Two Former Rabobank Traders Indicted for Alleged Manipulation of U.S. Dollar, Yen Libor Interest Rates By www.justice.gov Published On :: Thu, 23 Oct 2014 11:08:25 EDT Two former Coöperatieve Centrale Raiffeisen-Boerenleenbank B Full Article OPA Press Releases
l Five Northern California Real Estate Investors Indicted for Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Thu, 23 Oct 2014 11:08:23 EDT A federal grand jury in San Francisco returned an eight-count indictment against five real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced Full Article OPA Press Releases
l Alabama Real Estate Investor Pleads Guilty to Conspiracy to Commit Mail Fraud By www.justice.gov Published On :: Mon, 3 Nov 2014 14:58:31 EST 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 Full Article OPA Press Releases
l Eleven Northern California Real Estate Investors Indicted for Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 3 Dec 2014 09:45:53 EST A federal grand jury in San Francisco returned three multi-count indictments against eleven real estate investors for their role in bid rigging and fraud schemes at foreclosure auctions in Northern California, the Department of Justice announced Full Article OPA Press Releases
l Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud at Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 3 Dec 2014 09:45:52 EST 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 Full Article OPA Press Releases
l Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis By www.justice.gov Published On :: Tue, 3 Feb 2015 16:01:53 EST 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. Full Article OPA Press Releases
l Service Members to Receive Over $123 Million for Unlawful Foreclosures Under the Servicemembers Civil Relief Act By www.justice.gov Published On :: Thu, 9 Apr 2015 14:45:21 EDT 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) Full Article OPA Press Releases
l Northern California Real Estate Investor Agrees to Plead Guilty to Bid Rigging and Fraud Conspiracies at Public Foreclosure Auctions By www.justice.gov Published On :: Thu, 9 Apr 2015 12:52:09 EDT 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 Full Article OPA Press Releases
l Deutsche Bank's London Subsidiary Agrees to Plead Guilty in Connection with Long-Running Manipulation of LIBOR By www.justice.gov Published On :: Fri, 24 Apr 2015 09:35:43 EDT 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 Full Article OPA Press Releases
l Former Owner of Empire Towers Pleads Guilty for Fraudulent $7 Million Bond Scheme and Filing False Tax Return By www.justice.gov Published On :: Thu, 28 May 2015 13:20:24 EDT 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 Full Article OPA Press Releases
l Father Of Former Investment Bank Managing Director Pleads Guilty To Insider Trading Conspiracy By www.justice.gov Published On :: Wed, 12 Aug 2015 21:09:53 EDT 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 Full Article OPA Press Releases
l Defendant In Prior SEC Enforcement Action Arrested And Charged In Manhattan Federal Court For Scheme To Hide Assets From Court-Appointed Receiver And The Court By www.justice.gov Published On :: Wed, 26 Aug 2015 20:45:21 EDT 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 Full Article OPA Press Releases
l Deputy Attorney General Sally Quillian Yates Delivers Remarks at New York University School of Law Announcing New Policy on Individual Liability in Matters of Corporate Wrongdoing By www.justice.gov Published On :: Fri, 18 Dec 2015 11:45:41 EST 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 Full Article Speech
l Real Estate Investor Pleads Guilty to Bid Rigging and Fraud Conspiracies at Georgia Public Foreclosure Auctions By www.justice.gov Published On :: Wed, 7 Oct 2015 20:45:21 EDT 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 Full Article OPA Press Releases
l Deputy Attorney General Sally Quillian Yates Delivers Remarks at American Banking Association and American Bar Association Money Laundering Enforcement Conference By www.justice.gov Published On :: Fri, 18 Dec 2015 11:45:40 EST Remarks as prepared for delivery Thank you, Buddy [Wilmer Parker], for that kind introduction Full Article Speech
l Former California Attorney Pleads Guilty in International Investment Fraud Scheme By www.justice.gov Published On :: Wed, 25 Nov 2015 08:45:26 EST 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 Full Article OPA Press Releases
l Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme By www.justice.gov Published On :: Thu, 10 Dec 2015 08:45:28 EST 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 Full Article OPA Press Releases
l Owner of Three Los Angeles Clinics Sentenced to 78 Months in Prison for Medicare Fraud By www.justice.gov Published On :: Tue, 5 Jan 2016 11:45:28 EST The former owner and operator of three medical clinics located in Los Angeles was sentenced today to 78 months in prison for his role in a scheme that submitted more than $4 Full Article OPA Press Releases
l Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:24 EST 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 Full Article OPA Press Releases
l Morgan Stanley Agrees to Pay $2.6 Billion Penalty in Connection with Its Sale of Residential Mortgage Backed Securities By www.justice.gov Published On :: Wed, 17 Feb 2016 19:56:23 EST The Justice Department today announced that Morgan Stanley will pay a $2 Full Article OPA Press Releases
l Former California Attorney Sentenced to 60 Months for His Role in International Investment Fraud Scheme By www.justice.gov Published On :: Tue, 23 Feb 2016 20:45:29 EST 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 Full Article OPA Press Releases
l Former Postal Clerk Pleads Guilty to Stealing Mail By www.justice.gov Published On :: Wed, 23 Mar 2016 20:45:27 EDT NORFOLK, Va Full Article OPA Press Releases
l New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors By www.justice.gov Published On :: Tue, 29 Mar 2016 20:45:42 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Norfolk Man Sentenced to Prison for Mail and Wire Fraud By www.justice.gov Published On :: Thu, 28 Apr 2016 20:45:25 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
l Former Fox News Commentator Pleads Guilty to Fraud By www.justice.gov Published On :: Mon, 2 May 2016 08:45:35 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Former SunTrust Mortgage VP and Loan Officers Sentenced to Prison By www.justice.gov Published On :: Mon, 2 May 2016 08:45:35 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Alexandria Adult Day Healthcare Center Settles Civil Fraud Allegations By www.justice.gov Published On :: Wed, 4 May 2016 08:45:24 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Former Postal Worker Sentenced to Prison for Workers’ Comp Fraud By www.justice.gov Published On :: Thu, 5 May 2016 08:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
l Two Former Deutsche Bank Employees Indicted on Fraud Charges in Connection with Long-Running Manipulation of Libor By www.justice.gov Published On :: Thu, 2 Jun 2016 14:45:33 EDT Two former Deutsche Bank AG (Deutsche Bank) traders—the bank’s supervisor of the Pool Trading Desk in New York and a derivatives trader in London—were indicted for their alleged roles in a scheme to manipulate the U Full Article OPA Press Releases
l Former Director of General Services Administration Division and Husband Indicted for Fraud and Nepotism By www.justice.gov Published On :: Wed, 15 Jun 2016 14:45:25 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Former Loudoun County Sheriff’s Deputy Sentenced to Prison By www.justice.gov Published On :: Fri, 17 Jun 2016 20:45:22 EDT ALEXANDRIA, Va Full Article OPA Press Releases
l Toano Man Pleads Guilty to Impersonating a Federal Agent By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
l Former Nurse Pleads Guilty to ID Theft and Bank Fraud By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT RICHMOND, Va Full Article OPA Press Releases
l New FDA guidance on alternate approaches in premarket notification for Class II medical devices By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:09:57 +0000 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 … Continue reading » Full Article Cato Research FDA FDA Regulatory Guidances Medical Device FDA Guidances medical devices
l What’s New Health Canada? November 2019 Updates By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:41:48 +0000 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 » Full Article Canadian Regulatory Affairs Cato Research Health Canada regulatory
l What’s New Health Canada? January and February 2020 Updates By feedproxy.google.com Published On :: Wed, 04 Mar 2020 17:52:44 +0000 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 … Continue reading » Full Article Health Canada Updates Health Canada Regulatory Authorities
l Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic By feedproxy.google.com Published On :: Wed, 29 Apr 2020 13:00:12 +0000 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 » Full Article Clinical Trials CATOSMS COVID-19
l New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Fri, 01 May 2020 21:21:17 +0000 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, … Continue reading » Full Article FDA Regulatory Guidances CATO SMS FDA Guidances
l What’s New Health Canada? By feedproxy.google.com Published On :: Thu, 07 May 2020 21:44:25 +0000 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 … Continue reading » Full Article Canadian Regulatory Affairs Cato Research Health Canada CATOSMS
l Shot Roster: COVID-19 Vaccines In Human Trials By www.rttnews.com Published On :: Fri, 01 May 2020 00:58:48 GMT 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. Full Article
l FDA Approves NASA-Developed Ventilator For Emergency Use By www.rttnews.com Published On :: Fri, 01 May 2020 09:51:13 GMT 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. Full Article
l SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch By www.rttnews.com Published On :: Fri, 24 Apr 2020 05:43:19 GMT 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. Full Article
l Vir Biotechnology, Alnylam Identify VIR-2703 Candidate For Treatment Of COVID-19 By www.rttnews.com Published On :: Mon, 04 May 2020 11:51:31 GMT 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. Full Article
l Lupin Pharma: Phase 3 Trial Of Single-Dose Solosec Met Primary Endpoint By www.rttnews.com Published On :: Mon, 04 May 2020 11:56:29 GMT Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis. Full Article
l Junshi, Eli Lilly Agree To Co-develop JS016 Antibodies Against COVID-19 By www.rttnews.com Published On :: Mon, 04 May 2020 12:38:58 GMT 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. Full Article
l RedHill Biopharma Provides Update On Compassionate Use Program With Opaganib By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:37:16 GMT 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. Full Article
l Avadel (AVDL) Soars On REST-ON Trial Results By www.rttnews.com Published On :: Mon, 27 Apr 2020 12:11:18 GMT 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. Full Article
l FDA Warns Of Risks Related To Use Of Anti-malaria Drugs For COVID-19 By www.rttnews.com Published On :: Mon, 27 Apr 2020 13:03:03 GMT 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. Full Article
