y 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
y 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
y 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
y 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
y 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
y 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
y Former Idaho Construction Company President Sentenced to Prison for Fraud Scheme By www.justice.gov Published On :: Mon, 8 Feb 2016 20:45:26 EST The former president and majority stockholder of a construction company was sentenced to five years in prison today following her plea of guilty to filing a false tax return and her conviction by a jury of conspiracy to defraud the United States, wire fraud, mail fraud, false statements, interstate transportation of property taken by fraud, conspiracy to obstruct justice and obstruction of justice, announced Acting Assistant Attorney General Caroline D. Ciraolo of the Justice Department’s Tax Division and U.S. Attorney Wendy J. Olson for the District of Idaho. Full Article OPA Press Releases
y 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
y 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
y 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
y 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
y 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
y 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
y Navy Senior Chief Indicted in ID Theft and Bank Fraud Scheme By www.justice.gov Published On :: Thu, 5 May 2016 20:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
y 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
y 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
y 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
y 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
y New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Mon, 06 Jan 2020 21:36:51 +0000 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 » Full Article FDA Regulatory Guidances FDA Guidances
y New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Tue, 04 Feb 2020 20:21:28 +0000 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 … Continue reading » Full Article FDA FDA Regulatory Guidances Rare Diseases Regulatory Affairs Cato Research FDA Guidances rare diseases
y 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
y New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Wed, 04 Mar 2020 18:28:34 +0000 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 … Continue reading » Full Article FDA Regulatory Guidances CATOSMS FDA FDA Guidances Regulatory Authorities
y New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Mon, 06 Apr 2020 20:00:27 +0000 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 … Continue reading » Full Article FDA Regulatory Guidances Cato Research FDA FDA Guidances
y 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
y 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
y Curious to know if Bitcoin is here to stay ? By www.rttnews.com Published On :: Sat, 09 May 2020 15:15:05 GMT Read the latest developments from the cryptocurrency space, breaking news and analysis on Bitcoin and blockchain on RTTNews. Know more about altcoins, mining, ICOs, warnings and regulation. Find out how to acquire and trade digital currencies. Full Article
y 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
y 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
y 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
y 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
y Sutro Biopharma Reports Updated Data From Ovarian Cancer Study By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:35:52 GMT 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. Full Article
y Gilead's Remdesivir Becomes 1st Drug Allowed For Emergency Use For COVID-19 By www.rttnews.com Published On :: Sat, 02 May 2020 02:41:07 GMT 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. Full Article
y FDA Decision On BMY's Drug Postponed, ENTA's PBC Study Fails, MGNX Turns Heads By www.rttnews.com Published On :: Thu, 07 May 2020 03:33:38 GMT 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. Full Article
y Will Krystal (KRYS) Continue To Shine? By www.rttnews.com Published On :: Thu, 07 May 2020 09:23:26 GMT Shares of Krystal Biotech Inc. (KRYS) have now more than doubled in value since touching a 52-week low of $22.02 on June 14, 2019. Full Article
y IMMU Gets Early FDA Nod, KNSA's PN Trial Meets Goals, MYOV In Good Spirits By www.rttnews.com Published On :: Thu, 23 Apr 2020 06:16:08 GMT 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. Full Article
y Ocean Spray Recalls Pink Lite Cranberry Juice For Undeclared Sulfites By www.rttnews.com Published On :: Thu, 23 Apr 2020 11:43:59 GMT Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail Full Article
y FDA Gives Nod To Medtronic's Hemodialysis Device For Pediatric Patients By www.rttnews.com Published On :: Thu, 30 Apr 2020 12:15:55 GMT 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. Full Article
y CYCC In STOPCOVID, EXEL Hits New High, NVS Trialing Malaria Drug For COVID-19 By www.rttnews.com Published On :: Tue, 21 Apr 2020 05:39:42 GMT 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. Full Article
y Biotech Stocks Facing FDA Decision In May 2020 By www.rttnews.com Published On :: Tue, 28 Apr 2020 02:29:38 GMT So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year. Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May 2020. Full Article
y ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll By www.rttnews.com Published On :: Wed, 06 May 2020 05:15:35 GMT 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. Full Article
y Vapotherm's (VAPO) Journey From $9 To $22 In 6 Months, More In Store? By www.rttnews.com Published On :: Wed, 06 May 2020 07:52:11 GMT These are exciting times for Vapotherm Inc. (VAPO) whose share price has almost doubled in value since the beginning of this year. Full Article
y Israel-based Ayala Pharma To Debut On Nasdaq On May 7 By www.rttnews.com Published On :: Wed, 06 May 2020 11:47:24 GMT Israel-based Ayala Pharmaceuticals is slated to debut on the Nasdaq Global Select Market, under the symbol 'AYLA', on May 7, 2020. Full Article
y LIFE In COVID-19 Battle, LH On Watch, CARA Keeps KALM, All Eyes On MYOV By www.rttnews.com Published On :: Wed, 22 Apr 2020 04:56:54 GMT 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. Full Article
y BPMC's VOYAGER Fails, CLSD's NDA Resubmission Faces Delay, SNDX Hits New High By www.rttnews.com Published On :: Wed, 29 Apr 2020 04:59:15 GMT 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. Full Article
y Do You Have These Stocks In Your Portfolio? (SNDX, ERYP, IMRA...) By www.rttnews.com Published On :: Wed, 29 Apr 2020 10:08:05 GMT The following are some of the stocks in the healthcare sector that touched a high yesterday. Will the rally continue? Full Article
y Antibiotics Currently in Global Clinical Development By feedproxy.google.com Published On :: Wed, 15 Apr 2020 16:29:00 -0400 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... Full Article
y The Invaluable Role of Antibiotics—in a Pandemic and Beyond By feedproxy.google.com Published On :: Thu, 16 Apr 2020 09:31:00 -0400 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. Full Article
y Six Ways New Federal Health IT Rules Improve Both Care and Public Health By feedproxy.google.com Published On :: Fri, 17 Apr 2020 09:26:15 -0400 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. Full Article
y Policy Priorities to Address Opioid Use Disorder By feedproxy.google.com Published On :: Thu, 23 Apr 2020 07:00:00 -0400 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. Full Article
y Policy Changes Could Bolster Prescription Drug Monitoring Programs By feedproxy.google.com Published On :: Thu, 23 Apr 2020 07:00:00 -0400 High rates of opioid prescribing have contributed to the current U.S. opioid epidemic and the steady increase in overdose deaths across the country. Prescribers wrote an all-time high of 255 million opioid prescriptions in 2012, and though that rate has since declined. Full Article
