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People Don't Have to Succumb to Anxiety during This Pandemic

That emotion is natural in a situation like this, but there are ways to mitigate it

-- Read more on ScientificAmerican.com




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Government Watchdog Chides FEMA for Lax Flood Enforcement

The agency fell well short of its goal of evaluating local flood control efforts every five years

-- Read more on ScientificAmerican.com




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Cleaner Air Courtesy of Coronavirus Provides Window into a Car-Free Future

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com




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Majority of Americans Open to Clinical Trial Participation If Recommended by a Doctor, New Study Finds

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....




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ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.




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Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials

On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.




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Bayer donates 8 million chloroquine tablets to the German Federal Government

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19




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Methadone to be supplied without new prescription during Covid-19 crisis

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

Continue reading...




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Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.




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Italy to relax COVID-19 lockdown in early May

Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic.




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More than half of US states will relax lockdowns by the end of the week

Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns.




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Imperial College London to lead major coronavirus home testing programme

Aims to track the progress of the infection across the UK




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World leaders donate to COVID-19 vaccine funding drive

Experts says $20bn needed to vaccinate global population




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Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report

Click to view a price quote on AGN.




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AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.




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Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.




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GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.




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Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 




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Indonesia reports 533 new COVID-19 cases, biggest in a day

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.




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Half of Spaniards will see lockdown eased from Monday as death toll falls

Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns.




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Former Employees of Emergency Vehicle Vendors Sentenced for Conspiring to Defraud Employers on Homeland Security Contract

Two Florida homeland security vendor employees were sentenced today for conspiracy to commit wire fraud and honest services fraud by depriving their employers of money and the right of honest services, the Department of Justice announced today.



  • OPA Press Releases

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Justice Department Seeks to Shut Down Texas Tax Preparers

The United States has sued a Dallas tax preparer, Tina Preston, her tax-preparation firm – Preston Tax Services, Inc. – and several other individuals associated with the firm, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Dallas with the U.S. District Court for the Northern District of Texas.



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U.S. Asks Federal Court to Shut Down Iowa Tax Preparers

The United States has sued a Clive, Iowa, couple to bar them from preparing federal tax returns for others. According to the government complaint, Jill Schwartz-Musin, her husband Howard Musin, and their business, SSC Services, prepare fraudulent federal income tax returns for small business owners.



  • OPA Press Releases

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Justice Department Seeks to Shut Down Sacramento Tax Preparation Firm

The United States has sued a Sacramento, Calif., tax preparer, Chris Elmer, his firm – Associated Tax Planners Inc. (ATP) – and several members of his family associated with ATP, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Sacramento with the U.S. District Court for the Eastern District of California.



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U.S. Court Permanently Shuts Down Two Pennsylvania Tax Preparers

A federal judge in Pennsylvania has permanently barred Chalamar Muhammad and her husband, Curtis Muhammad, from preparing tax returns for others. Judge Harvey Bartle III of the U.S. District Court for the Eastern District of Pennsylvania entered the order of permanent injunction after the Coatesville, Pa., couple failed to defend against the government’s allegations.



  • OPA Press Releases

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John Doe # 17 Indicted in Child Pornography Case

“John Doe 17,” a white male with curly brown hair weighing approximately 210-250 pounds, has been indicted by a federal grand jury for transporting child pornography via the Internet on or about May 5, 2007. This is the seventeenth such case to be investigated and the twelfth prosecuted through the Endangered Child Alert Program (ECAP), which was initiated by the Criminal Division’s Child Exploitation and Obscenity Section (CEOS) and the FBI in 2004. The program uses national and international media exposure of unknown adult perpetrators featured in child pornography in an effort to identify, locate, apprehend and prosecute such offenders and to rescue abused children.



  • OPA Press Releases

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Department of Justice Statement on the Abandonment of the JBS/National Beef Transaction

The Department issued a statement today after JBS and National Beef announced the abandonment of the JBS/National Beef transaction, which the Department had filed suit to block in October.



  • OPA Press Releases

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United States Transfers Binyam Mohammed to United Kingdom

The Department announced the transfer to the United Kingdom of Binyam Mohammed, an Ethiopian national and former resident of the United Kingdom who had been held at the Guantanamo detention facility since 2004.



  • OPA Press Releases

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United States Sues to Shut Down Florida Tax Return Preparer

The United States has filed suit against a Jacksonville, Fla., tax return preparer, seeking to shut down her business. According to the government complaint, Shirley Clark, who operates the Nichet Corp., has prepared at least 1,250 federal tax returns for her customers from 2004 until 2007 and, on those returns, Clark has claimed nearly $750,000 in fraudulent fuel tax credits.



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Federal Court Permanently Bars Florida “Tax Doctor” from Preparing Tax Returns

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.



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Falls Church, Va., Man Pleads Guilty to Harboring Indonesian Aliens for Financial Gain

Soripada Lubis, a naturalized American citizen originally from Indonesia, pleaded guilty today to harboring illegal aliens for commercial advantage and private financial gain. Lubis’ wife, Siti Chadidjah Siregar, a citizen of Indonesia, pleaded guilty to making false statements to federal agents who were investigating the scheme.



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U.S. Asks Courts in California & South Carolina to Shut Down Promoters of Allegedly Fraudulent $39.2 Million Tax Refund Scam

The United States has sued tax return preparers in Placerville, Calif., and Columbia, S.C., seeking to bar them from preparing federal tax returns for others. According to the government complaints in the two cases, Teresa Marty of Pollock Pines, Calif., and Winston Able of Blythewood, S.C., prepare federal income tax returns for their customers that claim fraudulent tax refunds.



  • OPA Press Releases

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60th Felony Conviction Obtained in Software Piracy Crackdown “Operation Fastlink”

The 60th felony conviction from Operation Fastlink, a major Department of Justice initiative to combat online piracy worldwide. Bryan Thomas Black, 30, of Waterloo, Ill., pleaded guilty today to one count of conspiracy to commit criminal infringement of a copyright for his involvement in a multinational software piracy organization that was targeted by investigators as part of “Operation Fastlink,” an internationally coordinated 18-month investigation.



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Federal Court Shuts Down North Carolina Tax Preparer

A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers’ non-deductible personal expenses.



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Justice Department Seeks to Shut Down Florida Tax Preparer

The United States has sued a Fort Richey, Fla., tax preparer, Frank Lighty, and his tax-preparation firm – Lighty & seeking to bar them permanently from the tax preparation business. The civil injunction suit was filed in Tampa with the U.S. District Court for the Middle District of Florida.



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Jury Convicts Two Doctors and Two Medical Assistants in $5.3 Million Medicare Fraud Scam

A federal jury in Miami today convicted two physicians and two medical assistants in connection with a $5.3 million Medicare fraud scheme. After a two-week trial in federal court in Miami, a jury found David Rothman, M.D., 66; Keith Russell, M.D., 65; Eda Marietta Milanes, 43; and Jorge Luis Pacheco, 50; guilty on all charged counts, including conspiracy to commit health care fraud and multiple counts of health care fraud for submitting claims to Medicare for unnecessary medications.



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Two Doctors and Two Medical Assistants Plead Guilty in $10 Million Medicare Fraud Scheme

Four Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Roberto Rodriguez, 54; Dr. Carlos Garrido, 69; Gonzalo Nodarse, 38; and Alexis Carrazana, 41; all pleaded guilty before U.S. District Judge Paul C. Huck to one count of conspiracy to commit health care fraud.



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Federal Judge Shuts Down Two Dallas Tax Preparers

A federal court has shut down two Dallas tax preparers during the height of tax-filing season. Chief Judge Sidney Fitzwater of the U.S. District Court for the Northern District of Texas signed a temporary restraining order barring Ethel Washington from preparing any tax returns. The court has also permanently barred Washington’s former employer, Tina Preston, and her firm, The Preston Group & Associates Inc., from preparing federal tax returns.



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Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy

A Newton, Conn., resident who was involved in operating three businesses in Brooklyn, N.Y., pleaded guilty to conspiring to defraud the Internal Revenue Service (IRS). Mariusz Debowksi pleaded guilty in U.S. District Court in Manhattan to conspiracy to aid another in filing false tax returns.



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Miami Doctor and Chemist Plead Guilty in HIV Infusion Fraud Scheme

Two Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Carmen Del Cueto, 65, and Alexis Dagnesses, 44, each pleaded guilty to one count of conspiracy to commit health care fraud before U.S. District Judge Paul C. Huck. Both defendants admitted to working at Midway Medical Center Inc. (Midway), a Miami clinic that purported to specialize in the treatment of patients with HIV.



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Statement of Attorney General Eric Holder Regarding United States V. Theodore F. Stevens

“In connection with the post-trial litigation in United States v. Theodore F. Stevens, the Department of Justice has conducted a review of the case, including an examination of the extent of the disclosures provided to the defendant. After careful review, I have concluded that certain information should have been provided to the defense for use at trial. In light of this conclusion, and in consideration of the totality of the circumstances of this particular case, I have determined that it is in the interest of justice to dismiss the indictment and not proceed with a new trial."



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Justice Department Asks Federal Court to Shut Down Iowa Tax Preparation Firm

The United States has brought suit in federal court against Gayle Lemmon of Humboldt, Iowa. The lawsuit seeks to bar her and her firm from preparing federal tax returns for others. According to the government complaint in the case, Lemmon’s firm, Gayle’s Bookkeeping and Tax Service Inc., prepares federal income tax returns for customers that unlawfully understate tax liabilities by claiming improper deductions for the business use of the home and for non-deductible personal expenses.



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Connecticut Resident Pleads Guilty to Multi-Million Dollar Tax Fraud Conspiracy Involving New York City Hospital

A Trumbull, Conn., resident who was involved in operating three businesses in Brooklyn, N.Y., pleaded guilty to conspiring to defraud the Internal Revenue Service (IRS). Krzysztof Koczon pleaded guilty in U.S. District Court in Manhattan to conspiracy to aid another in filing false tax returns.



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Federal, State Partners Announce Multi-Agency Crackdown Targeting Foreclosure Rescue Scams, Loan Modification Fraud

As homeowners and communities throughout the country continue to face devastating consequences from the deep contraction in the economy and the housing market, the Obama Administration today announced a new coordinated effort across federal and state government and the private sector to target mortgage loan modification fraud and foreclosure rescue scams that threaten to hurt American homeowners and prevent them from getting the help they need during these challenging times.



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Two Department of Defense Contractors Charged in Bribery Conspiracy Related to DOD Contracts in Afghanistan

Two Department of Defense (DOD) contractors were charged with conspiracy and bribery relating to their roles involving DOD contracts in Afghanistan. A Lebanese contracting company is also charged with participating in the same conspiracy.



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Federal Court Shuts Down Dallas Tax Preparer

A federal court in Dallas has permanently barred a Garland, Texas, man from preparing federal tax returns for others. Lucky Ngo, who operated “Lucky’s Translation and Tax Service” and “Water Inn,” prepared over 6,100 federal tax returns for customers since 2004, according to the government complaint filed in the civil injunction case. Ngo agreed to the permanent injunction order.



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Five Donaldson, Arkansas, Men Indicted on Federal Civil Rights Charges

A federal grand jury in Fort Smith, Ark., has indicted five men from the Donaldson, Ark., area on federal civil rights charges as well as charges of making false statements to the FBI.



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Deputy Attorney General David Ogden's Address at the American Bar Association Section of Litigation 2009 Annual Conference John Minor Wisdom Public Service and Professionalism Awards Luncheon

"To ensure that the Department holds itself to the highest standards during discovery -- as in every stage of litigation -- in our criminal cases, and also in our civil litigation, we have taken both short-term and long-term action."




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U.S. Court Shuts Down Georgia Tax Preparation Firms Allegedly Involved in Fuel Credit Tax Scam

A federal court in Savannah, Ga., today permanently barred Ophelia Kelley, of Vidalia, Ga., from preparing federal income tax returns for others. According to the government complaint, Kelley operated two return preparation firms in Vidalia – Kelley Tax Service and City and Country Girl Tax Service. Kelley agreed to the civil injunction order.



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U.S. Court in Seattle Permanently Shuts Down Washington, D.C., Tax Preparer

A federal judge in Seattle, Wash., has permanently barred a District of Columbia man, William H. Camp, Jr., from preparing tax returns for others and from promoting a scheme involving bogus gold mining tax deductions. The permanent injunction order was entered by Judge Ricardo S. Martinez of the U.S. District Court for the Western District of Washington, where a substantial number of Camp’s customers reside.



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